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Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects
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
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
57
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 24-35•HbA1c ≤6%
Primary endpoints
•AUC of acetaminophen•Maximum observed acetaminophen concentration•Time of maximum observed acetaminophen concentration
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 ≥60 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
4. HbA1c<6.0%;
5. 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.
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. Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
3. History of disease that increases the risk of bleeding;
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. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
8. Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
9. History of hypoglycaemia;
10. History of syncope or vasovagal episodes, difficulty with blood collection, or an inability to tolerate venipuncture;
11. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Endpoints (26)
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
26 endpointsArea under the acetaminophen plasma concentration-time curve
Time frame:From time 0 to 24 hours after a single dose.
AUC₀–∞
concentration, descriptive
Maximum observed acetaminophen concentration
Time frame:From time 0 to 24 hours after a single dose.
Cmax
concentration, descriptive
Time of maximum observed acetaminophen concentration
Time frame:From time 0 to 24 hours after a single dose.
Tmax
descriptive
Area under the metformin plasma concentration-time curve
Time frame:From time 0 to 12 hours after the last of 7 repeated doses.
AUC₀–∞
concentration, descriptive
Area under the S-warfarin plasma concentration-time curve
Time frame:From time 0 to 168 hours after a single dose.
AUC₀–∞
concentration, descriptive
Area under the atorvastatin plasma concentration-time curve
Time frame:From time 0 to 72 hours after a single dose.
AUC₀–∞
concentration, descriptive
Area under the digoxin plasma concentration-time curve
Time frame:From time 0 to 120 hours after a single dose.
AUC₀–∞
concentration, descriptive
Area under the concentration versus time curve of acetaminophen from 0 to infinity
Time frame:Start of treatment up to 168 hours.
AUC₀–∞
concentration, descriptive
Apparent volume of distribution of acetaminophen
Time frame:Start of treatment up to 168 hours.
descriptive
Time of maximum observed metformin concentration after 3.5 days of treatment
Time frame:Start of Treatment up to 30 hours.
Tmax
descriptive
Clearance of metformin after 3.5 days of treatment
Time frame:Start of Treatment up to 30 hours.
descriptive
Apparent volume of distribution of metformin after 3.5 days of treatment
Time frame:Start of Treatment up to 30 hours.
descriptive
Time of maximum observed S-warfarin concentration
Time frame:Start of Treatment up to 168 hours.
Tmax
descriptive
Clearance of S-warfarin
Time frame:Start of Treatment up to 168 hours.
descriptive
Apparent volume of distribution of S-warfarin
Time frame:Start of Treatment up to 168 hours.
descriptive
Time of maximum observed atorvastatin (and its active metabolites) concentration
Time frame:Start of Treatment up to 72 hours.
Tmax
descriptive
Clearance of atorvastatin (and its active metabolites)
Time frame:Start of Treatment up to 72 hours.
descriptive
Time of maximum observed digoxin concentration
Time frame:Start of Treatment up to 120 hours.
Tmax
descriptive
Maximum observed digoxin concentration
Time frame:Start of Treatment up to 120 hours.
Cmax
concentration, descriptive
Clearance of digoxin
Time frame:Start of Treatment up to 120 hours.
descriptive
Apparent volume of distribution of digoxin
Time frame:Start of Treatment up to 120 hours.
descriptive
Time of maximum observed HRS9532 concentration
Time frame:Start of Treatment up to 168 hours.
Tmax
descriptive
Maximum observed HRS9531 concentration
Time frame:Start of Treatment up to 168 hours.
Cmax
concentration, descriptive
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.
AUC₀–∞
concentration, descriptive
Area under the concentration versus time curve of HRS9531 from 0 to infinity
Time frame:Start of Treatment up to 168 hours.
AUC₀–∞
concentration, descriptive
Incidence and severity of adverse events
Time frame:Screening period up to 117 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.