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

NCT06885021 | Not Yet Recruiting Phase 3

• 1 other identifier: HDM1002-301
• Study Type: interventional
• Target: 780
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage Change From Baseline in Body Weight

  Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg,

  44weeks

• Percentage Change of Participants Achieving Weight Loss ≥ 5%

  Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg

  44weeks

Secondary Outcomes (3)

• Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15%

  44weeks

• Change From Baseline in Waist Circumference

  44 weeks, 52 weeks

• Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15%

  52 weeks

Study Arms (3)

HDM1002 tablets 200mg once daily

EXPERIMENTAL

HDM1002 200mg, oral, once daily, 52weeks

Drug: HDM1002 200mg, oral, once daily, 52 weeks

HDM1002 tablets 400mg once daily

EXPERIMENTAL

HDM1002 400mg, oral, once daily, 52weeks

Drug: HDM1002 400mg, oral, once daily, 52 weeks

Placebo

PLACEBO COMPARATOR

HDM1002 placebo, oral, once daily, 52weeks

Drug: HDM1002 placebo, oral, once daily, 52 weeks

Interventions

HDM1002 200mg, oral, once daily, 52 weeks DRUG

HDM1002 200mg, oral, once daily, 52 weeks

HDM1002 tablets 200mg once daily

HDM1002 400mg, oral, once daily, 52 weeks DRUG

HDM1002 400mg, oral, once daily, 52 weeks

HDM1002 tablets 400mg once daily

HDM1002 placebo, oral, once daily, 52 weeks DRUG

HDM1002 placebo, oral, once daily, 52 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Dyslipidemia
• Obstructive sleep apnea syndrome
• MASH
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Liu Jing Liu

CONTACT

+8657189903388; cxyliujing@eastchinapharm.com

Wenwen Tu

CONTACT

+86-0571-89903388; tuwenwen@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03