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MET097 · 5 trials · 5 indications
Evaluate the efficacy at Week 28 of four dose regimens of QW MET097 switching to QM compared to placebo.
Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance. The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.
| 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...
MET097 is an investigational small molecule being developed for obesity and overweight, including obesity in people with diabetes. It is studied in adults with obesity or overweight, and clinical trials are evaluating once-weekly and once-monthly dosing regimens for weight management.
MET097 is a small molecule being developed by Metsera, Inc. for metabolic conditions including obesity and overweight. The specific molecular target of MET097 is not disclosed in the available clinical trial information, so its mechanism of action has not been publicly detailed.
MET097 is being developed by Metsera, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MTSR. Metsera is conducting clinical trials of MET097 in the United States and multiple other countries for the treatment of obesity and overweight.
MET097 is in Phase 2 clinical development for obesity and overweight. The company has completed a Phase 2b study and is currently conducting another Phase 2b trial with once-monthly dosing. A Phase 3 study is also active but not recruiting participants.
MET097 has been studied in several clinical trials. NCT06712836 was a completed Phase 2b study in adults with obesity or overweight. NCT06857617 was a completed Phase 1 trial. NCT06973720 is an active Phase 2b study of once-monthly dosing, and NCT07311850 is an active Phase 3 trial.
MET097 is the sole name used for this investigational drug in the clinical trial records. No alternative names or brand names have been listed for MET097 in the available information from Metsera, Inc. or the clinical trials registry.