Ribupatide PK in People with Kidney Impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, interventional trial compares the pharmacokinetics of ribupatide after a single subcutaneous dose in participants with end-stage renal disease or severe renal impairment versus participants with normal renal function. The study aims to estimate key PK parameters to understand dosing considerations in kidney impairment. Eligible participants include adults with BMI 18.5 or higher, and women must meet pregnancy restrictions and testing requirements. Exclusion criteria cover recent illnesses and various health conditions to minimize confounding factors. The trial is conducted at Kailera Clinical Sites in Orlando and San Antonio and is sponsored by Kailera.

Why it matters

Who can join: the full rules

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 it's running

• Kailera Clinical Site
  Orlando, Florida, United States Recruiting
• Kailera Clinical Site
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Kailera Therapeutics, Inc.
• Email: info-clinicalstudies@kailera.com
• Phone: 781-317-0291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.