{"protocolSection":{"identificationModule":{"nctId":"NCT03496298","orgStudyIdInfo":{"id":"EFC14828"},"secondaryIdInfos":[{"id":"2017-002954-35","type":"EUDRACT_NUMBER"},{"id":"U1111-1186-2533","type":"OTHER","domain":"UTN"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Sanofi","class":"INDUSTRY"},"briefTitle":"Effect of Efpeglenatide on Cardiovascular Outcomes","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk","acronym":"AMPLITUDE-O"},"statusModule":{"statusVerifiedDate":"2021-08","overallStatus":"TERMINATED","whyStopped":"Sponsor decision to cancel TRIAL, not related to safety concern","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-04-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-12-10","type":"ACTUAL"},"completionDateStruct":{"date":"2020-12-10","type":"ACTUAL"},"studyFirstSubmitDate":"2018-04-05","studyFirstSubmitQcDate":"2018-04-05","studyFirstPostDateStruct":{"date":"2018-04-12","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-09-16","resultsFirstSubmitQcDate":"2021-09-16","resultsFirstPostDateStruct":{"date":"2021-10-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-09-16","lastUpdatePostDateStruct":{"date":"2021-10-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Sanofi","class":"INDUSTRY"},"collaborators":[{"name":"Hanmi Pharmaceutical Company Limited","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Primary Objective:\n\nTo demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.\n\nSecondary Objectives:\n\nTo demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:\n\n* 3-point MACE.\n* Expanded CV outcome.\n* Composite outcome of new or worsening nephropathy.\n\nTo assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.","detailedDescription":"The study duration per participant was up to approximately 36 months."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":4076,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.","interventionNames":["Drug: Placebo"]},{"label":"Efpeglenatide 4 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.","interventionNames":["Drug: Efpeglenatide (SAR439977)"]},{"label":"Efpeglenatide 6 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.","interventionNames":["Drug: Efpeglenatide (SAR439977)"]}],"interventions":[{"type":"DRUG","name":"Efpeglenatide (SAR439977)","description":"Pharmaceutical form: Solution for injection,\n\nRoute of administration: SC","armGroupLabels":["Efpeglenatide 4 mg","Efpeglenatide 6 mg"]},{"type":"DRUG","name":"Placebo","description":"Pharmaceutical form: Solution for injection\n\nRoute of administration: SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis","description":"All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.","timeFrame":"From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)"}],"secondaryOutcomes":[{"measure":"Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis","description":"All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.","timeFrame":"From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)"},{"measure":"Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event","description":"All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.","timeFrame":"From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)"},{"measure":"Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint","description":"Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (\\>) 300, as measured in mg of albumin to grams of creatinine, or \\>33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m\\^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100\\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.","timeFrame":"From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* T2DM with glycosylated hemoglobin (HbA1c) greater than (\\>) 7 percentage.\n* Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor.\n* Female participants agreed to follow contraceptive guidance.\n* Signed written informed consent.\n\nExclusion criteria:\n\n* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.\n* History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.\n* Personal or family history of medullary thyroid cancer.\n* Hypertension (with a systolic blood pressure \\>180 millimeters of Mercury \\[mmHg\\] and/or diastolic blood pressure \\>100 mmHg).\n* Hospitalization for hypertensive emergency within 3 months prior to randomization.\n* Planned coronary procedure or surgery after randomization.\n* No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.\n* Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.\n* Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.\n* Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.\n* Antihyperglycemic treatment had not been stable within 3 months prior to screening.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Sciences & Operations","affiliation":"Sanofi","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Investigational Site Number 8400032","city":"Sheffield","state":"Alabama","zip":"35660","country":"United States","geoPoint":{"lat":34.76509,"lon":-87.69864}},{"facility":"Investigational Site Number 8400014","city":"Gilbert","state":"Arizona","zip":"85295","country":"United States","geoPoint":{"lat":33.35283,"lon":-111.78903}},{"facility":"Investigational Site Number 8400012","city":"Surprise","state":"Arizona","zip":"85374","country":"United 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Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"36802715","type":"DERIVED","citation":"Gerstein HC, Li Z, Ramasundarahettige C, Baek S, Branch KRH, Del Prato S, Lam CSP, Lopes RD, Pratley R, Rosenstock J, Sattar N. Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial. Circulation. 2023 Mar 28;147(13):1004-1013. doi: 10.1161/CIRCULATIONAHA.122.063716. Epub 2023 Feb 20."},{"pmid":"34775781","type":"DERIVED","citation":"Lam CSP, Ramasundarahettige C, Branch KRH, Sattar N, Rosenstock J, Pratley R, Del Prato S, Lopes RD, Niemoeller E, Khurmi NS, Baek S, Gerstein HC. Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial. Circulation. 2022 Feb 22;145(8):565-574. doi: 10.1161/CIRCULATIONAHA.121.057934. Epub 2021 Nov 14."},{"pmid":"33026143","type":"DERIVED","citation":"Gerstein HC, Branch K, Heenan L, Del Prato S, Khurmi NS, Lam CSP, Pratley R, Rosenstock J, Sattar N. Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist. Diabetes Obes Metab. 2021 Feb;23(2):318-323. doi: 10.1111/dom.14223. Epub 2020 Oct 22."}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Randomization was stratified by the current or potential future use of a sodium-glucose co-transporter-2 (SGLT2) inhibitor: current use; potential future use; neither current nor potential future use.","recruitmentDetails":"The study was conducted at 344 active sites in 28 countries. Overall, 5732 participants were screened between 27 April 2018 and 25 April 2019; of whom 4076 participants were randomized by interactive response technology (1:1:1 ratio) to receive placebo, efpeglenatide 4 milligrams (mg) or efpeglenatide 6 mg. Screen failures were mainly due to inclusion criteria not met.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months)."},{"id":"FG001","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months)."},{"id":"FG002","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","comment":"Randomized.","achievements":[{"groupId":"FG000","numSubjects":"1359"},{"groupId":"FG001","numSubjects":"1359"},{"groupId":"FG002","numSubjects":"1358"}]},{"type":"Randomized and Treated","achievements":[{"groupId":"FG000","numSubjects":"1358"},{"groupId":"FG001","numSubjects":"1358"},{"groupId":"FG002","numSubjects":"1357"}]},{"type":"Safety Population","comment":"Safety population included all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered and were analyzed according to treatment actually received.","achievements":[{"groupId":"FG000","comment":"2 participants of Placebo arm received Efpeglenatide 4 mg treatment and 1 participant received Efpeglenatide 6 mg treatment. Hence, they were counted in the respective arm for safety analysis.","numSubjects":"1355"},{"groupId":"FG001","comment":"2 participants of Placebo arm received Efpeglenatide 4 mg treatment and thus counted in the 4 mg treatment arm for safety analysis.","numSubjects":"1360"},{"groupId":"FG002","comment":"1 participant of Placebo arm received Efpeglenatide 6 mg treatment and thus counted in the 6 mg treatment arm for safety analysis.","numSubjects":"1358"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"36"},{"groupId":"FG002","numSubjects":"23"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1317"},{"groupId":"FG001","numSubjects":"1323"},{"groupId":"FG002","numSubjects":"1335"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"68"},{"groupId":"FG002","numSubjects":"79"}]},{"type":"Study terminated by 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Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100\\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.","populationDescription":"Analysis was performed on ITT population. 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