{"protocolSection":{"identificationModule":{"nctId":"NCT04969939","orgStudyIdInfo":{"id":"NN9775-4708"},"secondaryIdInfos":[{"id":"U1111-1254-9046","type":"OTHER","domain":"WHO"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity","officialTitle":"Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity"},"statusModule":{"statusVerifiedDate":"2026-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-07-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-12-06","type":"ACTUAL"},"completionDateStruct":{"date":"2023-01-30","type":"ACTUAL"},"studyFirstSubmitDate":"2021-07-09","studyFirstSubmitQcDate":"2021-07-09","studyFirstPostDateStruct":{"date":"2021-07-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-12-03","resultsFirstSubmitQcDate":"2026-01-07","resultsFirstPostDateStruct":{"date":"2026-01-08","type":"ACTUAL"},"dispFirstSubmitDate":"2023-12-05","dispFirstPostDateStruct":{"date":"2026-01-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-01-07","lastUpdatePostDateStruct":{"date":"2026-01-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a \"dummy\" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.\n\nPart 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":120,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 2.4 mg and NNC0165-1875 2.0 mg","type":"EXPERIMENTAL","description":"Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg","interventionNames":["Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg"]},{"label":"Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)","type":"PLACEBO_COMPARATOR","description":"Participants will receive placebo as an add on to semaglutide 2.4 mg.","interventionNames":["Drug: Semaglutide 2.4 mg and placebo 2.0 mg"]},{"label":"Semaglutide 2.4 mg and NNC0165-1875 1.0 mg","type":"EXPERIMENTAL","description":"Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg","interventionNames":["Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg"]},{"label":"Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)","type":"PLACEBO_COMPARATOR","description":"Participants will receive placebo as an add on to semaglutide 2.4 mg.","interventionNames":["Drug: Semaglutide 2.4 mg and placebo 1.0 mg"]}],"interventions":[{"type":"DRUG","name":"Semaglutide 2.4 mg and NNC0165-1875 2.0 mg","description":"NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.","armGroupLabels":["Semaglutide 2.4 mg and NNC0165-1875 2.0 mg"]},{"type":"DRUG","name":"Semaglutide 2.4 mg and placebo 2.0 mg","description":"NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.","armGroupLabels":["Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)"]},{"type":"DRUG","name":"Semaglutide 2.4 mg and NNC0165-1875 1.0 mg","description":"NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.","armGroupLabels":["Semaglutide 2.4 mg and NNC0165-1875 1.0 mg"]},{"type":"DRUG","name":"Semaglutide 2.4 mg and placebo 1.0 mg","description":"NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.","armGroupLabels":["Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Part 1: Number of Treatment-emergent Adverse Events (TEAEs)","description":"A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.","timeFrame":"Part 1: From time of dosing (day 1) to follow-up (week 24)"},{"measure":"Part 2b: Percentage Change in Body Weight","description":"Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2: Randomisation (week 32), end of treatment (week 48)"}],"secondaryOutcomes":[{"measure":"Part 2b: Change in Body Weight (kg)","description":"Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Change in Fasting Plasma Glucose (FPG)","description":"Change in FPG (measured in millimoles per liter \\[mmol/l\\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Change in Fasting Insulin","description":"Change in fasting insulin (measured in picomoles per liter \\[pmol/l\\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Change in Waist Circumference","description":"Change in waist circumference (measured in centimeter \\[cm\\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)","description":"Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)","description":"Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)","description":"Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)","description":"Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)","description":"Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)","description":"Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)"},{"measure":"Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)","description":"An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"From randomisation (week 32) to end of the trial (week 56)"},{"measure":"Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)","description":"A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","timeFrame":"From randomisation (week 32) to end of the trial (week 56)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n* BMI 30.0-45.0 kg/m\\^2 (both inclusive) at the screening visit.\n\nExclusion Criteria:\n\n* HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.\n\n  * History of type 1 or type 2 diabetes mellitus.\n  * Treatment with glucose-lowering agent(s) within 90 days before screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Univ of Alabama Birmingham","city":"Birmingham","state":"Alabama","zip":"35294","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Profil Institute For Clinical Research Inc","city":"Chula Vista","state":"California","zip":"91911","country":"United States","geoPoint":{"lat":32.64005,"lon":-117.0842}},{"facility":"Velocity Clin Res Los Angeles","city":"Los Angeles","state":"California","zip":"90017","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Jacksonville Ctr For Clin Res","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Endo Res Solutions Inc","city":"Roswell","state":"Georgia","zip":"30076","country":"United States","geoPoint":{"lat":34.02316,"lon":-84.36159}},{"facility":"East West Med Res Inst","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Evanston Premier Hlthcr Res","city":"Skokie","state":"Illinois","zip":"60077","country":"United States","geoPoint":{"lat":42.03336,"lon":-87.73339}},{"facility":"Altasciences Clinical Kansas, Inc.","city":"Overland Park","state":"Kansas","zip":"66212","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}},{"facility":"L-MARC Research Center","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"AMC Community Endocrinology","city":"Albany","state":"New York","zip":"12206","country":"United States","geoPoint":{"lat":42.65258,"lon":-73.75623}},{"facility":"NYC Research, Inc.","city":"New York","state":"New York","zip":"10016","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"PharmQuest Life Sciences LLC","city":"Greensboro","state":"North Carolina","zip":"27408","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"Accellacare","city":"Wilmington","state":"North Carolina","zip":"28401","country":"United States","geoPoint":{"lat":34.23556,"lon":-77.94604}},{"facility":"Medical Uni of SC Charleston","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"Coastal Carolina Res Ctr.","city":"North Charleston","state":"South Carolina","zip":"29405","country":"United States","geoPoint":{"lat":32.85462,"lon":-79.97481}},{"facility":"Texas Diabetes & Endocrinology, P.A._Austin","city":"Austin","state":"Texas","zip":"78749","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Soltero Cardiovascular Research Center","city":"Dallas","state":"Texas","zip":"75226","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Texas Diabetes & Endocrinology, P.A._Austin","city":"Round Rock","state":"Texas","zip":"78681","country":"United States","geoPoint":{"lat":30.50826,"lon":-97.6789}},{"facility":"Chrysalis Clinical Research","city":"St. George","state":"Utah","zip":"84790","country":"United States","geoPoint":{"lat":37.10415,"lon":-113.58412}},{"facility":"Washington Cntr Weight Mgmt","city":"Arlington","state":"Virginia","zip":"22206","country":"United States","geoPoint":{"lat":38.88101,"lon":-77.10428}},{"facility":"Health Res of Hampton Roads","city":"Newport News","state":"Virginia","zip":"23606","country":"United States","geoPoint":{"lat":36.98038,"lon":-76.42975}},{"facility":"National Clin Res Inc.","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Selma Medical Associates","city":"Winchester","state":"Virginia","zip":"22601-3834","country":"United States","geoPoint":{"lat":39.18566,"lon":-78.16333}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial consisted of part 1 and 2. Part 1: 24 weeks (16-week treatment + 8 week follow up). In part 1 participants received NNC0165-1875 1.0 milligrams (mg) / matching placebo or NNC0165-1875 2.0 mg / matching placebo with semaglutide 2.4 mg. Part 2 further consisted of open-label run-in part (part 2a) of 32 weeks where participants received semaglutide and part 2b of 16 weeks where participants received NNC0165-1875 or NNC0165-1875 placebo with semaglutide s.c. 2.4 mg and 8-week follow up.","recruitmentDetails":"The trial was conducted at 14 sites in the United States.","groups":[{"id":"FG000","title":"Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"FG001","title":"Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"FG002","title":"Part 1: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"FG003","title":"Part 2a (Run-in Period): Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg."},{"id":"FG004","title":"Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"FG005","title":"Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"FG006","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"periods":[{"title":"Part 1 (24 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]}]},{"title":"Part 2a: Run in Period (32 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"96"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"83"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"13"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]}]},{"title":"Part 2b (16 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","comment":"Participants who achieved target dose of semaglutide 2.4 mg in Run in part randomized to Part 2b.","numSubjects":"47"},{"groupId":"FG005","comment":"Participants who achieved target dose of semaglutide 2.4 mg in Run in part randomized to Part 2b.","numSubjects":"8"},{"groupId":"FG006","comment":"Participants who achieved target dose of semaglutide 2.4 mg in Run in part randomized to Part 2b.","numSubjects":"28"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"44"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety analysis set (SAS) included all participants randomly assigned to trial treatment and who took at least one dose of trial product.","groups":[{"id":"BG000","title":"Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"BG001","title":"Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"BG002","title":"Part 1: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"BG003","title":"Part 2","description":"All Participants randomised in Part 2."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"96"},{"groupId":"BG004","value":"120"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44","spread":"12"},{"groupId":"BG001","value":"45","spread":"14"},{"groupId":"BG002","value":"43","spread":"13"},{"groupId":"BG003","value":"50","spread":"13"},{"groupId":"BG004","value":"48.4","spread":"13.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"78"},{"groupId":"BG004","value":"91"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"18"},{"groupId":"BG004","value":"29"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"7"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"91"},{"groupId":"BG004","value":"113"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"5"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"29"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"71"},{"groupId":"BG004","value":"80"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Part 1: Number of Treatment-emergent Adverse Events (TEAEs)","description":"A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.","populationDescription":"SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Part 1: From time of dosing (day 1) to follow-up (week 24)","groups":[{"id":"OG000","title":"Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"OG001","title":"Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."},{"id":"OG002","title":"Part 1: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"37"}]}]}]},{"type":"PRIMARY","title":"Part 2b: Percentage Change in Body Weight","description":"Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"Full analysis set (FAS) included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in body weight","timeFrame":"Part 2: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.55","spread":"3.97"},{"groupId":"OG001","value":"-3.06","spread":"5.46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Week 48 responses were analysed using an analysis of covariance model with randomised treatment as factors and baseline body weight (kg) as covariate.","nonInferiorityType":"SUPERIORITY","pValue":"0.0437","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-point)","paramValue":"-2.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.24","ciUpperLimit":"-0.06"}]},{"type":"SECONDARY","title":"Part 2b: Change in Body Weight (kg)","description":"Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms (kg)","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.54","spread":"3.22"},{"groupId":"OG001","value":"-2.23","spread":"5.16"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.17","spread":"0.17"},{"groupId":"OG001","value":"-0.17","spread":"0.14"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Change in Fasting Plasma Glucose (FPG)","description":"Change in FPG (measured in millimoles per liter \\[mmol/l\\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all partcipants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/l","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.36"},{"groupId":"OG001","value":"-0.02","spread":"0.42"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Change in Fasting Insulin","description":"Change in fasting insulin (measured in picomoles per liter \\[pmol/l\\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pmol/l","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.10","spread":"39.31"},{"groupId":"OG001","value":"-8.10","spread":"47.22"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Change in Waist Circumference","description":"Change in waist circumference (measured in centimeter \\[cm\\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.80","spread":"6.92"},{"groupId":"OG001","value":"-2.69","spread":"5.73"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)","description":"Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"0.11"},{"groupId":"OG001","value":"1.07","spread":"0.17"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)","description":"Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"0.12"},{"groupId":"OG001","value":"1.08","spread":"0.12"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)","description":"Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"0.17"},{"groupId":"OG001","value":"1.08","spread":"0.27"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)","description":"Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"0.25"},{"groupId":"OG001","value":"1.04","spread":"0.27"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)","description":"Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"0.26"},{"groupId":"OG001","value":"1.03","spread":"0.26"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)","description":"Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"Part 2b: Randomisation (week 32), end of treatment (week 48)","groups":[{"id":"OG000","title":"Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.87","spread":"0.39"},{"groupId":"OG001","value":"1.07","spread":"0.48"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)","description":"An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From randomisation (week 32) to end of the trial (week 56)","groups":[{"id":"OG000","title":"Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG002","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"56"}]}]}]},{"type":"SECONDARY","title":"Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)","description":"A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.","populationDescription":"SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From randomisation (week 32) to end of the trial (week 56)","groups":[{"id":"OG000","title":"Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG001","title":"Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."},{"id":"OG002","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.","description":"All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.","eventGroups":[{"id":"EG000","title":"Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":8,"otherNumAtRisk":8},{"id":"EG001","title":"Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":1,"seriousNumAtRisk":8,"otherNumAffected":8,"otherNumAtRisk":8},{"id":"EG002","title":"Part 1: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":8,"otherNumAtRisk":8},{"id":"EG003","title":"Part 2a (Run-in Period): Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.","deathsNumAffected":0,"deathsNumAtRisk":96,"seriousNumAffected":2,"seriousNumAtRisk":96,"otherNumAffected":69,"otherNumAtRisk":96},{"id":"EG004","title":"Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).","deathsNumAffected":0,"deathsNumAtRisk":47,"seriousNumAffected":2,"seriousNumAtRisk":47,"otherNumAffected":36,"otherNumAtRisk":47},{"id":"EG005","title":"Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":7,"otherNumAtRisk":8},{"id":"EG006","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":16,"otherNumAtRisk":28}],"seriousEvents":[{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Tooth Abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":96},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Uterine Leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":96},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Abortion Spontaneous","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Clostridium difficile colitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]}],"otherEvents":[{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":8},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":8},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":8},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":96},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Depressive symptom","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Hypercalcaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Hypercalciuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 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