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NCT07793929PHASE1RecruitingAccepts Healthy Volunteers

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

Kailera

Start Date

9/8/2026

Completion Date

2/8/2028

Summary

The primary objective of the study is to estimate the PK parameters of ribupatide in participants with severe renal impairment or end-stage kidney disease (ESKD) after a single dose of ribupatide subcutaneous (SC) injection compared with participants with normal renal function.

Eligibility Criteria

Age Range: 18 years to 85 years

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.

Interventions

DRUG

Ribupatide

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Conditions

End Stage Renal DiseaseRenal ImpairmentObesityOverweight

Locations

Kailera Clinical Site

Orlando, Florida 32809

United States

Kailera Clinical Site

San Antonio, Texas 78215

United States