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CompletedPhase 1

A Study of RAY1225 in Participants With Impaired Kidney Function

Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function

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 RAY1225PK: 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

NCT IDNCT06613763
Org study IDRAY1225-24-06

Timeline

Milestones

Study start2024-09-11actual
Study first posted2024-09-26actual
Primary completion2025-01-10actual
Study completion2025-01-20actual
Last update posted2025-03-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

Pharmacokinetics (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

Primary/protocol endpoint

PK: Maximum Concentration of RAY1225

Time frame:Baseline through Day 43

concentration, descriptive

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.