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

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.

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.