Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
NCT Number: NCT06500299
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Overweight and Obesity
Interventions: DRUG: HDM1002 100 mg QD|DRUG: HDM1002 200 mg QD 12weeks|DRUG: HDM1002 400 mg QD 12weeks|DRUG: Placebo
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-11-30

Summary:
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.

Primary Outcome Measures: Percentage Change From Baseline in Body Weight at Week 12, Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 12
Secondary Outcome Measures: 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., 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., 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, 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., Baseline, Week 12|Change From Baseline in Systolic and Diastolic Blood Pressure, Blood Pressure was measured using an automated device, 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, 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), Through Week 16]
Other Outcome Measures: Change From Baseline in Fasting Insulin, The fasting plasma glucose measures the levels of Fasting Insulin were measured at planned time points, Time Frame: Baseline, Week 12|Change From Baseline in Fasting plasma Glucose, The fasting plasma glucose measures the levels of glucose in the bloodFasting Insulin were measured at planned time points, Time Frame: Baseline, Week 12|Change From Baseline in Fasting C-Peptide,, The fasting plasma glucose measures the levels of C-Peptide were measured at planned time points, Time Frame: Baseline, Week 12|Change From Baseline in HbA1c at Week 12, HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control, Time Frame: Baseline, Week 12|Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible), Area under the curve from time 0 to 24 h(AUC0-24h), Day 1, Day 15, Day 29, Day 57 and Day 85|Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible), Maximum plasma concentration (Cmax),, Day 1, Day 15, Day 29, Day 57 and Day 85|Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible), Minumum plasma concentration (Cmin), Day 1, Day 15, Day 29, Day 57 and Day 85|Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible), Time to maximum plasma concentration (Tmax), Day 1, Day 15, Day 29, Day 57 and Day 85|Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible), AUCtau, Day 1, Day 15, Day 29, Day 57 and Day 85