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

Phase 2

Active, not recruiting

• Conditions: Obesity; Overweight or Obesity
• Interventions: Drug: MET097; Drug: Placebo

• Registration Number: NCT06712836
• Lead Sponsor: Metsera

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-10-24
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MET097 Active	MET097	MET097 will be administered at four different dose levels subcutaneously once-weekly without titration.
Placebo	Placebo	Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in body weight at Week 28	Baseline (Week 0) through Week 28 (Day 197)	Evaluate the efficacy of once-weekly MET097 on body weight after 28 once-weekly doses compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Weight reduction (weight loss) from baseline that is ≥ 5%	Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 10%	Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 15%	Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in body weight (kg)	Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in body mass index (BMI)	Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in waist circumference	Baseline (Week 0) through Week 28 (Day 197)
Occurrence of treatment emergent adverse events (TEAEs)	Baseline (Week 0) through Week 37 (Day 265)	Treatment emergent adverse events include adverse events of clinical interest as well as abnormal clinical significant physical exams, laboratory findings, and 12-lead ECG measurements that meet the definition for an AE.
Minimum observed concentration (Cmin)	Baseline (Week 0) through Week 28 (Day 197)
Area under the concentration versus time curve during the dosing interval (AUC(0-τ))	Baseline (Week 0) through Week 31 (Day 220)
Maximum observed concentration (Cmax)	Baseline (Week 0) through Week 31 (Day 220)
Time to maximum concentration (Tmax)	Baseline (Week 0) through Week 31 (Day 220)

Trial Locations

Locations (2)

Research Site MET097 24-201-002; 🇺🇸 Hollywood, Florida, United States

Research Site MET097 24-201-001; 🇺🇸 Anaheim, California, United States