ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-03-14
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06897202

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
  2. * Type 2 diabetes mellitus (\*T2DM) for at least 3 months before screening
  3. * 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)
  4. * Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening
  1. * Female who is lactating or who is pregnant
  2. * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2
  3. * Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
  4. * Poorly controlled hypertension
  5. * History of stroke
  6. * 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
  7. * Diagnosis of Type 1 diabetes (history of ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM)
  8. * History of acute or chronic pancreatitis
  9. * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  10. * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
  11. * Relevant surgical history including all bariatric or weight loss surgeries
  12. * SGLT2 inhibitors and/or metformin
  13. * Had 1 or more episodes of hypoglycemia

Contacts and Locations

Study Locations (Sites)

Research Site US-97202-001012
Chula Vista, California, 91911
United States
Research Site US-97202-001019
Los Alamitos, California, 90720
United States
Research Site US-97202-001021
Los Angeles, California, 90017
United States
Research Site US-97202-001007
Riverside, California, 92506
United States
Research Site US-97202-001024
Bradenton, Florida, 34209
United States
Research Site 097202-001001
Hollywood, Florida, 33024
United States
Research Site 097202-001003
Tampa, Florida, 33613
United States
Research Site 097202-001002
Decatur, Georgia, 30030
United States
Research Site US-97202-001009
Riverdale, Georgia, 30274
United States
Research Site 097202-001005
Savannah, Georgia, 31405
United States
Research Site US-97202-001017
Morton, Illinois, 61550
United States
Research Site US-97202-001022
Naperville, Illinois, 60540
United States
Research Site US-97202-001008
Kansas City, Kansas, 66112
United States
Research Site US-97202-001015
Columbia, Maryland, 21045
United States
Research Site US-97202-001006
Gaithersburg, Maryland, 20877
United States
Research Site US-97202-001004
Marlton, New Jersey, 08053
United States
Research Site US-97202-001016
Charlotte, North Carolina, 28277
United States
Research Site 097202-001010
Cincinnati, Ohio, 75234
United States
Research Site US-97202-001023
Plano, Texas, 75093
United States
Research Site US-97202-001013
Sherman, Texas, 75092
United States

Collaborators and Investigators

Sponsor: Metsera

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-14
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-14
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • GLP-1
  • Metsera
  • T2DM
  • Obesity
  • Overweight
  • Weight Loss

Additional Relevant MeSH Terms

  • Obesity in Diabetes
  • Type 2 Diabetes Mellitus (T2DM)