Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
Lead Sponsor:
Metsera
Conditions:
Obesity in Diabetes
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared t...
Detailed Description
This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing re...
Eligibility Criteria
Inclusion
- BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
- Type 2 diabetes mellitus (\*T2DM) for at least 3 months before screening
- Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
- Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening
Exclusion
- Female who is lactating or who is pregnant
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2
- Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
- Poorly controlled hypertension
- History of stroke
- Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
- Diagnosis of Type 1 diabetes (history of ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM)
- History of acute or chronic 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
- Relevant surgical history including all bariatric or weight loss surgeries
- SGLT2 inhibitors and/or metformin
- Had 1 or more episodes of hypoglycemia
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT06897202
Start Date
March 14 2025
End Date
March 1 2026
Last Update
December 17 2025
Active Locations (20)
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1
Research Site US-97202-001012
Chula Vista, California, United States, 91911
2
Research Site US-97202-001019
Los Alamitos, California, United States, 90720
3
Research Site US-97202-001021
Los Angeles, California, United States, 90017
4
Research Site US-97202-001007
Riverside, California, United States, 92506