Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · May 6, 2025

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ClinConnect Summary

This clinical trial is looking at a new drug called HRS-7535 to see how it moves through the body and how safe it is for people with liver issues compared to those with normal liver function. The study will focus on adults aged 18 to 70, both men and women, who are healthy or have mild to moderate liver problems. Participants must be able to understand the study and give their written consent to join.

If you’re considering participating, you should be aware that certain conditions may exclude you, such as allergies to the study drug, smoking more than 10 cigarettes a day, or heavy drinking. Participants will need to weigh at least 50 kg (about 110 pounds) for men and 45 kg (about 99 pounds) for women and have a specific body mass index (BMI) range. While the trial is not yet recruiting, if eligible, you can expect to help researchers learn more about how HRS-7535 affects people differently based on their liver health, which could contribute to better diabetes treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
• • 2. Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
• • 3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18\~32 kg/m2 (including the threshold).
• Exclusion Criteria:
• • 1. In the judgment of the investigator, may be allergic to the study drug or its components.
• • 2. Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
• • 3. Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
• • 4. History of drug or substance abuse, or a positive urine drug test at screening.
• • 5. Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
• • 6. Individuals with a history of severe hypoglycemia.
• • 7. Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.