{"protocolSection":{"identificationModule":{"nctId":"NCT06186622","orgStudyIdInfo":{"id":"18631"},"secondaryIdInfos":[{"id":"J2A-MC-GZPG","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants","officialTitle":"A Drug-Drug Interaction Study to Assess the Effect of Orforglipron on the Pharmacokinetics of Digoxin, Simvastatin, Rosuvastatin, Acetaminophen, and Midazolam in Healthy Overweight and Obese Participants"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-01-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-10","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-10","type":"ACTUAL"},"studyFirstSubmitDate":"2023-12-16","studyFirstSubmitQcDate":"2023-12-16","studyFirstPostDateStruct":{"date":"2024-01-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-29","resultsFirstSubmitQcDate":"2026-04-29","resultsFirstPostDateStruct":{"date":"2026-05-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-29","lastUpdatePostDateStruct":{"date":"2026-05-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and together with orforglipron) that enters the bloodstream and how long it takes the body to eliminate them when administered orally in healthy overweight and obese participants. In addition, the effect of the orforglipron tablet on the amount of simvastatin that enters the bloodstream and how long it takes the body to eliminate it will be evaluated.\n\nThe study will also assess the effect of sodium bicarbonate when administered alone with simvastatin versus orforglipron capsule containing sodium bicarbonate administered with simvastatin. The safety and tolerability of orforglipron and information about any side effects experienced will be collected.\n\nStudy will be conducted in two parts, with part 1 and 2 lasting up to approximately 23 and 24 weeks each, including the screening period."},"conditionsModule":{"conditions":["Healthy","Obese","Overweight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":50,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration","type":"EXPERIMENTAL","description":"Participants received single oral doses as follows:Day 1: 20 milligram(mg) simvastatin; Day 2: 0.25 mg digoxin; Day 7:20 mg simvastatin + 600 mg sodium bicarbonate; Day 8: 20 mg rosuvastatin; Day 10: 1000 mg acetaminophen; Day 12: 0.2 mg midazolam;Day 14: 1 mg Orforglipron, followed by 1000 mg acetaminophen administered 2 hours (±10 minutes) later (staggered); Day 15: 1 mg Orforglipron; Days 16-97: Orforglipron administered once daily with dose escalation every 14 days:1 mg (Days 16-27), 3 mg (Days 28-41),6 mg (Days 42-55),12 mg (Days 56-69),24 mg (Days 70-83),36 mg (Days 84-97).\n\nDays 98-110: 36 mg Orforglipron administered once daily with co administration as follows:Day 98: 20 mg simvastatin (simultaneous); Day 99: 0.25 mg digoxin (simultaneous); Day 104: 20 mg simvastatin (staggered); Day 105:20 mg rosuvastatin (simultaneous); Day 107: 1000 mg acetaminophen (staggered); Day 109:0.2 mg midazolam (simultaneous); Day 111: 20 mg Orforglipron tablet + 20 mg simvastatin (simultaneous).","interventionNames":["Drug: Orforglipron","Drug: Simvastatin","Drug: Digoxin","Drug: Rosuvastatin","Drug: Acetaminophen","Drug: Midazolam","Drug: Sodium Bicarbonate"]},{"label":"Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration","type":"EXPERIMENTAL","description":"Participants received single oral doses as follows: Day 1: 20 mg Simvastatin; Day 2: 0.25 mg Digoxin; Day 7: 20 mg Simvastatin + 600 mg Sodium Bicarbonate; Day 9: 1 mg Orforglipron capsule; Days 10-90: Participants received orforglipron capsule orally QD for 12 weeks, beginning at 1 mg QD. The dose was escalated every 14 days as follows: 1 mg (Days 10-22), 3 mg (Days 23-36), 6 mg (Days 37-50), 12 mg (Days 51-64), 24 mg (Days 65-78), and 36 mg (Days 79-90).\n\nParticipants continued 36 mg Orforglipron QD until Day 100, with co-administration of the following drugs; Day 93: 20 mg Simvastatin (simultaneous); Day 94: 0.25 mg Digoxin (simultaneous); Day 99: 20 mg Simvastatin administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing); Day 101: 20 mg Orforglipron tablet + 20 mg Simvastatin (simultaneous)","interventionNames":["Drug: Orforglipron","Drug: Simvastatin","Drug: Digoxin","Drug: Sodium Bicarbonate"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration","Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration"],"otherNames":["LY3502970"]},{"type":"DRUG","name":"Simvastatin","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration","Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration"]},{"type":"DRUG","name":"Digoxin","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration","Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration"]},{"type":"DRUG","name":"Rosuvastatin","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration"]},{"type":"DRUG","name":"Acetaminophen","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration"]},{"type":"DRUG","name":"Midazolam","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration"]},{"type":"DRUG","name":"Sodium Bicarbonate","description":"Administered orally.","armGroupLabels":["Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration","Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Simvastatin and Its Metabolite Simvastatin Acid Following Simultaneous Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours (h) post-dose; Day 98 (Cohort 1) and Day 93 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following staggered administration with or without Orforglipron capsule were reported in this outcome measure. Simvastatin was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 104 (Cohort 1) and Day 99 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without sodium bicarbonate administration were reported in this outcome measure.","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 7 (Cohort 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: AUC [0-∞] of Digoxin (Cohort 1 and 2)","timeFrame":"Day 2 (For Cohort 1 and 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose ; Day 99 (Cohort 1) and Day 94 (Cohort 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose"},{"measure":"PK: AUC [0-∞] of Rosuvastatin (Cohort 1 Only)","timeFrame":"Day 8 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose; Day 105 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose"},{"measure":"PK: AUC [0-∞] of Acetaminophen (Cohort 1 Only)","description":"AUC \\[0-∞\\] of acetaminophen following staggered administration with or without either 1 mg or 36 mg Orforglipron capsule were reported in this outcome measure. Acetaminophen was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","timeFrame":"Day 10 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 14 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 107 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose"},{"measure":"PK: AUC [0-∞] of Midazolam and Its Metabolite 1'-Hydroxymidazolam (Cohort 1 Only)","description":"AUC \\[0-∞\\] of midazolam and its metabolite (1'-Hydroxymidazolam) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.","timeFrame":"Day 12 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose; Day 109 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose"},{"measure":"PK: Maximum Observed Concentration (Cmax) of Simvastatin and Its Metabolite Simvastatin Acid Following Simultaneous Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 98 (Cohort 1) and Day 93 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following staggered administration with or without Orforglipron capsule were reported in this outcome measure. Simvastatin was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 104 (Cohort 1) and Day 99 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without sodium bicarbonate administration were reported in this outcome measure.","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 7 (Cohort 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: Cmax of Digoxin (Cohorts 1 and 2)","timeFrame":"Day 2 (For Cohort 1 and 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose; Day 99 (Cohort 1) and Day 94 (Cohort 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose"},{"measure":"PK: Cmax of Rosuvastatin (Cohort 1 Only)","timeFrame":"Day 8 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose; Day 105 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose"},{"measure":"PK: Cmax of Acetaminophen (Cohort 1 Only)","description":"Cmax of acetaminophen following staggered administration with or without either 1 mg or 36 mg Orforglipron capsule were reported in this outcome measure. Acetaminophen was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","timeFrame":"Day 10 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 14 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 107 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose"},{"measure":"PK: Cmax of Midazolam and Its Metabolite 1'-Hydroxymidazolam (Cohort 1 Only)","description":"Cmax of Midazolam and its metabolite (1'-Hydroxymidazolam) following simultaneous administration with or without Orforglipron capsule is reported in this outcome measure.","timeFrame":"Day 12 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose; Day 109 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose"}],"secondaryOutcomes":[{"measure":"PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron tablet were reported in this outcome measure.","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 111 (Cohort 1) and Day 101 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"},{"measure":"PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron tablet were reported in this outcome measure.","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 111 (Cohort 1) and Day 101 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical history and physical examination.\n* Have body mass index (BMI) equal to or greater than 27 kilograms per meter squared (kg/m²), inclusive, at screening.\n* Have an estimated glomerular filtration rate equal to or greater than 60 milliliters per minute (mL/min).\n* Males and females who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).\n* Have venous access sufficient to allow for blood sampling.\n\nExclusion Criteria:\n\n* Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.\n* Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years.\n* Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.\n* Have known clinically significant gastric emptying abnormality.\n* Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)\n* Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.\n* Have an abnormal 12-lead electrocardiogram (ECG) at screening.\n* Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug.\n* Participants must not be currently participating in or completed a clinical trial within the last 90 days.\n* Have a known allergy or hypersensitivity to midazolam, simvastatin, rosuvastatin, or digoxin.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Fortrea Clinical Research Unit Inc.","city":"Daytona Beach","state":"Florida","zip":"32117","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}},{"facility":"Fortrea Clinical Research Unit Inc.","city":"Dallas","state":"Texas","zip":"75247","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration","description":"Participants received single oral doses of the following drugs:\n\n* Day 1: 20 milligram (mg) Simvastatin alone\n* Day 2: 0.25 mg Digoxin alone\n* Day 7: 20 mg Simvastatin + 600 mg Sodium Bicarbonate\n* Day 8: 20 mg Rosuvastatin alone\n* Day 10: 1000 mg Acetaminophen alone\n* Day 12: 0.2 mg Midazolam alone\n* Day 14: 1 mg Orforglipron capsule + 1000 mg Acetaminophen administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 15: 1 mg Orforglipron capsule\n* Days 16-97: Participants received Orforglipron capsule orally once daily (QD) for 12 weeks, beginning at 1 mg QD. The dose was escalated every 14 days as follows: 1 mg (Days 16-27), 3 mg (Days 28-41), 6 mg (Days 42-55), 12 mg (Days 56-69), 24 mg (Days 70-83), and 36 mg (Days 84-97).\n\nParticipants continued 36 mg Orforglipron QD until Day 110, with co-administration of the following drugs:\n\n* Day 98: 20 mg Simvastatin (simultaneous dosing)\n* Day 99: 0.25 mg Digoxin (simultaneous dosing)\n* Day 104: 20 mg Simvastatin administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 105: 20 mg Rosuvastatin (simultaneous dosing)\n* Day 107: 1000 mg Acetaminophen administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 109: 0.2 mg Midazolam (simultaneous dosing)\n* Day 111: 20 mg Orforglipron tablet + 20 mg Simvastatin (simultaneous dosing)"},{"id":"FG001","title":"Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration","description":"Participants received single oral doses of the following drugs:\n\n* Day 1: 20 milligram (mg) Simvastatin alone\n* Day 2: 0.25 mg Digoxin alone\n* Day 7: 20 mg Simvastatin + 600 mg Sodium Bicarbonate\n* Day 9: 1 mg Orforglipron capsule\n* Days 10-90: Participants received orforglipron capsule orally QD for 12 weeks, beginning at 1 mg QD. The dose was escalated every 14 days as follows: 1 mg (Days 10-22), 3 mg (Days 23-36), 6 mg (Days 37-50), 12 mg (Days 51-64), 24 mg (Days 65-78), and 36 mg (Days 79-90).\n\nParticipants continued 36 mg Orforglipron QD until Day 100, with co-administration of the following drugs:\n\n* Day 93: 20 mg Simvastatin (simultaneous dosing)\n* Day 94: 0.25 mg Digoxin (simultaneous dosing)\n* Day 99: 20 mg Simvastatin administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 101: 20 mg Orforglipron tablet + 20 mg Simvastatin (simultaneous dosing)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"Safety Analysis Population (Received at Least One Dose of Study Drug)","achievements":[{"groupId":"FG000","comment":"In Cohort 1, 30 participants started on Days 1-2 (n=30). Discontinuations occurred as follows: 2 after digoxin (Day 2; n=28), 1 after rosuvastatin (Day 8; n=27), 1 after 1 mg orforglipron (Day 27; n=26), and 4 during 36 mg orforglipron dosing (Days 93-97; n=22). Of the 22 remaining participants in the co-administration period (Days 98-111), 1 did not receive orforglipron or midazolam on Day 109 due to intolerability (n=21) but resumed dosing on Day 110 per protocol.","numSubjects":"30"},{"groupId":"FG001","comment":"In Cohort 2, 20 participants were included during Days 1-36 (n=20). After 1 discontinuation on Day 34 following 3 mg Orforglipron administration, 19 participants remained during Days 37-64 (n=19). One participant discontinued on Day 57 after 12 mg orforglipron, leaving 18 participants during Days 65-92 (n=18). Two participants discontinued on Day 90 after 36 mg Orforglipron, leaving 16 participants during Days 93-101 (n=16).","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled population.","groups":[{"id":"BG000","title":"Cohort 1: Oral Drug Dosing With or Without Orforglipron","description":"Participants received single oral doses of the following drugs:\n\n* Day 1: 20 milligram (mg) Simvastatin alone\n* Day 2: 0.25 mg Digoxin alone\n* Day 7: 20 mg Simvastatin + 600 mg Sodium Bicarbonate\n* Day 8: 20 mg Rosuvastatin alone\n* Day 10: 1000 mg Acetaminophen alone\n* Day 12: 0.2 mg Midazolam alone\n* Day 14: 1 mg Orforglipron capsule + 1000 mg Acetaminophen administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 15: 1 mg Orforglipron capsule\n* Days 16-97: Participants received Orforglipron capsule orally once daily (QD) for 12 weeks, beginning at 1 mg QD. The dose was escalated every 14 days as follows: 1 mg (Days 16-27), 3 mg (Days 28-41), 6 mg (Days 42-55), 12 mg (Days 56-69), 24 mg (Days 70-83), and 36 mg (Days 84-97).\n\nParticipants continued 36 mg Orforglipron QD until Day 110, with co-administration of the following drugs:\n\n* Day 98: 20 mg Simvastatin (simultaneous dosing)\n* Day 99: 0.25 mg Digoxin (simultaneous dosing)\n* Day 104: 20 mg Simvastatin administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 105: 20 mg Rosuvastatin (simultaneous dosing)\n* Day 107: 1000 mg Acetaminophen administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 109: 0.2 mg Midazolam (simultaneous dosing)\n* Day 111: 20 mg Orforglipron tablet + 20 mg Simvastatin (simultaneous dosing)"},{"id":"BG001","title":"Cohort 2: Oral Drug Dosing With or Without Orforglipron","description":"Participants received single oral doses of the following drugs:\n\n* Day 1: 20 mg Simvastatin alone\n* Day 2: 0.25 mg Digoxin alone\n* Day 7: 20 mg Simvastatin + 600 mg Sodium Bicarbonate\n* Day 9: 1 mg Orforglipron capsule\n* Days 10-90: Participants received Orforglipron capsule orally QD for 12 weeks, beginning at 1 mg QD. The dose was escalated every 14 days as follows: 1 mg (Days 10-22), 3 mg (Days 23-36), 6 mg (Days 37-50), 12 mg (Days 51-64), 24 mg (Days 65-78), and 36 mg (Days 79-90).\n\nParticipants continued 36 mg Orforglipron QD until Day 100, with co-administration of the following drugs:\n\n* Day 93: 20 mg Simvastatin (simultaneous dosing)\n* Day 94: 0.25 mg Digoxin (simultaneous dosing)\n* Day 99: 20 mg Simvastatin administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing)\n* Day 101: 20 mg Orforglipron tablet + 20 mg Simvastatin (simultaneous dosing)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"50"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.5","spread":"12.80"},{"groupId":"BG001","value":"42.9","spread":"12.17"},{"groupId":"BG002","value":"44.4","spread":"12.49"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"34"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"16"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"19"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"31"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"13"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"35"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"50"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Simvastatin and Its Metabolite Simvastatin Acid Following Simultaneous Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data for this specific outcome. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram* hours per milliliter (ng*h/ml)","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours (h) post-dose; Day 98 (Cohort 1) and Day 93 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohorts 1 and 2)."},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin","description":"Participants received simultaneous dosing of 20 mg simvastatin and 36 mg Orforglipron capsule orally on Day 98 (Cohort 1) and Day 93 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"36"}]}],"classes":[{"title":"Simvastatin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"36"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.1","spread":"79.2"},{"groupId":"OG001","value":"18.8","spread":"84.3"}]}]},{"title":"Metabolite- Simvastatin Acid","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"33"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.6","spread":"79.7"},{"groupId":"OG001","value":"23.3","spread":"74.2"}]}]}]},{"type":"PRIMARY","title":"PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following staggered administration with or without Orforglipron capsule were reported in this outcome measure. Simvastatin was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 104 (Cohort 1) and Day 99 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohorts 1 and 2)"},{"id":"OG001","title":"Staggered 36 mg Orforglipron Capsule + 20 mg Simvastatin","description":"Participants received staggered dosing of 36 mg Orforglipron capsule followed by 20 mg Simvastatin orally on Day 104 (Cohort 1) and Day 99 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"title":"Simvastatin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.1","spread":"79.2"},{"groupId":"OG001","value":"20.1","spread":"76.5"}]}]},{"title":"Metabolite- Simvastatin Acid","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"34"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.6","spread":"79.7"},{"groupId":"OG001","value":"30.2","spread":"70.3"}]}]}]},{"type":"PRIMARY","title":"PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without sodium bicarbonate administration were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data for this specific outcome. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 7 (Cohort 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohorts 1 and 2)."},{"id":"OG001","title":"20 mg Simultaneous Simvastatin + 600 mg Sodium Bicarbonate","description":"Participants received simultaneous dosing of 20 mg simvastatin and 600 mg sodium bicarbonate orally on Day 7 (Cohorts 1 and 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"47"}]}],"classes":[{"title":"Simvastatin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"47"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.1","spread":"79.2"},{"groupId":"OG001","value":"20.3","spread":"82.8"}]}]},{"title":"Metabolite- Simvastatin Acid","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.6","spread":"79.7"},{"groupId":"OG001","value":"14.0","spread":"61.3"}]}]}]},{"type":"PRIMARY","title":"PK: AUC [0-∞] of Digoxin (Cohort 1 and 2)","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data for this specific outcome. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 2 (For Cohort 1 and 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose ; Day 99 (Cohort 1) and Day 94 (Cohort 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose","groups":[{"id":"OG000","title":"0.25 mg Digoxin Alone","description":"Participants received 0.25 mg digoxin alone on Day 2 (Cohort 1 and 2)."},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin","description":"Participants received simultaneous dosing of 0.25 mg digoxin and 36 mg Orforglipron capsule orally on Day 99 (Cohort 1) and Day 94 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.8","spread":"21.5"},{"groupId":"OG001","value":"22.4","spread":"26.5"}]}]}]},{"type":"PRIMARY","title":"PK: AUC [0-∞] of Rosuvastatin (Cohort 1 Only)","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 8 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose; Day 105 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose","groups":[{"id":"OG000","title":"20 mg Rosuvastatin Alone","description":"Participants received single dose of 20 mg rosuvastatin alone orally on Day 8 (Cohort 1 only)."},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin","description":"Participants received simultaneous dosing of 20 mg rosuvastatin and 36 mg Orforglipron capsule orally on Day 105 (Cohort 1 only)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"116","spread":"52.1"},{"groupId":"OG001","value":"192","spread":"60.1"}]}]}]},{"type":"PRIMARY","title":"PK: AUC [0-∞] of Acetaminophen (Cohort 1 Only)","description":"AUC \\[0-∞\\] of acetaminophen following staggered administration with or without either 1 mg or 36 mg Orforglipron capsule were reported in this outcome measure. Acetaminophen was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 10 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 14 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 107 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose","groups":[{"id":"OG000","title":"1000 mg Acetaminophen Alone","description":"Participants received single dose of 1000 mg acetaminophen alone orally on Day 10 (Cohort 1 only)."},{"id":"OG001","title":"Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen","description":"Participants received staggered dosing of 1 mg single dose of Orforglipron capsule followed by 1000 mg acetaminophen orally on Day 14 (Cohort 1 only)."},{"id":"OG002","title":"Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen","description":"Participants received staggered dosing of 36 mg single dose of Orforglipron capsule followed by 1000 mg acetaminophen orally on Day 107 (Cohort 1 Only)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"59900","spread":"37.2"},{"groupId":"OG001","value":"52900","spread":"39.0"},{"groupId":"OG002","value":"73000","spread":"64.3"}]}]}]},{"type":"PRIMARY","title":"PK: AUC [0-∞] of Midazolam and Its Metabolite 1'-Hydroxymidazolam (Cohort 1 Only)","description":"AUC \\[0-∞\\] of midazolam and its metabolite (1'-Hydroxymidazolam) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 12 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose; Day 109 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose","groups":[{"id":"OG000","title":"0.2 mg Midazolam Alone","description":"Participants received single dose of 0.2 mg midazolam alone orally on Day 12 (Cohort 1 only)"},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 0.2 mg Midazolam","description":"Participants received simultaneous dosing of 0.2 mg midazolam and 36 mg Orforglipron capsule orally on Day 109 (Cohort 1 Only)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"21"}]}],"classes":[{"title":"Midazolam","categories":[{"measurements":[{"groupId":"OG000","value":"3.82","spread":"41.2"},{"groupId":"OG001","value":"4.60","spread":"47.3"}]}]},{"title":"Metabolite- 1'-Hydroxymidazolam","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"43.2"},{"groupId":"OG001","value":"1.34","spread":"48.5"}]}]}]},{"type":"PRIMARY","title":"PK: Maximum Observed Concentration (Cmax) of Simvastatin and Its Metabolite Simvastatin Acid Following Simultaneous Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram per milliliter (ng/ml)","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 98 (Cohort 1) and Day 93 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohort 1 and 2)"},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin","description":"Participants received simultaneous dosing of 20 mg simvastatin and 36 mg Orforglipron capsule orally on Day 98 (Cohort 1) and Day 93 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"title":"Simvastatin","categories":[{"measurements":[{"groupId":"OG000","value":"4.68","spread":"80.3"},{"groupId":"OG001","value":"4.07","spread":"89.1"}]}]},{"title":"Metabolite-Simvastatin Acid","categories":[{"measurements":[{"groupId":"OG000","value":"1.25","spread":"74.6"},{"groupId":"OG001","value":"2.72","spread":"84.8"}]}]}]},{"type":"PRIMARY","title":"PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following staggered administration with or without Orforglipron capsule were reported in this outcome measure. Simvastatin was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 104 (Cohort 1) and Day 99 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohort 1 and 2)."},{"id":"OG001","title":"Staggered 36 mg Orforglipron Capsule + 20 mg Simvastatin","description":"Participants received staggered dosing of 36 mg Orforglipron capsule followed by 20 mg Simvastatin orally on Day 104 (Cohort 1) and Day 99 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"title":"Simvastatin","categories":[{"measurements":[{"groupId":"OG000","value":"4.68","spread":"80.3"},{"groupId":"OG001","value":"3.34","spread":"82.7"}]}]},{"title":"Metabolite- Simvastatin Acid","categories":[{"measurements":[{"groupId":"OG000","value":"1.25","spread":"74.6"},{"groupId":"OG001","value":"2.94","spread":"70.2"}]}]}]},{"type":"PRIMARY","title":"PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without sodium bicarbonate administration were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 7 (Cohort 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohort 1 and 2)."},{"id":"OG001","title":"20 mg Simultaneous Simvastatin + 600 mg Sodium Bicarbonate","description":"Participants received simultaneous dosing of 20 mg simvastatin and 600 mg sodium bicarbonate orally on Day 7 (Cohorts 1 and 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"50"}]}],"classes":[{"title":"Simvastatin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.68","spread":"80.3"},{"groupId":"OG001","value":"4.62","spread":"69.0"}]}]},{"title":"Metabolite- Simvastatin Acid","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.25","spread":"74.6"},{"groupId":"OG001","value":"1.23","spread":"67.2"}]}]}]},{"type":"PRIMARY","title":"PK: Cmax of Digoxin (Cohorts 1 and 2)","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 2 (For Cohort 1 and 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose; Day 99 (Cohort 1) and Day 94 (Cohort 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose","groups":[{"id":"OG000","title":"0.25 mg Digoxin Alone","description":"Participants received 0.25 mg digoxin alone on Day 2 (Cohort 1 and 2)."},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin","description":"Participants received simultaneous dosing of 0.25 mg digoxin and 36 mg Orforglipron capsule orally on Day 99 (Cohort 1) and Day 94 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"26.1"},{"groupId":"OG001","value":"1.20","spread":"46.1"}]}]}]},{"type":"PRIMARY","title":"PK: Cmax of Rosuvastatin (Cohort 1 Only)","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 8 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose; Day 105 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose","groups":[{"id":"OG000","title":"20 mg Rosuvastatin Alone","description":"Participants received single dose of 20 mg rosuvastatin alone orally on Day 8 (Cohort 1 only)."},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin","description":"Participants received simultaneous dosing of 20 mg rosuvastatin and 36 mg Orforglipron capsule orally on Day 105 (Cohort 1 only)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.4","spread":"69.8"},{"groupId":"OG001","value":"14.2","spread":"83.3"}]}]}]},{"type":"PRIMARY","title":"PK: Cmax of Acetaminophen (Cohort 1 Only)","description":"Cmax of acetaminophen following staggered administration with or without either 1 mg or 36 mg Orforglipron capsule were reported in this outcome measure. Acetaminophen was administered \\~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 10 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 14 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 107 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose","groups":[{"id":"OG000","title":"1000 mg Acetaminophen Alone","description":"Participants received single dose of 1000 mg acetaminophen alone orally on Day 10 (Cohort 1 only)"},{"id":"OG001","title":"Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen","description":"Participants received staggered dosing of 1 mg single dose of Orforglipron capsule followed by 1000 mg acetaminophen orally on Day 14 (Cohort 1 only)."},{"id":"OG002","title":"Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen","description":"Participants received staggered dosing of 36 mg single dose of Orforglipron capsule followed by 1000 mg acetaminophen orally on Day 107 (Cohort 1 only)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10800","spread":"29.5"},{"groupId":"OG001","value":"7760","spread":"42.2"},{"groupId":"OG002","value":"10800","spread":"57.7"}]}]}]},{"type":"PRIMARY","title":"PK: Cmax of Midazolam and Its Metabolite 1'-Hydroxymidazolam (Cohort 1 Only)","description":"Cmax of Midazolam and its metabolite (1'-Hydroxymidazolam) following simultaneous administration with or without Orforglipron capsule is reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 12 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose; Day 109 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose","groups":[{"id":"OG000","title":"0.2 mg Midazolam Alone","description":"Participants received single dose of 0.2 mg midazolam alone orally on Day 12 (Cohort 1 only)."},{"id":"OG001","title":"Simultaneous 36 mg Orforglipron Capsule + 0.2 mg Midazolam","description":"Participants received simultaneous dosing of 0.2 mg midazolam and 36 mg Orforglipron capsule orally on Day 109 (Cohort 1 only)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"21"}]}],"classes":[{"title":"Midazolam","categories":[{"measurements":[{"groupId":"OG000","value":"1.23","spread":"36.1"},{"groupId":"OG001","value":"1.33","spread":"43.8"}]}]},{"title":"Metabolite- 1'-Hydroxymidazolam","categories":[{"measurements":[{"groupId":"OG000","value":"0.331","spread":"46.8"},{"groupId":"OG001","value":"0.357","spread":"54.6"}]}]}]},{"type":"SECONDARY","title":"PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2)","description":"AUC \\[0-∞\\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron tablet were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*h/ml","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 111 (Cohort 1) and Day 101 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohorts 1 and 2)."},{"id":"OG001","title":"Simultaneous 20 mg Orforglipron Tablet + 20 mg Simvastatin","description":"Participants received simultaneous dosing of 20 mg simvastatin and 20 mg Orforglipron tablet orally on Day 111 (Cohort 1) and Day 101 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"title":"Simvastatin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.1","spread":"79.2"},{"groupId":"OG001","value":"21.0","spread":"82.2"}]}]},{"title":"Metabolite- Simvastatin Acid","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"34"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.6","spread":"79.7"},{"groupId":"OG001","value":"29.3","spread":"72.0"}]}]}]},{"type":"SECONDARY","title":"PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2)","description":"Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron tablet were reported in this outcome measure.","populationDescription":"All participants who received at least 1 dose of study drug and had evaluable PK data. As pre-specified in Statistical Analysis Plan, participants were analyzed according to the treatment regimen they received. Data from Cohorts 1 and 2 were combined, and the pooled results are presented for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/ml","timeFrame":"Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 111 (Cohort 1) and Day 101 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose","groups":[{"id":"OG000","title":"20 mg Simvastatin Alone","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1 (Cohorts 1 and 2)."},{"id":"OG001","title":"Simultaneous 20 mg Orforglipron Tablet + 20 mg Simvastatin","description":"Participants received simultaneous dosing of 20 mg simvastatin and 20 mg Orforglipron tablet orally on Day 111 (Cohort 1) and Day 101 (Cohort 2)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"37"}]}],"classes":[{"title":"Simvastatin","categories":[{"measurements":[{"groupId":"OG000","value":"4.68","spread":"80.3"},{"groupId":"OG001","value":"3.78","spread":"73.6"}]}]},{"title":"Metabolite- Simvastatin Acid","categories":[{"measurements":[{"groupId":"OG000","value":"1.25","spread":"74.6"},{"groupId":"OG001","value":"3.00","spread":"67.9"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Cohort 1: Baseline up to end of follow-up (up to 129 days); Cohort 2: Baseline up to end of follow-up (up to 119 days)","description":"All participants who received at least 1 dose of study drug (Orforglipron, Simvastatin, Digoxin, Rosuvastatin, Acetaminophen, and Midazolam). Participants were analyzed according to the treatment regimen they received.","eventGroups":[{"id":"EG000","title":"Cohort 1: 20 mg Simvastatin Alone (Day 1)","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1.","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":2,"otherNumAtRisk":30},{"id":"EG001","title":"Cohort 1: 0.25 mg Digoxin Alone (Day 2)","description":"Participants received 0.25 mg digoxin alone on Day 2.","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":0,"otherNumAtRisk":30},{"id":"EG002","title":"Cohort 1: 20 mg Simvastatin + 600 mg Sodium Bicarbonate (Day 7)","description":"Participants received simultaneous dosing of 20 mg simvastatin and 600 mg sodium bicarbonate orally on Day 7.","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":0,"otherNumAtRisk":28},{"id":"EG003","title":"Cohort 1: 20 mg Rosuvastatin Alone (Day 8)","description":"Participants received single dose of 20 mg rosuvastatin alone orally on Day 8.","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":0,"otherNumAtRisk":28},{"id":"EG004","title":"Cohort 1: 1000 mg Acetaminophen Alone (Day 10)","description":"Participants received single dose of 1000 mg acetaminophen alone orally on Day 10.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":1,"otherNumAtRisk":27},{"id":"EG005","title":"Cohort 1: 0.2 mg Midazolam Alone (Day 12)","description":"Participants received single dose of 0.2 mg midazolam alone orally on Day 12.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":0,"otherNumAtRisk":27},{"id":"EG006","title":"Cohort 1: Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen (Day 14)","description":"Participants received staggered dosing of 1 mg single dose of Orforglipron followed by 1000 mg acetaminophen orally on Day 14.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":1,"otherNumAtRisk":27},{"id":"EG007","title":"Cohort 1: 1 mg Orforglipron Capsule QD (Day 15 to Day 27)","description":"Participants received 1 mg Orforglipron capsule once daily from Day 15 through Day 27.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":4,"otherNumAtRisk":27},{"id":"EG008","title":"Cohort 1: 3 mg Orforglipron Capsule QD (Day 28 to Day 41)","description":"Participants received 3 mg Orforglipron capsule once daily from Day 28 through Day 41.","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":2,"otherNumAtRisk":26},{"id":"EG009","title":"Cohort 1: 6 mg Orforglipron Capsule QD (Day 42 to Day 55)","description":"Participants received 6 mg Orforglipron capsule once daily from Day 42 through Day 55.","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":5,"otherNumAtRisk":26},{"id":"EG010","title":"Cohort 1: 12 mg Orforglipron Capsule QD (Day 56 to Day 69)","description":"Participants received 12 mg Orforglipron capsule once daily from Day 56 through Day 69.","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":2,"otherNumAtRisk":26},{"id":"EG011","title":"Cohort 1: 24 mg Orforglipron Capsule QD (Day 70 to Day 83)","description":"Participants received 24 mg Orforglipron capsule once daily from Day 70 through Day 83.","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":2,"otherNumAtRisk":26},{"id":"EG012","title":"Cohort 1: 36 mg Orforglipron Capsule QD (Day 84 to Day 97)","description":"Participants received 36 mg Orforglipron capsule once daily from Day 84 through Day 97.","deathsNumAffected":0,"deathsNumAtRisk":26,"seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":11,"otherNumAtRisk":26},{"id":"EG013","title":"Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 98)","description":"Participants received simultaneous dosing of 20 mg simvastatin and 36 mg Orforglipron orally on Day 98.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":0,"otherNumAtRisk":22},{"id":"EG014","title":"Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin (Day 99)","description":"Participants received simultaneous dosing of 0.25 mg digoxin and 36 mg Orforglipron orally on Day 99.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":2,"otherNumAtRisk":22},{"id":"EG015","title":"Cohort 1: 36 mg Orforglipron Capsule QD (Day 100 to Day 103)","description":"Participants received 36 mg Orforglipron capsule once daily from Day 100 through Day 103.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":2,"otherNumAtRisk":22},{"id":"EG016","title":"Cohort 1: Staggered 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 104)","description":"Participants received staggered dosing of 36 mg Orforglipron followed by 20 mg Simvastatin orally on Day 104.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":0,"otherNumAtRisk":22},{"id":"EG017","title":"Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin (Day 105)","description":"Participants received simultaneous dosing of 20 mg rosuvastatin and 36 mg Orforglipron orally on Day 105.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":2,"otherNumAtRisk":22},{"id":"EG018","title":"Cohort 1: 36 mg Orforglipron Capsule (Day 106)","description":"Participants received 36 mg Orforglipron orally on Day 106.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":2,"otherNumAtRisk":22},{"id":"EG019","title":"Cohort 1: Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen (Day 107)","description":"Participants received staggered dosing of 36 mg Orforglipron capsule followed by 1000 mg acetaminophen orally on Day 107.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":1,"otherNumAtRisk":22},{"id":"EG020","title":"Cohort 1: 36 mg Orforglipron Capsule (Day 108)","description":"Participants received 36 mg Orforglipron orally on Day 108.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":1,"otherNumAtRisk":22},{"id":"EG021","title":"Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 0.2 mg Midazolam (Day 109)","description":"Participants received simultaneous dosing of 0.2 mg midazolam and 36 mg Orforglipron orally on Day 109.","deathsNumAffected":0,"deathsNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":1,"otherNumAtRisk":21},{"id":"EG022","title":"Cohort 1: 36 mg Orforglipron Capsule (Day 110)","description":"Participants received 36 mg Orforglipron orally on Day 110.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":0,"otherNumAtRisk":22},{"id":"EG023","title":"Cohort 1: Simultaneous 20 mg Orforglipron Tablet + 20 mg Simvastatin (Day 111)","description":"Participants received simultaneous dosing of 20 mg simvastatin and 20 mg Orforglipron orally on Day 111.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":2,"otherNumAtRisk":22},{"id":"EG024","title":"Cohort 2: 20 mg Simvastatin Alone (Day 1)","description":"Participants received single dose of 20 mg simvastatin alone orally on Day 1.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":1,"otherNumAtRisk":20},{"id":"EG025","title":"Cohort 2: 0.25 mg Digoxin Alone (Day 2)","description":"Participants received 0.25 mg digoxin alone on Day 2.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":0,"otherNumAtRisk":20},{"id":"EG026","title":"Cohort 2: Simultaneous 20 mg Simvastatin + 600 mg Sodium Bicarbonate (Day 7)","description":"Participants received simultaneous dosing of 20 mg simvastatin and 600 mg sodium bicarbonate orally on Day 7.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":0,"otherNumAtRisk":20},{"id":"EG027","title":"Cohort 2: 1 mg Orforglipron Capsule QD (Day 9 to Day 22)","description":"Participants received 1 mg Orforglipron capsule once daily from Day 9 through Day 22.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":9,"otherNumAtRisk":20},{"id":"EG028","title":"Cohort 2: 3 mg Orforglipron Capsule QD (Day 23 to Day 36)","description":"Participants received 3 mg Orforglipron capsule once daily from Day 23 through Day 36.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":7,"otherNumAtRisk":20},{"id":"EG029","title":"Cohort 2: 6 mg Orforglipron Capsule QD (Day 37 to Day 50)","description":"Participants received 6 mg Orforglipron capsule once daily from Day 37 through Day 50.","deathsNumAffected":0,"deathsNumAtRisk":19,"seriousNumAffected":0,"seriousNumAtRisk":19,"otherNumAffected":6,"otherNumAtRisk":19},{"id":"EG030","title":"Cohort 2: 12 mg Orforglipron Capsule QD (Day 51 to Day 64)","description":"Participants received 12 mg Orforglipron capsule once daily from Day 51 through Day 64.","deathsNumAffected":0,"deathsNumAtRisk":19,"seriousNumAffected":1,"seriousNumAtRisk":19,"otherNumAffected":6,"otherNumAtRisk":19},{"id":"EG031","title":"Cohort 2: 24 mg Orforglipron Capsule QD (Day 65 to Day 78)","description":"Participants received 24 mg Orforglipron capsule once daily from Day 65 through Day 78.","deathsNumAffected":0,"deathsNumAtRisk":18,"seriousNumAffected":0,"seriousNumAtRisk":18,"otherNumAffected":4,"otherNumAtRisk":18},{"id":"EG032","title":"Cohort 2: 36 mg Orforglipron Capsule QD (Day 79 to Day 92)","description":"Participants received 36 mg Orforglipron capsule once daily from Day79 through Day 92.","deathsNumAffected":0,"deathsNumAtRisk":18,"seriousNumAffected":0,"seriousNumAtRisk":18,"otherNumAffected":10,"otherNumAtRisk":18},{"id":"EG033","title":"Cohort 2: Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 93)","description":"Participants received simultaneous dosing of 20 mg simvastatin and 36 mg Orforglipron orally on Day 93.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":1,"otherNumAtRisk":16},{"id":"EG034","title":"Cohort 2: Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin (Day 94)","description":"Participants received simultaneous dosing of 0.25 mg digoxin and 36 mg Orforglipron orally on Day 94.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":1,"otherNumAtRisk":16},{"id":"EG035","title":"Cohort 2: 36 mg Orforglipron Capsule QD (Day 95 to Day 98)","description":"Participants received 36 mg Orforglipron capsule once daily from 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