A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
NCT ID: NCT06897202
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
133 participants
INTERVENTIONAL
2025-03-14
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MET097 Active with titration
MET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
Placebo
Placebo
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
MET097 Active without titration
MET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
Interventions
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MET097 Injection
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
Placebo
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Metsera
INDUSTRY
Responsible Party
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Locations
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Research Site US-97202-001012
Chula Vista, California, United States
Research Site US-97202-001019
Los Alamitos, California, United States
Research Site US-97202-001021
Los Angeles, California, United States
Research Site US-97202-001007
Riverside, California, United States
Research Site US-97202-001024
Bradenton, Florida, United States
Research Site 097202-001001
Hollywood, Florida, United States
Research Site 097202-001003
Tampa, Florida, United States
Research Site 097202-001002
Decatur, Georgia, United States
Research Site US-97202-001009
Riverdale, Georgia, United States
Research Site 097202-001005
Savannah, Georgia, United States
Research Site US-97202-001017
Morton, Illinois, United States
Research Site US-97202-001022
Naperville, Illinois, United States
Research Site US-97202-001008
Kansas City, Kansas, United States
Research Site US-97202-001015
Columbia, Maryland, United States
Research Site US-97202-001006
Gaithersburg, Maryland, United States
Research Site US-97202-001004
Marlton, New Jersey, United States
Research Site US-97202-001016
Charlotte, North Carolina, United States
Research Site 097202-001010
Cincinnati, Ohio, United States
Research Site US-97202-001023
Plano, Texas, United States
Research Site US-97202-001013
Sherman, Texas, United States
Countries
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Other Identifiers
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MET097-24-202
Identifier Type: -
Identifier Source: org_study_id