Phase
Condition
Obesity
Hypertriglyceridemia
Diabetes Prevention
Treatment
MET233 and MET097
MET233
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening
For participants in Part A and B, no history of clinically significant diseases orclinically significant findings from the physical examination. For participants inPart C, no clinically significant diseases except T2DM, well controlledhypertension, and/or dyslipidemia.
For participants in Part C, diagnosed with T2DM for at least 3 months beforescreening.
For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5%at Screening and treated with stable therapy for at least 30 days prior toScreening/Visit 1.
Exclusion
Exclusion Criteria:
Female who is lactating or who is pregnant according to the pregnancy test atScreening or on Day 1.
Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior tothe first study drug administration.
Elevated resting pulse greater than 100 beats per minute at Screening visit or priorto the first study drug administration.
Estimated glomerular filtration rate (eGFR) <80 mL/min at the Screening visit.
Diagnosis of Type 1 diabetes.
For Part A and Part B: Diagnosis of T2DM or glycated hemoglobin (HbA1c) > 6.4% orfasting plasma glucose >126 mg/dL at the Screening visit or history of taking anymedications to lower glucose.
For Part A and Part B: Participant reported weight-related comorbidity, includingsleep apnea and cardiovascular disease.
History of bariatric or weight loss surgeries.
Personal or family history of medullary thyroid carcinoma or multiple endocrineneoplasia syndrome.
Lifetime history of acute or chronic pancreatitis or pancreatic cancer.
Participation in a weight loss program with or without pharmacotherapy during the 3months prior to study administration or plans to do so.
Study Design
Study Description
Connect with a study center
Research Site MET233/097 24-101-001
Cypress, California 90630
United StatesActive - Recruiting
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