Phase
Condition
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Diabetes And Hypertension
Treatment
Placebo
MET097 Injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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% (91.3mmol/mol) at Screening and treated with stable therapy for at least 30 days prior toScreening/Visit 1 (diet and exercise alone or in combination with metforminmonotherapy and/or SGLT-2)
Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening
Exclusion
Exclusion Criteria:
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 orvalvular heart disease or has a history of myocardial infarction, coronary arterybypass graft, percutaneous coronary artery re-vascularization, or congestive heartfailure
Diagnosis of Type 1 diabetes
History of acute or chronic pancreatitis
Family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2)
History of significant active or unstable major depressive disorder (MDD) or othersevere psychiatric disorder within the last 2 years
Diagnosis of Type 1 diabetes
Relevant surgical history including all bariatric or weight loss surgeries
Study Design
Study Description
Connect with a study center
Research Site 097202-001001
Hollywood, Florida 33024
United StatesActive - Recruiting
Research Site MET097 24-202-001
Hollywood, Florida 33024
United StatesActive - Recruiting
Research Site 097202-001003
Tampa, Florida 33613
United StatesActive - Recruiting
Research Site 097202-001002
Decatur, Georgia 30030
United StatesActive - Recruiting
Research Site 097202-001005
Savannah, Georgia 31405
United StatesActive - Recruiting
Research Site 097202-001010
Cincinnati, Ohio 75234
United StatesActive - Recruiting
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