Status:
ACTIVE_NOT_RECRUITING
A Phase 2b Study to Evaluate the Efficacy and Safety of Once-Monthly MET097 in Adults With Obesity or Overweight
Lead Sponsor:
Metsera
Conditions:
Obesity
Overweight or Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have ...
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of multiple once monthly (QM) dose levels of MET097 after 12 once weekly...
Eligibility Criteria
Inclusion
- 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:
- Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06973720
Start Date
April 1 2025
End Date
October 1 2026
Last Update
June 4 2025
Active Locations (5)
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1
Research Site 097203-001001
Hollywood, Florida, United States, 33024
2
Research Site 097203-001003
Tampa, Florida, United States, 33613
3
Research Site 097203-001002
Decatur, Georgia, United States, 30030
4
Research Site 097203-001005
Savannah, Georgia, United States, 31405