Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

Phase 2

Not yet recruiting

• Conditions: Overweight and Obesity
• Interventions: Drug: HDM1002 100 mg QD; Drug: HDM1002 200 mg QD 12weeks; Drug: HDM1002 400 mg QD 12weeks; Drug: Placebo

• Registration Number: NCT06500299
• Lead Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study Start: 2024-07-15
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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:

  1. Hypertension
  2. Impaired fasting glucose or impaired glucose tolerance
  3. Dyslipidemia
  4. 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 2.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HDM1002 100mg BID	HDM1002 100 mg QD	HDM1002 tablets 100mg twice daily, 12weeks
HDM1002 200mg BID	HDM1002 200 mg QD 12weeks	HDM1002 tablets 200mg twice daily, 12weeks
HDM1002 400mg QD	HDM1002 400 mg QD 12weeks	HDM1002 tablets 400mg once daily, 12weeks
placebo	Placebo	Matching placebo will be provided， 12weeks

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Body Weight at Week 12	Baseline, Week 12	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.

Secondary Outcome Measures

Name	Time	Method
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	Fasting Lipid Profiles were measured at planned time points.
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	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Change From Baseline in Systolic and Diastolic Blood Pressure	Baseline, Week 12	Blood Pressure was measured using an automated device
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12	Baseline, Week 12	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Change From Baseline in Body Mass Index (BMI), And Waist Circumference	Baseline, Week 12	BMI was recorded in kg/m2, and Waist Circumference was recorded in cm
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]	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)