NCT06299098: COURAGE

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, Fat Loss, and Lean Mass Preservation

Active, enrolled Phase 2 Last updated 17 December 2025

What this trial tests

Phase 2 trial testing Trevogrumab-Part A in Obesity in 1,005 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 March 2024

Primary endpoint
18 May 2026

30 October 2026

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	1,005
Start date	13 March 2024
Primary completion	18 May 2026
Estimated completion	30 October 2026
Sites	60 locations across United States, Puerto Rico

Drugs / interventions tested

• Trevogrumab-Part A
• Trevogrumab-Part B and Part C
• Garetosmab
• Semaglutide (semaglutide) — full drug profile →
• Matching Placebo-Part A — full drug profile →
• Matching Placebo-Trevogrumab — full drug profile →
• Matching Placebo-Garetosmab — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

Adults 18 to 80, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested.

Part A of the study is focused on healthy participants. Part B and C 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 and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy.

Parts A, B, and C 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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic applications and challenges in myostatin inhibition for enhanced skeletal muscle mass and functions.
   Wetzlich B, Nyakundi BB, Yang J. · · 2025 · cited 37× · PMID 39340593 · DOI 10.1007/s11010-024-05120-y
2. New drugs for the treatment of obesity: do we need approaches to preserve muscle mass?
   Ryan DH. · · 2025 · cited 11× · PMID 40320499 · DOI 10.1007/s11154-025-09967-4
3. GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial.
   Gonzalez Trotter D, Donahue S, Wynne C, Ali S, et al · · 2025 · cited 9× · PMID 40360471 · DOI 10.1038/s41467-025-59380-3
4. Why are we still in need for novel anti-obesity medications?
   Novikoff A, Grandl G, Liu X, D Müller T. · · 2024 · cited 7× · PMID 39726721 · DOI 10.1016/j.lanepe.2024.101098
5. Paradigm shift in obesity treatment: an extensive review of current pipeline agents.
   Çetin E, Pedersen B, Burak MF. · · 2025 · cited 2× · PMID 40104296 · DOI 10.55730/1300-0144.5938
6. Muscle loss and GLP-1R agonists use.
   Rossi G, Bucciarelli L, Mananguite CL, Giovarelli M, et al · · 2026 · cited 1× · PMID 41201615 · DOI 10.1007/s00592-025-02611-2
7. Development of pharmacological interventions for the treatment of sarcopenia.
   Yang D, Su L, Zhang L, Li Y, et al · · 2026 · PMID 42164047 · DOI 10.21037/atm-2025-1-184
8. Obesity Pharmacotherapy: An Urgent Need for Progressing Science, Access, and Equity-JACC: Advances Expert Panel.
   Gouda P, Allyn N, Belin R, Borentain M, et al · · 2026 · PMID 41931082 · DOI 10.1016/j.jacadv.2026.102713