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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
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 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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
621 Previous Clinical Trials
379,981 Total Patients Enrolled
2 Trials studying Obesity
414 Patients Enrolled for Obesity
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
250,790 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participating in this research trial?

"- At the initial assessment,"

Answered by AI

Are there any available vacancies for potential participants in this research study?

"The ongoing search for eligible participants is detailed on clinicaltrials.gov. This investigation was initially disclosed on March 13, 2024 and recently revised on March 20, 2024."

Answered by AI

What is the level of safety associated with Arm C0 for individuals involved in the trial?

"In this Phase 2 trial, Arm C0's safety was rated a 2 by the team at Power. This indicates some existing data supporting its safety profile but lacking evidence of efficacy."

Answered by AI

Are participants above the age of 40 eligible for enrollment in this research investigation?

"Applicants aged between 18 and 80 years old are eligible for this study. Notably, there is a wealth of clinical studies available specifically for individuals under the age of 18 (178 trials) as well as those over 65 (646 trials)."

Answered by AI

What is the total number of individuals participating in this clinical investigation?

"A total of 624 eligible individuals are sought to partake in this research. Potential participants can engage from various locations, including Tandem Clinical Research in Marrero, Louisiana and Accellacare of Wilmington in Wilmington, North carolina."

Answered by AI

Who else is applying?

What site did they apply to?
Tandem Clinical Research, Marrero
ProSciento
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Gained a lot of weight. Eat healthy, can’t lose it.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Tandem Clinical Research, Marrero: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
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
2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299098.
All > Anaheim > New Orleans
~416 spots leftby Jun 2026
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