A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM (VESPER-2)

Metsera

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes Mellitus (T2DM); Obesity in Diabetes

Treatments: Drug: MET097 Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06897202

MET097-24-202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 3 patient groups, including a placebo group

MET097 Active with titration

Experimental group

Treatment:

Drug: MET097 Injection

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

MET097 Active without titration

Experimental group

Treatment:

Drug: MET097 Injection