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Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects
A Single Center, Open-label, Single Cohort, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Pharmacokinetics of Metformin in Healthy Subjects
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
20
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 20-30•HbA1c ≤6%•Male
Primary endpoint
•AUC of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
2. Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
3. Body weight ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);
4. HbA1c<6.0%.
Exclusion criteria
1. 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;
2. Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)
3. Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
4. Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
6. 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;
7. Allergic constitution includes severe drug allergy or history of drug allergy;
8. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
9. Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
10. History of hypoglycaemia;
11. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
16 endpointsArea 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.
AUC₀–∞
concentration, descriptive
Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment.
Time frame:Start of Treatment up to 30 hours.
Tmax
descriptive
Maximum concentration (Cmax) of metformin after 3.5 days of treatment.
Time frame:Start of Treatment up to 30 hours.
Cmax
concentration, descriptive
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.
AUC₀–∞
concentration, descriptive
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.
AUC₀–∞
concentration, descriptive
Terminal half-life (t1/2) of metformin after 3.5 days of treatment.
Time frame:Start of Treatment up to 30 hours.
Half-life
descriptive
Clearance (CL/F) of metformin after 3.5 days of treatment.
Time frame:Start of Treatment up to 30 hours.
descriptive
Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment.
Time frame:Start of Treatment up to 30 hours.
descriptive
Time to maximum concentration (Tmax) of HRS9531.
Time frame:Start of Treatment up to 504 hours.
Tmax
descriptive
Maximum concentration (Cmax) of HRS9531.
Time frame:Start of Treatment up to 504 hours.
Cmax
concentration, descriptive
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.
AUC₀–∞
concentration, descriptive
Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf).
Time frame:Start of Treatment up to 504 hours.
AUC₀–∞
concentration, descriptive
Terminal half-life (t1/2) of HRS9531.
Time frame:Start of Treatment up to 504 hours.
Half-life
descriptive
Clearance (CL/F) of HRS9531.
Time frame:Start of Treatment up to 504 hours.
descriptive
Apparent volume of distribution (VzF) of HRS9531.
Time frame:Start of Treatment up to 504 hours.
descriptive
Incidence and severity of adverse events.
Time frame:Screening period up to 42 days.
Treatment-emergent AEs (any)
descriptive, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.