Clinical trial

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

Opening soon · Phase 1 · 1 countries · Registry ID NCT07793929

Opening soonPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 85 Years
SexAll
Healthy volunteersAccepted
ConditionEnd Stage Renal Disease, Renal Impairment, Obesity, Overweight

Full registry criteria

Inclusion Criteria: * Have body mass index ≥18.5 at Screening. * Female Participants: Must not be 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. * Have suitable venous access for blood sampling. Exclusion Criteria: * Have 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. * Have abnormal thyroid-stimulating hormone at Screening. * Have any history of malignant disease including in situ cervical or prostate cancer within the last 5 years. * Have history of or positive test results at the Screening Visit for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) confirmation if positive. * Have 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. * Have 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. * Have known hypersensitivity to the study drug, glucagon-like peptide-1 (GLP-1) therapies, or any of the study drug ingredients. * Have had any vaccinations within 30 days prior to Screening. * Have current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days prior to the dose of study drug.

Treatments and study arms

Ribupatide

Drug

SC Injection

Primary outcomes

Maximum Observed Plasma Concentration (Cmax) of RibupatidePredose up to 816 hours postdose on Day 35
Area Under Concentration Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-t) of RibupatidePredose up to 816 hours postdose on Day 35
Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of RibupatidePredose up to 816 hours postdose on Day 35

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Kailera Clinical Site🇺🇸 San Antonio, Texas, United States