Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06299098 | 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 | PHASE2 | ACTIVE NOT_RECRUITING | 1,005 | — | — | Mar 13, 2024 | Oct 30, 2026 | May 8, 2026 | 60 | United States, Puerto Rico |
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...