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Also known as (Part C) MET097, MET097 Injection, PF-08653944
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...
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MET097 is an investigational small molecule being developed by Metsera, Inc. (ticker MTSR) for the treatment of obesity, overweight, and obesity in people with type 2 diabetes. It is a metabolic therapy in clinical development and is also referred to as MET097 Injection.
MET097 is being studied for obesity, overweight, and obesity in diabetes. Clinical trials have enrolled adults with overweight or obesity, including a Phase 2 study in adults with obesity or overweight and type 2 diabetes. It is investigational and has not been approved for any use.
MET097 is developed by Metsera, Inc., which trades under the ticker MTSR. Metsera is the sponsor of the clinical program evaluating MET097 in obesity and overweight, including a Phase 3 trial and Phase 2 trials.
MET097 is in Phase 2 development, with a Phase 3 trial also underway. The Phase 3 study NCT07311850 is active but not recruiting, and Phase 2 studies include NCT06973720 and the completed NCT06897202. MET097 is investigational and has not been approved.
MET097 has been studied in four registered trials. NCT07311850 is a Phase 3 trial in overweight or obesity, NCT06973720 is a Phase 2b once-monthly study, NCT06897202 is a completed Phase 2 trial in obesity with type 2 diabetes, and NCT06857617 is a completed Phase 1 study.
Yes. MET097 Injection is another name for MET097, and the drug is also listed as (Part C) MET097. All of these names refer to the same investigational small molecule developed by Metsera, Inc. for obesity and overweight.