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Clinical Trial NCT07502001 for Overweight, Obesity is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin Phase 1 42
Clinical Trial NCT07502001 is designed to study Treatment for Overweight, Obesity. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on April 8, 2026 until the study accrues 42 participants. Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., this study is expected to complete by June 2, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
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.
Official Title
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
Conditions
OverweightObesityOther Study IDs
- HDM1005-104
NCT ID Number
Start Date (Actual)
2026-04-08
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-06-02
Enrollment (Estimated)
42
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTreatment group | Acetaminophen Single dose; Administered orally Metformin Single dose; Administered orally Warfarin Single dose; Administered orally Atorvastatin Single dose; Administered orally Digoxin Single dose; Administered orally HDM1005 injection Subcutaneous injection QW |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)] | PK parameter of Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to ∞ | Up to Day 115 |
Maximum observed concentration (Cmax) | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration | Up to Day 115 |
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to t | Up to Day 115 |
Time of maximum observed concentration (Tmax) | PK parameter of Acetaminophen: Time of maximum observed concentration | Up to Day 115 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Adverse events (AEs) | Number of subjects reporting AEs | Up to Day 115 |
Apparent volume of distribution (Vz/F) | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin | Up to Day 115 |
Time of maximum observed concentration (Tmax) | PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin | Up to Day 115 |
Maximum observed concentration (Cmax) | PK parameter of HDM1005 | Up to Day 115 |
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | PK parameter of HDM1005 | Up to Day 115 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- 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).
- Female participants who are breastfeeding or pregnant.
- 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)
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.No contact data.
1 Study Locations in 1 Countries
The Second Affiliated Hospital of Anhui Medical University, Hefei, China
Mengxia Zhang, Contact, +86 15524433179, [email protected]