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

NCT06973720 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: VESPER-3 (MET097-25-203)C6491006
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 5

Brief Summary

This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.

Conditions

Overweight or Obesity; Obesity

Keywords

Overweight; GLP-1

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in body weight at Week 28

  Evaluate the efficacy at Week 28 of four dose regimens of QW MET097 switching to QM compared to placebo.

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

Secondary Outcomes (14)

• Percent change from baseline in body weight at Week 64

  Baseline (Week 0) through Week 64 (Day 449)

• Percent change from baseline in body weight at all other post-baseline weight measurements up to Week 64 other than Week 28

  Baseline (Week 0) through Week 24 (Day 169); Week 32 (Day 225) through Week 64 (Day 449)

• Change from baseline in absolute bodyweight (in kg) at all protocol-specified weekly and monthly post-baseline measurements

  Baseline (Week 0) through Week 64 (Day 449)

• Change from baseline in body mass index (BMI) at all protocol-specified weekly and monthly post-baseline measurements

  Baseline (Week 0) through Week 64 (Day 449)

• Change from baseline in waist circumference (in cm) at all protocol-specified weekly and monthly post-baseline measurements

  Baseline (Week 0) through Week 64 (Day 449)

Study Arms (2)

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.

Drug: MET097

Placebo

PLACEBO COMPARATOR

Participants who are randomized to the placebo arm will receive twelve weekly doses of placebo followed by multiple monthly doses.

Drug: Placebo

Interventions

MET097 DRUG

For subcutaneous administration.

MET097

Placebo DRUG

Sterile 0.9% (w/v) saline for subcutaneous administration.

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
• Poorly controlled hypertension at, defined as any of the following:
• Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at Screening visit
• A change in antihypertensive medications within 30 days of Screening visit
• Renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension at Screening; postural hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg, with or without symptoms during the assessment, within three minutes of standing
• Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months

Sponsors & Collaborators

• Metsera, a wholly owned subsidiary of Pfizer: lead

Study Sites (5)

Research Centers of America

Hollywood, Florida, 33024, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

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: May 6, 2025
• First Posted: May 15, 2025
• Study Start: April 7, 2025
• Primary Completion: December 16, 2025
• Study Completion (Estimated): October 16, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (5)