Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trevogrumab · 1 trial · 1 indication
Part A
Part A
Part B
Part B
Part B
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Part A Randomized 1:1 |
| Trevogrumab | EXPERIMENTAL | Part A Randomized 1:1 |
| Arm A0 | EXPERIMENTAL | 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 |
| Arm A1 | EXPERIMENTAL | Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1 |
| Arm B0 | EXPERIMENTAL | Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 |
| Arm B1 | EXPERIMENTAL | Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 |
| Arm C0 | EXPERIMENTAL | Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 |
| Arm C1 | EXPERIMENTAL | Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 |
| Arm D0 | EXPERIMENTAL | Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1 |
| Arm D1 | EXPERIMENTAL | Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 |
| Arm 1 | EXPERIMENTAL | Part C Sema and SC placebo Randomized 1:2:2 |
| Arm 2 | EXPERIMENTAL | Part C Sema and SC low dose trevo Randomized 1:2:2 |
| Arm 3 | EXPERIMENTAL | Part C Sema and SC moderate dose trevo Randomized 1:2:2 |
| Name | Type | Description |
|---|---|---|
| Trevogrumab-Part A | DRUG | Administered IV or SC in Part A |
| Trevogrumab-Part B and Part C | DRUG | Administered SC in Part B, Part C |
| Garetosmab | DRUG | Administered IV in Part B |
| Semaglutide | DRUG | Administered SC in Part B and Part C |
| Matching Placebo-Part A | DRUG | Administered IV or SC in Part A |
| Matching Placebo-Trevogrumab | DRUG | Administered SC in Part B and Part C |
| Matching Placebo-Garetosmab | DRUG | Administered IV in Part B |
Key Inclusion Criteria Part A 1. Male or female participants age ≥18 to ≤55 years of age at the time of screening 2. BMI ≥18 and ≤32 kg/m2, at the screening visit Part B and Part C 3. Male or female participants ≥18 to ≤80 years of age at the time of screening 4. BMI ≥30 kg/m2, at the screenin...
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Trevogrumab is an investigational monoclonal antibody being studied for obesity. It is being evaluated in adults with obesity for weight loss, fat loss, and preservation of lean body mass. It is not approved for any indication and remains in clinical development.
Trevogrumab targets MSTN, also known as myostatin. It is an inhibitor of this target. By binding MSTN, the antibody is designed to affect muscle-related biology, which is the rationale for studying it alongside weight-loss therapy to help preserve lean mass during obesity treatment.
Trevogrumab is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating the antibody in obesity.
Trevogrumab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for obesity or any other indication.
Trevogrumab is being studied in the Phase 2 trial NCT06299098, titled 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. The trial is active but not recruiting, with 1,005 participants enrolled in the United States and Puerto Rico.