End Stage Renal DiseaseRenal ImpairmentObesityOverweight
Investigational drug(s) / intervention(s)
Ribupatide
Ribupatide: SC Injection
Study 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
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Maximum Observed Plasma Concentration (Cmax) of Ribupatide — Predose 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 Ribupatide — Predose up to 816 hours postdose on Day 35
Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ribupatide — Predose up to 816 hours postdose on Day 35
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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