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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07311850 | Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity | PHASE3 | RECRUITING | 3,501 | — | — | Dec 19, 2025 | Apr 25, 2028 | May 29, 2026 | 195 | United States, Argentina +9 |
| NCT06857617 | This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity | PHASE1 | COMPLETED | 120 | — | — | Apr 1, 2024 | Mar 15, 2025 | Jan 28, 2026 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| MET097 Dose 1 | EXPERIMENTAL | Participants will receive MET097 administered subcutaneously |
| MET097 Dose 2 | EXPERIMENTAL | Participants will receive MET097 administered subcutaneously |
| MET097 Dose 3 | EXPERIMENTAL | Participants will receive MET097 administered subcutaneously |
| Placebo | PLACEBO_COMPARATOR | Once-weekly placebo administered via subcutaneous injection |
| (Part C) MET097 | EXPERIMENTAL | Once-weekly subcutaneous injection of MET097 for 13 weeks |
| (Part C) Placebo | PLACEBO_COMPARATOR | Once-weekly subcutaneous injection of Placebo for 13 weeks |
| Name | Type | Description |
|---|---|---|
| MET097 | DRUG | Once-weekly MET097 administered via subcutaneous injection |
| Placebo | DRUG | Once-weekly placebo administered via subcutaneous injection |
| (Part C) MET097 | BIOLOGICAL | Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows: * 12 once-weekly doses of 0.6mg followed by a 13th dose of 1.2mg * 12 once-weekly doses of 0.6mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 1.6 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 3.2 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 2.0 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 4.0 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 4.8 mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 2.4mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 4.8mg |
| (Part C) Placebo | BIOLOGICAL | Participants will receive 13 once-weekly subcutaneous injections of matching placebo |
Inclusion Criteria: * BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to \<30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) Exclusion Criteria: * Have any form of diabetes * Have a self-reporte...