← Trials/Trial dossier/NCT06577415
A Study of RAY1225 in Participants With Impaired Liver Function
A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment
Lead sponsor
Asset
RAY1225
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
1
Enrollment
24
estimated
Study population
Healthy volunteers, Hepatic impairment
Key I/E criteria
•BMI ≥20•eGFR ≥60•Healthy volunteers
Primary endpoints
•AUC of Drug From Zero To Infinity (AUC[0-∞]) of RAY1225•PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
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. Participant must be ≥ 18 to ≤ 75 years;
2. BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
4. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;
5. eGFR ≥ 60 mL/min/1.73 m2;
Participants with Normal Hepatic Function Only:
6. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;
Participants with hepatic impairment only:
7. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.
Exclusion criteria
1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
2. QTcF> 450ms;
3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;
4. Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months;
5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;
6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;
7. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
Participants with Normal Hepatic Function Only:
8. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
Participants with Hepatic Impairment Only:
9. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
10. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.
Endpoints (3)
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
3 endpointsPharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
Time frame:DAY1~43
concentration, descriptive
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
Time frame:DAY1~43
concentration, descriptive
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time frame:DAY1~43
event count, 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.