About this trial
It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HDM1005 injection in nondiabetic obese adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Previous diagnosis of type 1, type 2, or any other type of diabetes.
History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
According to the investigator's judgment, the subjects have endocrine diseases or histories that affect gastric emptying, may significantly affect body weight, or diseases or conditions that affect the absorption of gastrointestinal nutrients, such as Cushing syndrome, hypothyroidism or hyperthyroidism, bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, and chronic pancreatitis; Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
Unstable angina pectoris;
Trial design
Parallel
Treatments tested in this trial
HDM1005 injection or placebo
DrugHDM1005 injection subcutaneous injection QW for 22weeks
Treatment groups
Trial outcomes
Primary outcomes
Percentage Change From Baseline in Body Weight at Week 22
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Secondary outcomes
Percentage Change From Baseline in Body Weight at Week 4, Week 8, Week 12, Week 16
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 22
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Change From Baseline in Body Mass Index (BMI)
BMI was recorded in kg/m2
Change From Baseline in Waist Circumference
Waist Circumference was recorded in cm
Sponsors and contacts
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