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

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

This trial tests how the investigational drug HDM1002 affects and is affected by metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hefei)
• Trial ID: NCT07331389 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are overweight or obese adults aged 18–45 with BMI between 24.0 and 35.0 kg/m2 who are in good general health and meet the study's screening labs and exam criteria.

Not a fit: Patients with a history of medullary thyroid cancer or MEN2, recent pancreatitis or cholecystitis, recent severe or recurrent hypoglycemia, or who fall outside the age/BMI ranges are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could guide safer co-prescribing of HDM1002 with common diabetes, sedative, blood pressure, and anticoagulant medications and help avoid harmful interactions.

How similar studies have performed: Drug-drug interaction studies are a routine and informative step in drug development, but interactions specific to HDM1002 are untested and this study is exploratory.

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 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 this trial is running

Hefei

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

Conditions Overweight Subject; Healthy Subjects; HDM1002