Phase
Condition
Obesity
Hypertriglyceridemia
Diabetes Prevention
Treatment
MET097
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) at Screening of:
BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbiditieslisted below)
BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the followingweight-related co-morbidities:
- Hypertension: on blood pressure (BP)-lowering medication or havingsystolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
- Dyslipidemia: on lipid-lowering medication or having low-densitylipoprotein 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 womenat Screening
- Stable body weight (increase or decrease ≤5 kg) within 3 months prior toScreening
Exclusion
Exclusion Criteria:
Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% orfasting 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 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
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 atScreening visit
A change in antihypertensive medications within 30 days of Screening visit
Renal artery stenosis, or evidence of labile blood pressure includingsymptomatic postural hypotension at Screening; postural hypotension is definedas a sustained reduction of systolic blood pressure of at least 20 mmHg ordiastolic blood pressure of 10 mmHg, with or without symptoms during theassessment, within three minutes of standing
Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0mIU/L at the Screening visit. Note: participants receiving treatment forhypothyroidism may be included, provided their thyroid hormone replacement dose hasbeen stable for at least 6 months
Study Design
Study Description
Connect with a study center
Research Site 097203-001001
Hollywood, Florida 33024
United StatesActive - Recruiting
Research Site 097203-001003
Tampa, Florida 33613
United StatesActive - Recruiting
Research Site 097203-001002
Decatur, Georgia 30030
United StatesActive - Recruiting
Research Site 097203-001005
Savannah, Georgia 31405
United StatesActive - Recruiting
Research Site 097203-001004
Marlton, New Jersey 08053
United StatesActive - Recruiting
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