A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of 28 Weeks to Investigate the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight Followed by a 32-Week Extension (VESPER-1)

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. Participants who have completed the first 28 weeks may participate in an exploratory extension study.

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. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.

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.