Type 2 DiabetesPhase 1NCT06654960

Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

A Phase 1 study testing HRS9531 injection and Metformin Hydrochloride tablets 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 pharmacokinetics of metformin in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes
What is being tested?: HRS9531 injection and Metformin Hydrochloride tablets
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 5 Nov 2024to 26 Dec 2024
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
Men only
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 ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);
HbA1c<6.0%.

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;
Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)
Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
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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Allergic constitution includes severe drug allergy or history of drug allergy;
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;
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, Single Cohort, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Pharmacokinetics of Metformin in Healthy Subjects

The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.

Conditions: Type 2 Diabetes
Being tested: HRS9531 injection, Metformin Hydrochloride tablets
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.

HRS9531 injectionDrug
HRS9531 injection single dose.
Metformin Hydrochloride tabletsDrug
Metformin Hydrochloride tablets 500mg.

Study groups in NCT06654960
Study group	Role	What they receive
Single arm	Experimental	Not described Receives: Drug: HRS9531 injection; Drug: Metformin Hydrochloride tablets

What is being measured

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

Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days.
Measured: Start of treatment up to 12 hours.

Secondary outcomes (15)

Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Maximum concentration (Cmax) of metformin after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Terminal half-life (t1/2) of metformin after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Clearance (CL/F) of metformin after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment.
Measured: Start of Treatment up to 30 hours.
Time to maximum concentration (Tmax) of HRS9531.
Measured: Start of Treatment up to 504 hours.
Maximum concentration (Cmax) of HRS9531.
Measured: Start of Treatment up to 504 hours.
Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration (AUC0-t).
Measured: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf).
Measured: Start of Treatment up to 504 hours.
Terminal half-life (t1/2) of HRS9531.
Measured: Start of Treatment up to 504 hours.
Clearance (CL/F) of HRS9531.
Measured: Start of Treatment up to 504 hours.
Apparent volume of distribution (VzF) of HRS9531.
Measured: Start of Treatment up to 504 hours.
Incidence and severity of adverse events.
Measured: Screening period up to 42 days.

Timeline

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

5 Nov 202426 Dec 2024

First posted23 Oct 2024
Study start5 Nov 2024
Primary completion26 Dec 2024
Study completion26 Dec 2024

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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06654960
Sponsor's protocol ID: HRS9531-106
Status last verified: Oct 2024
First submitted: 21 Oct 2024
Last updated: 7 Jan 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Open-label, Single Cohort, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Pharmacokinetics of Metformin in Healthy Subjects
ClinicalTrials.gov ID: NCT06654960
Acronym / sponsor ID: HRS9531-106
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 5 Nov 2024 (actual)
Primary completion: 26 Dec 2024 (actual)
Study completion: 26 Dec 2024 (actual)
First posted: 23 Oct 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 pharmacokinetics of metformin 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
Single arm	Experimental	Drug: HRS9531 injection, Drug: Metformin Hydrochloride tablets

Who may qualify

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

Key inclusion criteria (4 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 ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);
HbA1c<6.0%.

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;
Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)
Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
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
HRS9531 injectionHRS9531 injection single dose.	Drug	Single arm
Metformin Hydrochloride tabletsMetformin Hydrochloride tablets 500mg.	Drug	Single arm

Primary outcome

Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days.
Time frame: Start of treatment up to 12 hours.

15 secondary outcomes

Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Maximum concentration (Cmax) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Terminal half-life (t1/2) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Clearance (CL/F) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment.
Time frame: Start of Treatment up to 30 hours.
Time to maximum concentration (Tmax) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Maximum concentration (Cmax) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration (AUC0-t).
Time frame: Start of Treatment up to 30 hours.
Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf).
Time frame: Start of Treatment up to 504 hours.
Terminal half-life (t1/2) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Clearance (CL/F) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Apparent volume of distribution (VzF) of HRS9531.
Time frame: Start of Treatment up to 504 hours.
Incidence and severity of adverse events.
Time frame: Screening period up to 42 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 7 Jan 2025.
Individual participant dataSharing planned: Undecided

Related trials for Type 2 Diabetes

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Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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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Not yet recruiting
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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 HRS9531 injection and Metformin Hydrochloride tablets 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 4 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 7 Jan 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 concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days. (time frame: Start of treatment up to 12 hours.). 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 NCT06654960.

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 7 Jan 2025.