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Recruiting Phase 1 NCT07331389

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

Trial Parameters

Condition Overweight Subject
Sponsor Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 111
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2025-09-24
Completion 2026-01-12
Interventions
MetforminEmpagliflozinMidazolam

Brief Summary

The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated

Eligibility Criteria

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 investig

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