DelfaGLP-1 Atlas

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UnknownPhase 2

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

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

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

180

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Body weight, % change

Identifiers

Registered as

NCT IDNCT06500299
Org study IDHDM1002-201

Timeline

Milestones

Study first posted2024-07-15actual
Study start2024-07-15estimated
Last update posted2024-07-15actual
Primary completion2024-10-30estimated
Study completion2024-11-30estimated

Assets

Investigational agents

HDM1002

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female subjects between 18 and 65 years of age (inclusive).
•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. Impaired fasting glucose or impaired glucose tolerance

3. Dyslipidemia

4. Obstructive sleep apnea syndrome

•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 (16)

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

Safety / tolerability / PK
6
Weight & body composition
4
Glycemic / diabetes
4
Cardiometabolic biomarkers
2

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percentage Change From Baseline in Body Weight at Week 12

Time frame:Baseline, Week 12

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change From Baseline in Body Weight at Week 2, Week 4, Week 6, Week 8, Week 10

Time frame:Baseline, Week 2, Week 4, Week 6, Week 8, Week 10

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12

Time frame:Baseline, Week 12

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI), And Waist Circumference

Time frame:Baseline, Week 12

change from baseline, improvement

componentsBMI, change, Waist circumference, change

Glycemic / diabetes

4 endpoints
Other/protocol endpoint/low confidence

Change From Baseline in Fasting Insulin

Time frame:Time Frame: Baseline, Week 12

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Fasting plasma Glucose

Time frame:Time Frame: Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Change From Baseline in Fasting C-Peptide,

Time frame:Time Frame: Baseline, Week 12

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in HbA1c at Week 12

Time frame:Time Frame: Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Percentage change from baseline in fasting lipid profile (total cholesterol, low density lipoprotein [LDL] cholesterol, high density lipoprotein [HDL] cholesterol, non HDL cholesterol, lipoprotein (a) (Lp[a]), triglycerides)

Time frame:Baseline, Week 12

percent change from baseline, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, Non-HDL cholesterol, change, Triglycerides, change, lipoprotein(a)

Secondary/protocol endpoint

Change From Baseline in Systolic and Diastolic Blood Pressure

Time frame:Baseline, Week 12

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram and Number of Participants With Treatment Emergent Adverse Events

Time frame:Through Week 16]

Treatment-emergent AEs (any)

descriptive

componentsTreatment-emergent AEs (any)

Other/protocol endpoint

Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

Time frame:Day 1, Day 15, Day 29, Day 57 and Day 85

AUC₀–∞

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

Time frame:Day 1, Day 15, Day 29, Day 57 and Day 85

Cmax

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

Time frame:Day 1, Day 15, Day 29, Day 57 and Day 85

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

Time frame:Day 1, Day 15, Day 29, Day 57 and Day 85

Tmax

descriptive

Other/protocol endpoint

Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

Time frame:Day 1, Day 15, Day 29, Day 57 and Day 85

AUC₀–∞

concentration, 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.