HDM1005 for non-diabetic Chinese adults with overweight or obesity

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

This trial will test whether once-weekly HDM1005 helps Chinese adults who are overweight or have obesity but do not have diabetes lose weight and remain safe over one year.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 825 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07279194 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, parallel-controlled Phase 3 trial in China assigns participants 1:1:1 to two different doses of once-weekly HDM1005 or placebo for 52 weeks, followed by a 4-week safety follow-up. All participants receive lifestyle counseling on diet and physical activity, and eligible adults must have BMI ≥28 kg/m2 or BMI ≥24 kg/m2 with at least one weight-related comorbidity and no diabetes. Key exclusions include diagnosed diabetes, HbA1c ≥6.5% or fasting glucose ≥7.0 mmol/L, obesity from other endocrine disorders, or recent use of GLP‑1/GIP-related drugs. The trial measures efficacy (weight change) and safety (adverse events and lab assessments) during the treatment period.

Who should consider this trial

Good fit: Adults in China aged 18 or older with BMI ≥28 kg/m2 or BMI ≥24 kg/m2 plus at least one weight-related comorbidity, no diabetes, stable recent weight, and willingness to follow study procedures are the intended participants.

Not a fit: People with type 1 or type 2 diabetes, elevated screening HbA1c or fasting glucose, obesity from other endocrine causes, or recent use of GLP‑1/GIP drugs are unlikely to be eligible or to benefit from participation in this trial.

Why it matters

Potential benefit: If successful, HDM1005 could help non-diabetic adults achieve clinically meaningful weight loss and improve weight-related health risks.

How similar studies have performed: Other once-weekly incretin-based agents (for example, GLP‑1 and dual GIP/GLP‑1 drugs) have shown substantial weight loss in phase 3 trials, but HDM1005 itself is a novel agent whose efficacy and safety in this population remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Male or female, aged ≥18 years at the time of signing informed consent.
2. BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.
3. A self-reported change in body weight no more than 5% within 90 days before screening.
4. Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Have type 1 diabetes mellitus (T1DM) or T2DM.
2. Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
3. Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
4. Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
5. Use of hypoglycemic drugs within 3 months prior to screening.
6. History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
7. Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
8. PHQ questionnaire ≥ 15 points at screening or randomization.
9. Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
10. Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
11. History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
12. History of severe cardiovascular or cerebrovascular diseases within the past six months.
13. History of alcohol and drug abuse at screening.
14. The participant may be allergic to ingredients in the study drug or drugs of the same class.
15. Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.
16. The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.

Where this trial is running

Shanghai

• Zhongshan Hoapital — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Xiaoying Li — Shanghai Zhongshan Hospital
• Study coordinator: Hui Qiao

Conditions: Obesity & Overweight