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
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 180
- Primary Endpoint
- Percentage Change From Baseline in Body Weight at Week 12
Study Overview
Brief 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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female subjects between 18 and 65 years of age (inclusive).
- •BMI≥28 but < 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but < 28 kg/m2 with any of the following:
- •Hypertension
- •Impaired fasting glucose or impaired glucose tolerance
- •Dyslipidemia
- •Obstructive sleep apnea syndrome
- •At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification.
Exclusion Criteria
- •Weight change ≥5% as reported or documented. Previous diagnosis of type 1, type 2, or any other type of diabetes.
- •Diagnosis of overweight or obesity due to other diseases or medications.
- •History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type
- •Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
- •GLP-1R agonist use within 6 months prior to signing ICF.
- •Use of hypoglycemic drugs within 3 months before signing ICF.
Arms & Interventions
placebo
Matching placebo will be provided， 12weeks
Intervention: Placebo (Drug)
HDM1002 100mg BID
HDM1002 tablets 100mg twice daily, 12weeks
Intervention: HDM1002 100 mg QD (Drug)
HDM1002 200mg BID
HDM1002 tablets 200mg twice daily, 12weeks
Intervention: HDM1002 200 mg QD 12weeks (Drug)
HDM1002 400mg QD
HDM1002 tablets 400mg once daily, 12weeks
Intervention: HDM1002 400 mg QD 12weeks (Drug)
Outcomes
Primary Outcomes
Percentage Change From Baseline in Body Weight at Week 12
Time Frame: Baseline, Week 12
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Secondary Outcomes
- 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)(Baseline, Week 12)
- Percentage Change From Baseline in Body Weight at Week 2, Week 4, Week 6, Week 8, Week 10(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10)
- Change From Baseline in Systolic and Diastolic Blood Pressure(Baseline, Week 12)
- Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12(Baseline, Week 12)
- Change From Baseline in Body Mass Index (BMI), And Waist Circumference(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(Through Week 16])