A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults with Obesity or Overweight (VESPER-1)

Metsera

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight or Obesity; Obesity

Treatments: Drug: Placebo; Drug: MET097

Study type: Interventional

Funder types: Industry

Identifiers

NCT06712836

MET097-24-201

Details and patient eligibility

About

This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels.

Full description

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index [BMI] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. All participants will be followed for 11 weeks (~5 half-lives) after administration of the last weekly dose for safety.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) at Screening of:

  • BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below)

  • BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the following weight-related co-morbidities:

    1. Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
    2. Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for women at Screening

Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening

Exclusion criteria

• Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose >125 mg/dL.
• Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2
• History of 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
• Any lifetime history of a suicide attempt.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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225 participants in 2 patient groups, including a placebo group

MET097 Active

Experimental group

Description:

MET097 will be administered at four different dose levels subcutaneously once-weekly without titration.

Treatment:

Drug: MET097

Placebo

Placebo Comparator group

Description:

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Treatment:

Drug: Placebo