Clinical Trials in the USA / NCT07793929
Recruiting
Phase 1
A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide
NCT07793929 · tracked via the Priya Life Science USA tracker
Condition(s) studied
End Stage Renal DiseaseRenal ImpairmentObesityOverweight
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
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.
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
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Kailera Clinical Site | Orlando | Florida | Recruiting |
| Kailera Clinical Site | San Antonio | Texas | Recruiting |
More Kailera trials in the USA
Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
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Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
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Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
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Other trials for the same condition
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
Active, not recruiting
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
Active, not recruiting
Official registry record
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.
View NCT07793929 on ClinicalTrials.gov ↗ ← All trials in the USA