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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Overweight Subject
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Metformin	Administered orally
DRUG	Empagliflozin	Single dose; Administered orally
DRUG	Midazolam	Single dose; Administered orally
DRUG	Valsartan	Single dose; Administered orally
DRUG	Warfarin	Single dose; Administered orally
DRUG	HDM1002	Administered orally

Timeline

• Start date: 2025-09-24
• Primary completion: 2026-01-12
• Completion: 2026-06-13
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study