Overweight SubjectPhase 1NCT07331389
A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
A Phase 1 study testing Metformin, Empagliflozin and Midazolam in people with Overweight Subject and Healthy Subjects, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight Subject, Healthy Subjects
- What is being tested?
- Metformin, Empagliflozin and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2025to 13 Jun 2026
- 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
- 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.
- Age range of 18-45 years old (including range), no limit to gender.
- 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).
Who cannot join
- 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.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis attack within 3 months prior to screening.
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening
- 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.
- 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
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- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
- During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
- Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
- History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
- Presence of clinically significant ECG results judged by the investigator at screening.
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, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
Yan Gao Ms, +86-0571-89918267, cxygaoyan@eastchinapharm.com
About this study
Official title: 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
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
- Being tested
- Metformin, Empagliflozin, Midazolam, Valsartan, Warfarin
- Keywords
- HDM1002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Administered orally
EmpagliflozinDrug
Single dose; Administered orally
MidazolamDrug
Single dose; Administered orally
ValsartanDrug
Single dose; Administered orally
WarfarinDrug
Single dose; Administered orally
HDM1002Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin) Receives: Drug: Metformin; Drug: Empagliflozin; Drug: Midazolam; Drug: Valsartan; Drug: Warfarin; Drug: HDM1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC[0-∞]
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞
Measured: through study completion, an average of 11 weeks
Cmax
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration
Measured: through study completion, an average of 11 weeks
AUC[0-t]
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour
Measured: through study completion, an average of 11 weeks
Secondary outcomes (3)
PK parameter of HDM1002
PK parameter of HDM1002 including Tmax, T1/2, CL/F, Vz/F, MRT, etc
Measured: through study completion, an average of 11 weeks
other PK parameters
Other PK parameters of metformin, empagliflozin, midazolam, valsartan, warfarin: Tmax, T1/2, CL/F, Vz/F, MRT, etc
Measured: through study completion, an average of 11 weeks
Adverse events (AEs)
Number of subjects reporting AEs
Measured: through study completion, an average of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start24 Sep 2025
- Primary completion12 Jan 2026 (estimated)
- Study completion13 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight SubjectStudies 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
- 111 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331389
- Sponsor's protocol ID
- HDM1002-111
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Jan 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 9 Jan 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 Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT07331389
- Acronym / sponsor ID
- HDM1002-111
- Conditions
- Overweight Subject, Healthy Subjects
- Keywords
- HDM1002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 12 Jan 2026 (estimated)
- Study completion
- 13 Jun 2026 (estimated)
- First posted
- 9 Jan 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: Metformin, Drug: Empagliflozin, Drug: Midazolam, Drug: Valsartan, Drug: Warfarin, Drug: HDM1002Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
- Age range of 18-45 years old (including range), no limit to gender.
- 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).
Key exclusion criteria (11 listed)
- 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.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis attack within 3 months prior to screening.
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening
- 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.
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 |
|---|---|---|
| MetforminAdministered orally | Drug | experimental arm |
| EmpagliflozinSingle dose; Administered orally | Drug | experimental arm |
| MidazolamSingle dose; Administered orally | Drug | experimental arm |
| ValsartanSingle dose; Administered orally | Drug | experimental arm |
| WarfarinSingle dose; Administered orally | Drug | experimental arm |
| HDM1002Administered orally | Drug | experimental arm |
Primary outcome
AUC[0-∞]
Time frame: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞
Cmax
Time frame: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration
AUC[0-t]
Time frame: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour
3 secondary outcomes
PK parameter of HDM1002
Time frame: through study completion, an average of 11 weeks
other PK parameters
Time frame: through study completion, an average of 11 weeks
Adverse events (AEs)
Time frame: through study completion, an average of 11 weeks
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 9 Jan 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 Metformin, Empagliflozin and Midazolam in people with Overweight Subject and Healthy Subjects, 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Jan 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?
AUC[0-∞] (time frame: through study completion, an average of 11 weeks). The study lists 3 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 9 Jan 2026.