Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MET097 · 5 trials · 5 indications
Evaluate the efficacy at Week 28 of four dose regimens of QW MET097 switching to QM compared to placebo.
| 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 |
| MET097 | EXPERIMENTAL | Participants will be randomized to one of four dosing regimens receiving twelve weekly doses of MET097 (with or without titration) followed by multiple monthly doses. |
| MET097 Active with titration | EXPERIMENTAL | - |
| MET097 Active without titration | EXPERIMENTAL | - |
| MET097 Active | EXPERIMENTAL | MET097 will be administered at four different dose levels subcutaneously once-weekly without titration. The extension phase includes dosing regimens that are less frequent than weekly. |
| (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 |
| MET097 Injection | DRUG | MET097 is an ultra-long-acting, fully-biased analog of human GLP-1. |
| (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...