How HDM1002 interacts with metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, interventional study is designed to characterize drug-drug interactions between HDM1002 and five commonly used medications and to collect safety and tolerability data when the drugs are given alone or together. Eligible participants are adults aged 18–45 with BMI 24.0–35.0 kg/m2 and otherwise in good general health. The protocol will include controlled dosing and timed pharmacokinetic sampling to measure changes in drug levels and monitoring for adverse events. Results will inform safe dosing and co-prescribing recommendations for future trials and clinical use.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.