← Trials/Trial dossier/NCT07331389
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-∞]•Cmax•AUC[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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsAUC[0-∞]
Time frame:through study completion, an average of 11 weeks
AUC₀–∞
concentration, descriptive
Cmax
Time frame:through study completion, an average of 11 weeks
Cmax
concentration, descriptive
AUC[0-t]
Time frame:through study completion, an average of 11 weeks
AUC₀–∞
concentration, descriptive
PK parameter of HDM1002
Time frame:through study completion, an average of 11 weeks
descriptive
other PK parameters
Time frame:through study completion, an average of 11 weeks
descriptive
Adverse events (AEs)
Time frame:through study completion, an average of 11 weeks
Treatment-emergent AEs (any)
event count, event
Provenance
Sources
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.