A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

Description

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

Conditions

Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM)

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Study Overview

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Study Details

Study overview

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)

A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

Condition
Obesity in Diabetes
Intervention / Treatment

-

Contacts and Locations

Hollywood

Research Site MET097 24-202-001, Hollywood, Florida, United States, 33024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
  • * Type 2 diabetes mellitus (\*T2DM) for at least 3 months before screening
  • * Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
  • * Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening
  • * Female who is lactating or who is pregnant
  • * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2
  • * Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
  • * Poorly controlled hypertension
  • * History of stroke
  • * Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
  • * Diagnosis of Type 1 diabetes
  • * History of acute or chronic 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
  • * Diagnosis of Type 1 diabetes
  • * Relevant surgical history including all bariatric or weight loss surgeries

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Metsera,

Study Record Dates

2026-06