A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight

NCT ID: NCT06712836

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2026-05-31

Brief Summary

This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index [BMI] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.

Conditions

Obesity; Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MET097 Active

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.

Group Type: EXPERIMENTAL

MET097

Intervention Type: DRUG

MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.

Placebo

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Interventions

MET097

MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.

Intervention Type: DRUG

Placebo

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) at Screening of:

• BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below)
• BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the following weight-related co-morbidities:

1. Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening

2. Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for women at Screening

Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening

Exclusion Criteria

• Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose >125 mg/dL.
• Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2
• History of pancreatitis
• Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
• Any lifetime history of a suicide attempt.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Metsera

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Research Site MET097 24-201-001

Anaheim, California, United States

Research Site MET097 24-201-002

Hollywood, Florida, United States

Countries

United States

Other Identifiers

MET097-24-201

Identifier Type: -

Identifier Source: org_study_id