RecruitingPhase 1

A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide

A Phase 1, Open Label, Parallel Group Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics of Ribupatide in Healthy Participants and in Participants Living With Severe Renal Impairment or End Stage Kidney Disease

Lead sponsor

Kailera

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Chronic kidney disease, End Stage Renal Disease, Obesity / overweight, Renal impairment

Eligibility highlights

•BMI ≥18.5

Primary endpoints

•Cmax of Ribupatide•Area Under Concentration Time Curve•Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07793929

Org study IDK9531-1316

Timeline

Milestones

Study first posted2026-08-31actual

Study start2026-09-08actual

Last update posted2026-10-01actual

Primary completion2028-02-08estimated

Study completion2028-02-08estimated

Assets

Investigational agents

HRS9531

Who this study enrolls

Chronic kidney diseaseEnd Stage Renal DiseaseObesity / overweightRenal impairment

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Body mass index ≥18.5 at Screening.

•Female Participants: Must not be pregnant or planning to be pregnant or breastfeeding or planning to breastfeed during the study and for at least 35 days after the study drug dose.

•Female participants: Must have a negative serum pregnancy test at Screening.

•Suitable venous access for blood sampling.

Exclusion criteria

•History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the Investigator (or delegate) to be clinically relevant.

•Abnormal thyroid-stimulating hormone at Screening.

•Any history of malignant disease including in situ cervical or prostate cancer within the last 5 years.

•History of or positive test results at the Screening Visit for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or active hepatitis C virus (HCV) infection.

•Participated in another clinical study of a study drug or investigational device within 30 days or 5 half-lives of the study drug (whichever is longer) prior to Screening.

•Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist, or glucagon receptor agonist within 3 months prior to Screening.

•Known hypersensitivity to the study drug, glucagon-like peptide-1 (GLP-1) therapies, or any of the study drug ingredients.

•Received any vaccinations within 30 days prior to Screening.

•Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days prior to the dose of study drug.

Endpoints (4)

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

4 endpoints

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Ribupatide

Time frame:Predose up to 816 hours postdose on Day 35

concentration, descriptive

Primary/protocol endpoint

Area Under Concentration Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-t) of Ribupatide

Time frame:Predose up to 816 hours postdose on Day 35

concentration, descriptive

Primary/protocol endpoint

Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ribupatide

Time frame:Predose up to 816 hours postdose on Day 35

concentration, descriptive

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:Day 1 up to Day 35

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.