Clinical trial NCT06712836: A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults with Obesity or Overweight
Official title: A Phase 2b, Multi-Center, Randomized, Placebo-Controlled Double-Blind Study to Investigate the Safety and Efficacy of Once-Weekly MET097 in Participants with Obesity and Overweight (VESPER-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight or Obesity
Keywords: Overweight
GLP-1
Lead sponsor: Metsera
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent change from baseline in body weight at Week 28
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
Secondary outcomes:
measure: Weight reduction (weight loss) from baseline that is ≥ 5%
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Weight reduction (weight loss) from baseline that is ≥ 10%
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Weight reduction (weight loss) from baseline that is ≥ 15%
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change from baseline in body weight (kg)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change from baseline in body mass index (BMI)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change from baseline in waist circumference
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Occurrence of treatment emergent adverse events (TEAEs)
timeFrame: Baseline (Week 0) through Week 37 (Day 265)
measure: Minimum observed concentration (Cmin)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Area under the concentration versus time curve during the dosing interval (AUC(0-τ))
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Maximum observed concentration (Cmax)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Time to maximum concentration (Tmax)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site MET097 24-201-001
state: California
city: Hollywood
country: United States
facility: Research Site MET097 24-201-002
state: Florida
Study officials:
References: