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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 65

HRS9531 PK in adults with different liver function

Official title: A Multi-center, Single-dose, Parallel-group, Open-label Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function

Run by Fujian Shengdi Pharmaceutical Co., Ltd. · NCT07540754 · Data updated 2026-11-12

This Phase 1 study tests how HRS9531 behaves in the body and whether it is safe in people with mild, moderate liver impairment and those with normal liver function.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment24 (estimated)
SponsorFujian Shengdi Pharmaceutical Co., Ltd.
Industry-sponsored
Locations1 site (Zhengzhou, Henan)
StatusRecruiting
StartedMay 26, 2026
Main results expectedJanuary 2027
Study endsFebruary 2027
Registry record updatedJune 1, 2026
Trial IDNCT07540754 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with diabetes mellitus and weight loss considerations, across mild/moderate hepatic impairment and normal liver function.

Probably not a fit

Patients with severe hepatic impairment or those outside the eligibility criteria may not benefit from this PK study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating the pharmacokinetics and safety of HRS9531 Injection in adults with varying hepatic function. The trial compares PK profiles between participants with mild or moderate hepatic impairment and those with normal hepatic function. Key goals are to characterize absorption, distribution, metabolism, and excretion, and to monitor safety signals in all groups. Enrollment targets adults aged 18–65, with specific weight considerations and contraception requirements. The study is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. and conducted at The First Affiliated Hospital of Zhengzhou University in Zhengzhou, Henan.

Why it matters

Potential benefit: If successful, participants may experience a clearer understanding of the drug’s behavior in the body across liver function levels, informing future dosing.

How similar studies have gone: PK studies of similar agents in liver impairment have shown variable metabolism but can meaningfully inform dosing in subgroups.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial content, procedures, and potential adverse reactions; they must also be willing and able to comply with the protocol requirements to complete the study.
2. Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use contraceptive measures and refrain from egg donation from the time of signing the informed consent form until 2 months after the last dose of the study drug; male participants with partners of childbearing potential must agree to use contraceptive measures and refrain from sperm donation from the time of signing the informed consent form until 2 months after the last dose of the study drug.
3. Aged 18 to 65 years (inclusive), both male and female.
4. Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to 40.0 kg/m² (inclusive).

Exclusion Criteria:

1. Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a clinical study or within 5 half-lives of the investigational drug (whichever is longer).
2. Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.
3. Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
4. Drug abusers or those with a positive urine drug screening test.
5. Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or receipt of a blood transfusion within 3 months prior to dosing.
6. Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.
7. Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia).
8. History of severe hypoglycemia.
9. Previous significant gastric emptying abnormalities or factors affecting gastric emptying (e.g., history of gastric bypass surgery, pyloric stenosis), or severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or have undergone gastrointestinal surgery (excluding surgeries with no significant impact on gastrointestinal motility, such as removal of gastrointestinal polyps, appendectomy, hemorrhoidectomy, etc.).
10. Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.

Where it's running

  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.