A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight (VESPER-1)

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of 28 Weeks to Investigate the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight Followed by a 32-Week Extension (VESPER-1)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight or Obesity
• Intervention / Treatment: Drug: MET097; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
  • Florida
    • Hollywood, Florida, United States, 92801
      • Research Centers of America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.	Drug: Placebo; Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
Experimental: 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.	Drug: MET097; MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change from baseline in waist circumference		Baseline (Week 0) through Week 28 (Day 197)
Minimum observed concentration (Cmin)		Baseline (Week 0) through Week 28 (Day 197)
Area under the concentration versus time curve during the dosing interval (AUC(0-τ))		Baseline (Week 0) through Week 31 (Day 220)
Maximum observed concentration (Cmax)		Baseline (Week 0) through Week 31 (Day 220)
Time to maximum concentration (Tmax)		Baseline (Week 0) through Week 31 (Day 220)
Occurrence of treatment emergent adverse events (TEAEs)	Treatment emergent adverse events include adverse events of clinical interest as well as abnormal clinical significant physical exams, laboratory findings, and 12-lead ECG measurements that meet the definition for an AE.	Baseline (Week 0) through Week 37 (Day 265)
Percent change from baseline in body weight at all protocol-specified post-baseline measurements during the exploratory extension study		Week 28 to Week 60
Occurrence of treatment emergent adverse events (TEAEs) during the exploratory extension study	Week 28 to Week 60	Week 28 to Week 60

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): July 3, 2025
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Overweight
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: VESPER-1 (MET097-24-201); C6491004 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No