protocolSection identificationModule nctId: NCT06299098, orgStudyIdInfo id: R1033-OB-2288, briefTitle: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss, acronym: COURAGE, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-06-24, completionDateStruct date: 2026-06-24, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy.Parts A and B of the study are looking at several other research questions, including:* What side effects may happen from taking the study drug* How much study drug is in the blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects), conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 624, type: ESTIMATED, armsInterventionsModule interventions name: Trevogrumab-Part A, interventions name: Trevogrumab-Part B, interventions name: Garetosmab, interventions name: Semaglutide, interventions name: Matching Placebo-Part A, interventions name: Matching Placebo-Trevogrumab, interventions name: Matching Placebo-Garetosmab, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Severity of TEAEs, primaryOutcomes measure: Percent body weight change, primaryOutcomes measure: Percent change in total fat mass, secondaryOutcomes measure: Concentrations of trevogrumab in serum over time, secondaryOutcomes measure: Percent body weight change, secondaryOutcomes measure: Percent change in total fat mass, secondaryOutcomes measure: Percent change in total lean mass, secondaryOutcomes measure: Change in waist circumference (cm), secondaryOutcomes measure: Percent change in body weight, secondaryOutcomes measure: Percent change in total lean mass, secondaryOutcomes measure: Percent change in regional measurements of body composition, secondaryOutcomes measure: Percent change in gynoid fat mass, secondaryOutcomes measure: Change in total lean mass:total fat mass ratio, secondaryOutcomes measure: Proportion of weight loss attributable to fat mass loss, secondaryOutcomes measure: Percent change in android (central) fat mass, secondaryOutcomes measure: Percent change in thigh muscle volume (TMV), secondaryOutcomes measure: Body weight reduction of ≥5%, secondaryOutcomes measure: Body weight reduction of ≥10%, secondaryOutcomes measure: Body weight reduction of ≥15%, secondaryOutcomes measure: Body weight reduction of ≥20%, secondaryOutcomes measure: Body weight reduction of ≥25%, secondaryOutcomes measure: Percent change in fasting serum triglycerides, secondaryOutcomes measure: Percent change in total cholesterol, secondaryOutcomes measure: Percent change in Apolipoprotein B (Apo B), secondaryOutcomes measure: Percent change in low-density lipoprotein cholesterol (LDL-C), secondaryOutcomes measure: Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT), secondaryOutcomes measure: Change in physical functioning domain score of SF-36, secondaryOutcomes measure: Concentrations of garetosmab in serum over time, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time, secondaryOutcomes measure: Titer of ADAs to trevogrumab after repeated doses over time, secondaryOutcomes measure: Incidence of ADAs to garetosmab after repeated doses over time, secondaryOutcomes measure: Titer of ADAs to garetosmab after repeated doses over time, secondaryOutcomes measure: Incidence of TEAEs, secondaryOutcomes measure: Severity of TEAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ProSciento, city: Chula Vista, state: California, zip: 91911, country: United States, geoPoint lat: 32.64005, lon: -117.0842, locations facility: Tandem Clinical Research, city: Marrero, state: Louisiana, zip: 70072, country: United States, geoPoint lat: 29.89937, lon: -90.10035, locations facility: Accellacare of Wilmington, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, hasResults: False