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

Phase 3

Not yet recruiting

• Conditions: Overweight and Obesity
• Interventions: Drug: HDM1002 200mg, oral, once daily, 52 weeks; Drug: HDM1002 400mg, oral, once daily, 52 weeks; Drug: HDM1002 placebo, oral, once daily, 52 weeks

• Registration Number: NCT06885021
• Lead Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Brief Summary

A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-03-28
• Primary Completion: 2026-05-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• 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. Dyslipidemia
  3. Obstructive sleep apnea syndrome
  4. MASH
  5. Pain in the weight-bearing joints

• 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 tablets 200mg once daily	HDM1002 200mg, oral, once daily, 52 weeks	HDM1002 200mg, oral, once daily, 52weeks
HDM1002 tablets 400mg once daily	HDM1002 400mg, oral, once daily, 52 weeks	HDM1002 400mg, oral, once daily, 52weeks
Placebo	HDM1002 placebo, oral, once daily, 52 weeks	HDM1002 placebo, oral, once daily, 52weeks

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Body Weight	44weeks	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg,
Percentage Change of Participants Achieving Weight Loss ≥ 5%	44weeks	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg

Secondary Outcome Measures

Name	Time	Method
Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15%	44weeks	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Change From Baseline in Waist Circumference	44 weeks, 52 weeks	Waist Circumference was recorded in cm
Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15%	52 weeks	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.