OverweightPhase 1NCT07502001
Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
A Phase 1 study testing Acetaminophen, Metformin and Warfarin in people with Overweight and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Acetaminophen, Metformin and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2026to 2 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei
Mengxia Zhang, +86 15524433179, zhangmengxia@eastchinapharm.com
About this study
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
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.
- Conditions
- Overweight, Obesity
- Being tested
- Acetaminophen, Metformin, Warfarin, Atorvastatin, Digoxin
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Single dose; Administered orally
MetforminDrug
Single dose; Administered orally
WarfarinDrug
Single dose; Administered orally
AtorvastatinDrug
Single dose; Administered orally
DigoxinDrug
Single dose; Administered orally
HDM1005 injectionDrug
Subcutaneous injection QW
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Acetaminophen; Drug: Metformin; Drug: Warfarin; Drug: Atorvastatin; Drug: Digoxin; Drug: HDM1005 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ∞
Measured: Up to Day 115
Maximum observed concentration (Cmax)
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration
Measured: 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
Measured: Up to Day 115
Time of maximum observed concentration (Tmax)
PK parameter of Acetaminophen: Time of maximum observed concentration
Measured: Up to Day 115
Secondary outcomes (5)
Adverse events (AEs)
Number of subjects reporting AEs
Measured: Up to Day 115
Apparent volume of distribution (Vz/F)
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin
Measured: Up to Day 115
Time of maximum observed concentration (Tmax)
PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin
Measured: Up to Day 115
Maximum observed concentration (Cmax)
PK parameter of HDM1005
Measured: Up to Day 115
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]
PK parameter of HDM1005
Measured: Up to Day 115
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start8 Apr 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502001
- Sponsor's protocol ID
- HDM1005-104
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07502001
- Acronym / sponsor ID
- HDM1005-104
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Acetaminophen, Drug: Metformin, Drug: Warfarin, Drug: Atorvastatin, Drug: Digoxin, Drug: HDM1005 injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenSingle dose; Administered orally | Drug | Treatment group |
| MetforminSingle dose; Administered orally | Drug | Treatment group |
| WarfarinSingle dose; Administered orally | Drug | Treatment group |
| AtorvastatinSingle dose; Administered orally | Drug | Treatment group |
| DigoxinSingle dose; Administered orally | Drug | Treatment group |
| HDM1005 injectionSubcutaneous injection QW | Drug | Treatment group |
Primary outcome
Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)]
Time frame: Up to Day 115
PK parameter of Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to ∞
Maximum observed concentration (Cmax)
Time frame: Up to Day 115
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]
Time frame: Up to Day 115
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to t
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 115
PK parameter of Acetaminophen: Time of maximum observed concentration
5 secondary outcomes
Adverse events (AEs)
Time frame: Up to Day 115
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 115
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 115
Maximum observed concentration (Cmax)
Time frame: Up to Day 115
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]
Time frame: Up to Day 115
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetaminophen, Metformin and Warfarin in people with Overweight and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)] (time frame: Up to Day 115). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.