GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

—

Primary endpoints

•Cmax of HRS-7535(Cmax)•Area under the concentration curve from time 0 to the last quantifiable•Area under the concentration curve from time 0 to extrapolated infinite time

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

NCT IDNCT06961643

Org study IDHRS-7535-109

Timeline

Milestones

Study first posted2025-05-08actual

Study start2025-06-05actual

Primary completion2026-01-22actual

Study completion2026-01-22actual

Last update posted2026-03-02actual

Assets

Investigational agents

KAI-7535 / HRS-7535

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (8)

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.