Type 2 DiabetesPhase 1NCT06723691

Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

A Phase 1 study testing Acetaminophen, Metformin and Warfarin in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes
What is being tested?: Acetaminophen, Metformin and Warfarin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteChina
Study dates: 18 Dec 2024to 9 Jun 2025
Phase: Phase 1
Are there results?: None posted in the registry

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

Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
Body weight ≥60 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
HbA1c<6.0%;
The subjects have no plans to have children and voluntarily take effective contraceptive measures from the time of signing the informed consent to 2 months after the last medication, and have no plans to donate eggs/sperm; the pregnancy test of female subjects with fertility must be negative.

Who cannot join

Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
History of disease that increases the risk of bleeding;
Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;

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Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
History of hypoglycaemia;
History of syncope or vasovagal episodes, difficulty with blood collection, or an inability to tolerate venipuncture;
The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000

Other trials in China

About this study

Official title: A Single Center, Open-label, Two Cohorts, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

The purpose of this study is to evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy subjects.

Conditions: Type 2 Diabetes
Being tested: Acetaminophen, Metformin, Warfarin, Atorvastatin, Digoxin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcetaminophenDrug
Acetaminophen
MetforminDrug
Metformin
WarfarinDrug
Warfarin
AtorvastatinDrug
Atorvastatin
DigoxinDrug
Digoxin
HRS9531Drug
HRS9531

Study groups in NCT06723691
Study group	Role	What they receive
Treatment group	Experimental	Not described Receives: Drug: Acetaminophen; Drug: Metformin; Drug: Warfarin; Drug: Atorvastatin; Drug: Digoxin; Drug: HRS9531

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the acetaminophen plasma concentration-time curve
Measured: From time 0 to 24 hours after a single dose.
Maximum observed acetaminophen concentration
Measured: From time 0 to 24 hours after a single dose.
Time of maximum observed acetaminophen concentration
Measured: From time 0 to 24 hours after a single dose.
Area under the metformin plasma concentration-time curve
Measured: From time 0 to 12 hours after the last of 7 repeated doses.
Area under the S-warfarin plasma concentration-time curve
Measured: From time 0 to 168 hours after a single dose.
Area under the atorvastatin plasma concentration-time curve
Measured: From time 0 to 72 hours after a single dose.
Area under the digoxin plasma concentration-time curve
Measured: From time 0 to 120 hours after a single dose.

Secondary outcomes (19)

Area under the concentration versus time curve of acetaminophen from 0 to infinity
Measured: Start of treatment up to 168 hours.
Apparent volume of distribution of acetaminophen
Measured: Start of treatment up to 168 hours.
Time of maximum observed metformin concentration after 3.5 days of treatment
Measured: Start of Treatment up to 30 hours.
Clearance of metformin after 3.5 days of treatment
Measured: Start of Treatment up to 30 hours.
Apparent volume of distribution of metformin after 3.5 days of treatment
Measured: Start of Treatment up to 30 hours.
Time of maximum observed S-warfarin concentration
Measured: Start of Treatment up to 168 hours.
Clearance of S-warfarin
Measured: Start of Treatment up to 168 hours.
Apparent volume of distribution of S-warfarin
Measured: Start of Treatment up to 168 hours.
Time of maximum observed atorvastatin (and its active metabolites) concentration
Measured: Start of Treatment up to 72 hours.
Clearance of atorvastatin (and its active metabolites)
Measured: Start of Treatment up to 72 hours.
Time of maximum observed digoxin concentration
Measured: Start of Treatment up to 120 hours.
Maximum observed digoxin concentration
Measured: Start of Treatment up to 120 hours.
Clearance of digoxin
Measured: Start of Treatment up to 120 hours.
Apparent volume of distribution of digoxin
Measured: Start of Treatment up to 120 hours.
Time of maximum observed HRS9532 concentration
Measured: Start of Treatment up to 168 hours.
Maximum observed HRS9531 concentration
Measured: Start of Treatment up to 168 hours.
Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration
Measured: Start of Treatment up to 168 hours.
Area under the concentration versus time curve of HRS9531 from 0 to infinity
Measured: Start of Treatment up to 168 hours.
Incidence and severity of adverse events
Measured: Screening period up to 117 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 20249 Jun 2025

First posted9 Dec 2024
Study start18 Dec 2024
Primary completion9 Jun 2025
Study completion9 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Fujian Shengdi 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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06723691
Sponsor's protocol ID: HRS9531-107
Status last verified: Jun 2025
First submitted: 5 Dec 2024
Last updated: 22 Jun 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Open-label, Two Cohorts, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects
ClinicalTrials.gov ID: NCT06723691
Acronym / sponsor ID: HRS9531-107
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 Dec 2024 (actual)
Primary completion: 9 Jun 2025 (actual)
Study completion: 9 Jun 2025 (actual)
First posted: 9 Dec 2024 (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 evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy 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: HRS9531

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
Body weight ≥60 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
HbA1c<6.0%;
The subjects have no plans to have children and voluntarily take effective contraceptive measures from the time of signing the informed consent to 2 months after the last medication, and have no plans to donate eggs/sperm; the pregnancy test of female subjects with fertility must be negative.

Key exclusion criteria (11 listed)

Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
History of disease that increases the risk of bleeding;
Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;

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
AcetaminophenAcetaminophen	Drug	Treatment group
MetforminMetformin	Drug	Treatment group
WarfarinWarfarin	Drug	Treatment group
AtorvastatinAtorvastatin	Drug	Treatment group
DigoxinDigoxin	Drug	Treatment group
HRS9531HRS9531	Drug	Treatment group

Primary outcome

Area under the acetaminophen plasma concentration-time curve
Time frame: From time 0 to 24 hours after a single dose.
Maximum observed acetaminophen concentration
Time frame: From time 0 to 24 hours after a single dose.
Time of maximum observed acetaminophen concentration
Time frame: From time 0 to 24 hours after a single dose.
Area under the metformin plasma concentration-time curve
Time frame: From time 0 to 12 hours after the last of 7 repeated doses.
Area under the S-warfarin plasma concentration-time curve
Time frame: From time 0 to 168 hours after a single dose.
Area under the atorvastatin plasma concentration-time curve
Time frame: From time 0 to 72 hours after a single dose.
Area under the digoxin plasma concentration-time curve
Time frame: From time 0 to 120 hours after a single dose.

19 secondary outcomes

Area under the concentration versus time curve of acetaminophen from 0 to infinity
Time frame: Start of treatment up to 168 hours.
Apparent volume of distribution of acetaminophen
Time frame: Start of treatment up to 168 hours.
Time of maximum observed metformin concentration after 3.5 days of treatment
Time frame: Start of Treatment up to 30 hours.
Clearance of metformin after 3.5 days of treatment
Time frame: Start of Treatment up to 30 hours.
Apparent volume of distribution of metformin after 3.5 days of treatment
Time frame: Start of Treatment up to 30 hours.
Time of maximum observed S-warfarin concentration
Time frame: Start of Treatment up to 168 hours.
Clearance of S-warfarin
Time frame: Start of Treatment up to 168 hours.
Apparent volume of distribution of S-warfarin
Time frame: Start of Treatment up to 168 hours.
Time of maximum observed atorvastatin (and its active metabolites) concentration
Time frame: Start of Treatment up to 72 hours.
Clearance of atorvastatin (and its active metabolites)
Time frame: Start of Treatment up to 72 hours.
Time of maximum observed digoxin concentration
Time frame: Start of Treatment up to 120 hours.
Maximum observed digoxin concentration
Time frame: Start of Treatment up to 120 hours.
Clearance of digoxin
Time frame: Start of Treatment up to 120 hours.
Apparent volume of distribution of digoxin
Time frame: Start of Treatment up to 120 hours.
Time of maximum observed HRS9532 concentration
Time frame: Start of Treatment up to 168 hours.
Maximum observed HRS9531 concentration
Time frame: Start of Treatment up to 168 hours.
Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration
Time frame: Start of Treatment up to 168 hours.
Area under the concentration versus time curve of HRS9531 from 0 to infinity
Time frame: Start of Treatment up to 168 hours.
Incidence and severity of adverse events
Time frame: Screening period up to 117 days.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
Individual participant dataSharing planned: Undecided

Related trials for Type 2 Diabetes

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Recruiting
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 Type 2 Diabetes, run by Fujian Shengdi 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 5 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: finished, as of the sponsor's last update on 22 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the acetaminophen plasma concentration-time curve (time frame: From time 0 to 24 hours after a single dose.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06723691.

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 22 Jun 2025.