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

NCT07279194 | Recruiting Phase 3

• 1 other identifier: HDM1005-301
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• secondary outcome

  week 40

• secondary outcome

  week 40

• secondary outcome

  week 52

• secondary outcome

  week 40

• secondary outcome

  week 52

Study Arms (3)

HDM1005 Cohort 1

EXPERIMENTAL

Drug: HDM1005 1

HDM1005 Cohort 2

EXPERIMENTAL

Drug: HDM1005 2

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HDM1005 2 DRUG

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.

HDM1005 Cohort 2

Placebo DRUG

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.

Placebo

HDM1005 1 DRUG

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.

HDM1005 Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male or female aged 18 years or above at the time of signing the informed consent
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years at the time of signing informed consent.
• 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.
• A self-reported change in body weight no more than 5% within 90 days before screening.
• 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.

You may not qualify if:

• Have type 1 diabetes mellitus (T1DM) or T2DM.
• Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
• Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
• 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.
• Use of hypoglycemic drugs within 3 months prior to screening.
• History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
• Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
• PHQ questionnaire ≥ 15 points at screening or randomization.
• Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
• 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).
• History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
• History of severe cardiovascular or cerebrovascular diseases within the past six months.
• History of alcohol and drug abuse at screening.
• The participant may be allergic to ingredients in the study drug or drugs of the same class.
• Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongshan Hoapital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoying Li

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Qiao

CONTACT

+86 0571-89908523; qiaohui@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

CN (1)