NCT07793929 · Kailera
A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide
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 injected under the skin (SC) injection compared with participants with normal renal function.
View original scientific description
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.
Interventions
DRUG
Ribupatide
SC Injection
Primary outcome measures
Maximum Observed Plasma Concentration (Cmax) of Ribupatide
Time frame: 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
Time frame: Predose up to 816 hours postdose on Day 35
Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ribupatide
Time frame: Predose up to 816 hours postdose on Day 35
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Orlando, Florida
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations