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NCT06897202 | RECRUITING | Obesity in Diabetes

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

Mesera

Brief Summary:

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.

Condition or disease

Obesity in Diabetes

Type 2 Diabetes Mellitus (T2DM)

Intervention/treatment

MET097 Injection

Placebo

Phase

PHASE2

Detailed Description:

This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index \[BMI\] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.

Study Type : INTERVENTIONAL
Estimated Enrollment : 125 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-03-14
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
Exclusion Criteria
  • * 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
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

Location Details

NCT06897202

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How to Participate

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Locations

RECRUITING

United States, Florida

Research Site 097202-001001

Hollywood, florida, United States, 33024

RECRUITING

United States, Florida

Research Site 097202-001003

Tampa, florida, United States, 33613

RECRUITING

United States, Georgia

Research Site 097202-001002

Decatur, Georgia, United States, 30030

RECRUITING

United States, Georgia

Research Site 097202-001005

Savannah, Georgia, United States, 31405

RECRUITING

United States, Ohio

Research Site 097202-001010

Cincinnati, Ohio, United States, 75234