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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Drug: HDM1005 1; Drug: HDM1005 2; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 825
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hui Qiao; Phone Number: +86 0571-89908523; Email: qiaohui@eastchinapharm.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Zhongshan Hoapital
    • Contact: Xiaoying Li; Phone Number: +86 021-64041990; Email: Xiaoying_li@Hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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.
Experimental: HDM1005 Cohort 1	Drug: HDM1005 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.
Experimental: HDM1005 Cohort 2	Drug: HDM1005 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary outcome	The percentage change in body weight from baseline to week 40	week 40
Co-primary outcome	Proportion of subjects with body weight reduction ≥ 5% at Week 40.	week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary outcome	The proportion of participants reaching a body weight loss of at least 10% and 15% at week 40	week 40
secondary outcome	Change in waist circumference, body weight and BMI at week 40	week 40
secondary outcome	Change in waist circumference, body weight and BMI at week 52	week 52
secondary outcome	Change in systolic blood pressure (SBP), diastolic blood pressure (DBP) and lipids at week 40	week 40
secondary outcome	Change in SBP, DBP and lipids at week 52	week 52
safety outcome	the incidence of adverse events	week 52
patient report outcome	36-Item Short Form Health Survey, Version 2 questionnaire (scores range from 0 to 100, with higher scores indicating better health status) after administration for 52 weeks.	week 52
Immunogenicity outcome	ADA and NAb	week 52

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xiaoying Li, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 13, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HDM1005-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No