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RecruitingPhase 3

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

Asset

HDM1005

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

825

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoints

Primary outcomeCo-primary outcome

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07279194
Org study IDHDM1005-301

Timeline

Milestones

Study start2025-10-14actual
Study first posted2025-12-12actual
Last update posted2025-12-12actual
Primary completion2026-09-20estimated
Study completion2026-12-13estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
8
Safety / tolerability / PK
2

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

safety outcome

Time frame:week 52

descriptive

Secondary/protocol endpoint

Immunogenicity outcome

Time frame:week 52

descriptive

Other (unclassified)

8 endpoints
Primary/protocol endpoint/low confidence

primary outcome

Time frame:week 40

descriptive

Primary/protocol endpoint/low confidence

Co-primary outcome

Time frame:week 40

descriptive

Secondary/protocol endpoint/low confidence

secondary outcome

Time frame:week 40

descriptive

Secondary/protocol endpoint/low confidence

secondary outcome

Time frame:week 40

descriptive

Secondary/protocol endpoint/low confidence

secondary outcome

Time frame:week 52

descriptive

Secondary/protocol endpoint/low confidence

secondary outcome

Time frame:week 40

descriptive

Secondary/protocol endpoint/low confidence

secondary outcome

Time frame:week 52

descriptive

Secondary/protocol endpoint/low confidence

patient report outcome

Time frame:week 52

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.