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NCT Number: NCT06885021

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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.

Treatment and study plan

HDM1002 200mg, oral, once daily, 52 weeks

Drug

HDM1002 200mg, oral, once daily, 52 weeks

HDM1002 400mg, oral, once daily, 52 weeks

Drug

HDM1002 400mg, oral, once daily, 52 weeks

HDM1002 placebo, oral, once daily, 52 weeks

Drug

HDM1002 placebo, oral, once daily, 52 weeks

Primary outcomes

  1. Percentage Change From Baseline in Body Weight

    Time frame: 44weeks

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

  2. 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

Secondary outcomes

  1. 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.

  2. Change From Baseline in Waist Circumference

    Time frame: 44 weeks, 52 weeks

    Waist Circumference was recorded in cm

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Liu Jing Liu

CONTACT

[email protected]

+8657189903388

Wenwen Tu

CONTACT

[email protected]

+86-0571-89903388

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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