← Trials/Trial dossier/NCT07331389

RecruitingPhase 1

A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin

A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

111

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 24-35

Primary endpoints

AUC[0-∞]CmaxAUC[0-t]

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 IDNCT07331389
Org study IDHDM1002-111

Timeline

Milestones

Study start2025-09-24actual
Study first posted2026-01-09actual
Last update posted2026-01-09actual
Primary completion2026-01-12estimated
Study completion2026-06-13estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.

2. Age range of 18-45 years old (including range), no limit to gender.

3. Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 kg/m2 (including cut-off values).

Exclusion criteria

1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.

2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.

3. History of acute cholecystitis attack within 3 months prior to screening.

4. Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening

5. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.

6. Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, and active pathological bleeding, etc

7. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.

8. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .

9. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.

10. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.

11. Presence of clinically significant ECG results judged by the investigator at screening.

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

AUC[0-∞]

Time frame:through study completion, an average of 11 weeks

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:through study completion, an average of 11 weeks

Cmax

concentration, descriptive

Primary/protocol endpoint

AUC[0-t]

Time frame:through study completion, an average of 11 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK parameter of HDM1002

Time frame:through study completion, an average of 11 weeks

descriptive

Secondary/protocol endpoint

other PK parameters

Time frame:through study completion, an average of 11 weeks

descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:through study completion, an average of 11 weeks

Treatment-emergent AEs (any)

event count, event

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.