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Monoclonal Antibodies

Arm C1 for Obesity (COURAGE Trial)

Verified Trial
Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You have been diagnosed with Nonalcoholic Steatohepatitis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 75 weeks
Awards & highlights

COURAGE Trial Summary

This trial is testing two new drugs, trevogrumab and garetosmab, along with a drug called semaglutide (Wegovy®), in both healthy participants and

Who is the study for?
This trial is for adults aged 18-55 with a BMI of 18-32 (Part A), and those aged 18-80 with obesity, defined as a BMI over 30 (Part B). Participants should have tried to lose weight unsuccessfully before. It's not clear what excludes someone from joining.Check my eligibility
What is being tested?
The study tests trevogrumab alone or combined with garetosmab and semaglutide in two parts: Part A focuses on safety in healthy individuals; Part B examines effectiveness for weight loss in obese participants using various drug combinations.See study design
What are the potential side effects?
Potential side effects include reactions to the drugs such as allergies, possible development of antibodies against the drugs reducing their effectiveness, and other unspecified side effects that will be monitored.

COURAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

COURAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 75 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 75 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Body weight reduction of ≥10%
Body weight reduction of ≥15%
Body weight reduction of ≥20%
+27 more

COURAGE Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: TrevogrumabExperimental Treatment1 Intervention
Part A Randomized 1:1
Group II: Arm D1Experimental Treatment3 Interventions
Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Group III: Arm D0Experimental Treatment4 Interventions
Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Group IV: Arm C1Experimental Treatment3 Interventions
Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Group V: Arm C0Experimental Treatment4 Interventions
Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Group VI: Arm B1Experimental Treatment3 Interventions
Part B Sema, low dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Group VII: Arm B0Experimental Treatment4 Interventions
Part B Sema, low dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Group VIII: Arm A1Experimental Treatment4 Interventions
Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Group IX: Arm A0Experimental Treatment3 Interventions
Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Group X: PlaceboPlacebo Group1 Intervention
Part A Randomized 1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
628 Previous Clinical Trials
381,618 Total Patients Enrolled
2 Trials studying Obesity
414 Patients Enrolled for Obesity
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
266 Previous Clinical Trials
251,688 Total Patients Enrolled
~416 spots leftby Jun 2026
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