RecruitingPhase 3NCT07279194

Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes

Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

825 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity, Overweight

Summary

This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new weight-loss drug called HDM1005 in Chinese adults who are overweight or obese but do not have diabetes, to see if it is safe and helps reduce body weight. **You may be eligible if...** - You are 18 or older - Your BMI is 28 or higher; or your BMI is 24 or higher and you have at least one weight-related health condition (like high blood pressure, pre-diabetes, fatty liver, or sleep apnea) - Your weight has been stable (less than 5% change) for the past 3 months **You may NOT be eligible if...** - You have Type 1 or Type 2 diabetes - Your blood sugar or HbA1c are at diabetic levels - You have a hormonal cause for obesity (like Cushing's syndrome) - You have used GLP-1 receptor agonists or blood sugar medications in the past 3 months - You have a history of thyroid cancer, pancreatitis, or gallbladder disease - You have moderate-to-severe depression or a history of severe mental illness - You have serious heart or vascular disease in the past 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHDM1005 1

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.

DRUGHDM1005 2

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.

DRUGPlacebo