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

NCT06712836 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: VESPER-1 (MET097-24-201)
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Overweight or Obesity

Keywords

Overweight; GLP-1

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in body weight at Week 28

  Evaluate the efficacy of once-weekly MET097 on body weight after 28 once-weekly doses compared to placebo.

  Baseline (Week 0) through Week 28 (Day 197)

Secondary Outcomes (13)

• Weight reduction (weight loss) from baseline that is ≥ 5%

  Baseline (Week 0) through Week 28 (Day 197)

• Weight reduction (weight loss) from baseline that is ≥ 10%

  Baseline (Week 0) through Week 28 (Day 197)

• Weight reduction (weight loss) from baseline that is ≥ 15%

  Baseline (Week 0) through Week 28 (Day 197)

• Change from baseline in body weight (kg)

  Baseline (Week 0) through Week 28 (Day 197)

• Change from baseline in body mass index (BMI)

  Baseline (Week 0) through Week 28 (Day 197)

Study Arms (2)

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.

Drug: MET097

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MET097 DRUG

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

MET097 Active

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metsera, a wholly owned subsidiary of Pfizer: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Research Centers of America

Hollywood, Florida, 92801, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: October 24, 2024
• Primary Completion: July 3, 2025
• Study Completion: May 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (2)