DelfaGLP-1 Atlas

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Not yet recruitingPhase 3

Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

780

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Identifiers

Registered as

NCT IDNCT06885021
Org study IDHDM1002-301

Timeline

Milestones

Study first posted2025-03-19actual
Last update posted2025-03-19actual
Study start2025-03-28estimated
Primary completion2026-05-30estimated
Study completion2026-06-30estimated

Assets

Investigational agents

HDM1002

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•BMI≥28 but < 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but < 28 kg/m2 with any of the following:

1. Hypertension

2. Dyslipidemia

3. Obstructive sleep apnea syndrome

4. MASH

5. Pain in the weight-bearing joints

•At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification

Exclusion criteria

•Weight change ≥5% as reported or documented.
•Previous diagnosis of type 1, type 2, or any other type of diabetes.
•Diagnosis of overweight or obesity due to other diseases or medications.
•History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
•Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
•GLP-1R agonist use within 6 months prior to signing ICF.
•Use of hypoglycemic drugs within 3 months before signing ICF.

Endpoints (5)

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.

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percentage Change From Baseline in Body Weight

Time frame:44weeks

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage Change of Participants Achieving Weight Loss ≥ 5%

Time frame:44weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15%

Time frame:44weeks

threshold achievement, improvement

components≥10% weight-loss responders, ≥15% weight-loss responders

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:44 weeks, 52 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15%

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

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.