It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults.
This multicenter, randomized, double-blind, placebo-controlled phase II clinical trial aims to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults. Participants with a BMI between 24 and 40 will be include. A total of 180 participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or placebo. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a treatment period will be 12 weeks, followed by an approximate 4-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
HDM1002 tablets 100mg daily, 12weeks
HDM1002 tablets 200mg daily, 12weeks
HDM1002 tablets 400mg daily, 12weeks
Percentage Change From Baseline in Body Weight at Week 12
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 12
Percentage Change From Baseline in Body Weight at Week 2, Week 4, Week 6, Week 8, Week 10
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 12
Change From Baseline in Body Mass Index (BMI), And Waist Circumference
BMI was recorded in kg/m2, and Waist Circumference was recorded in cm
Time frame: Baseline, Week 12
Percentage change from baseline in fasting lipid profile (total cholesterol, low density lipoprotein [LDL] cholesterol, high density lipoprotein [HDL] cholesterol, non HDL cholesterol, lipoprotein (a) (Lp[a]), triglycerides)
Fasting Lipid Profiles were measured at planned time points.
Time frame: Baseline, Week 12
Change From Baseline in Systolic and Diastolic Blood Pressure
Blood Pressure was measured using an automated device
Time frame: Baseline, Week 12
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram and Number of Participants With Treatment Emergent Adverse Events
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Matching placebo will be provided
Vital signs (blood pressure, pulse rate, body temperature, respiratory rate), physical examination, ECG and clinical laboratory evaluations (hematology, clinical chemistry, coagulation, urinalysis, calcitonin, serum amylase and lipase)
Time frame: Through Week 16]