Evaluating a new treatment for obesity and type 2 diabetes

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)

This study is testing a new weekly injection for people with obesity and type 2 diabetes to see if it helps them lose weight and manage their condition better than a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Metsera (industry)
• Locations: 5 sites (Hollywood, Florida and 4 other locations)
• Trial ID: NCT06897202 on ClinicalTrials.gov

What this trial studies

This study tests the efficacy and safety of MET097, an ultra-long-acting GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes mellitus (T2DM). Participants will receive either MET097 or a placebo via subcutaneous injection once a week for 28 weeks. The study is randomized, double-blind, and placebo-controlled, comparing four different dosing regimens of MET097 against placebo. After the treatment period, participants will be monitored for an additional four weeks to assess the long-term effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a BMI between 27 and 50 kg/m2 and a diagnosis of T2DM for at least three months.

Not a fit: Patients with significant cardiovascular disease, poorly controlled hypertension, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly aid in weight loss and improve glycemic control for patients with obesity and T2DM.

How similar studies have performed: Other studies have shown promise with GLP-1 receptor agonists in treating obesity and T2DM, indicating a potential for success with this approach.

Eligibility 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

Where this trial is running

Hollywood, Florida and 4 other locations

• Research Site 097202-001001 — Hollywood, Florida, United States (RECRUITING)
• Research Site 097202-001003 — Tampa, Florida, United States (RECRUITING)
• Research Site 097202-001002 — Decatur, Georgia, United States (RECRUITING)
• Research Site 097202-001005 — Savannah, Georgia, United States (RECRUITING)
• Research Site 097202-001010 — Cincinnati, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Metsera Recruiting

Conditions: Obesity in Diabetes, Type 2 Diabetes Mellitus, GLP-1, Metsera, T2DM, Obesity, Overweight, Weight Loss