Evaluating MET097 for weight loss in adults with obesity or overweight

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of Multiple Dose Regimens of Once-Weekly Switching to Once-Monthly MET097 in Participants With Obesity or Overweight (VESPER-3)

This study is testing a new weight loss medication called MET097 to see if it helps adults who are overweight or obese lose weight safely over a period of 15 months.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Metsera (industry)
• Locations: 5 sites (Hollywood, Florida and 4 other locations)
• Trial ID: NCT06973720 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of MET097, a medication for weight loss, in adults with obesity or overweight. Participants will receive either MET097 or a placebo for 12 weeks, followed by a transition to a higher monthly dose for an additional 13 months. The study is randomized, double-blind, and placebo-controlled, ensuring that neither the participants nor the researchers know who receives the active treatment. The primary endpoint will be evaluated at Week 28, four weeks after the last monthly dose.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a BMI of 27 or higher who do not have diabetes and may have weight-related co-morbidities.

Not a fit: Patients with diabetes or significant kidney impairment are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for adults struggling with obesity or overweight.

How similar studies have performed: Previous studies have shown promise with similar GLP-1 based treatments for weight loss, indicating potential for success in this approach.

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
    3. 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
* Poorly controlled hypertension at, defined as any of the following:

  * Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at Screening visit
  * A change in antihypertensive medications within 30 days of Screening visit
  * Renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension at Screening; postural hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg, with or without symptoms during the assessment, within three minutes of standing
* Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months

Where this trial is running

Hollywood, Florida and 4 other locations

• Research Site 097203-001001 — Hollywood, Florida, United States (RECRUITING)
• Research Site 097203-001003 — Tampa, Florida, United States (RECRUITING)
• Research Site 097203-001002 — Decatur, Georgia, United States (RECRUITING)
• Research Site 097203-001005 — Savannah, Georgia, United States (RECRUITING)
• Research Site 097203-001004 — Marlton, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Metsera Recruiting

Conditions: Obesity, Overweight or Obesity, Overweight, GLP-1