NCT07502001Not yet recruitingPhase 1
Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Influence of HDM1005 on Gastric Emptying and Drug-Drug Interaction of HDM1005 and Metformin, Atorvastatin, Warfarin, and Digoxin in Overweight/Obese Adult Chinese Subjects
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 8 Apr 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07502001
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 42
- From 8 Apr 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of an acute episode of cholecystitis within 3 months prior to screening.
- Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.
- Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose.
- Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives).
- Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
Other illness
- Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)
Other
- Female participants who are breastfeeding or pregnant.
Who the study is looking for
- Aged between 18 and 45 years (inclusive), regardless of gender.
- Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight \[kg\]/height² \[m²\]) within the range of 24.0 to 35.0 kg/m² (inclusive).
- In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.
- Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital Of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.