← Trials/Trial dossier/NCT06613763
A Study of RAY1225 in Participants With Impaired Kidney Function
Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function
Lead sponsor
Asset
RAY1225
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
32
actual
Study population
Healthy volunteers, Renal impairment
Key I/E criterion
•BMI 18-28
Primary endpoints
•AUC of RAY1225•PK: Maximum Concentration 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. Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
Participants with normal renal function only:
3. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant;
4. Glomerular filtration rate (GFR)≥ 90 mL/min and <130 mL/min ;
5. Age, BMI, and sex comparable to those of subjects of renal impairment;
Participants with severe renal impairment only:
6. Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months);
Exclusion criteria
1. Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds;
2. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
3. Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months or donated blood or bleeding profusely (> 200 mL) in the 1 months;
4. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
5. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
Participants with severe renal impairment only:
6. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
7. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
8. New York heart association (NYHA) class III or IV congestive heart failure
9. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;
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 Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
Time frame:Baseline through Day 43
concentration, descriptive
PK: Maximum Concentration of RAY1225
Time frame:Baseline through Day 43
concentration, descriptive
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
Time frame:Baseline through Day 43
descriptive
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.