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

March 13, 2025 updated by: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

780

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDM1002 tablets 200mg once daily
HDM1002 200mg, oral, once daily, 52weeks
Drug: HDM1002 200mg, oral, once daily, 52 weeks
HDM1002 200mg, oral, once daily, 52 weeks
Experimental: HDM1002 tablets 400mg once daily
HDM1002 400mg, oral, once daily, 52weeks
Drug: HDM1002 400mg, oral, once daily, 52 weeks
HDM1002 400mg, oral, once daily, 52 weeks
Placebo Comparator: Placebo
HDM1002 placebo, oral, once daily, 52weeks
Drug: HDM1002 placebo, oral, once daily, 52 weeks
HDM1002 placebo, oral, once daily, 52 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 28, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDM1002-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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