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HomeTrials › NCT07793929

Obesity & weight · Phase 1 · Opening soon

A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide

NCT07793929 · Sponsor: Kailera

What this trial means for you

This study is opening soon at 1 US site. It's studying Ribupatide for end stage renal disease, renal impairment, obesity.

Who can joinAll sexes, 18 Years – 85 Years
Healthy volunteersAccepted
What you'd takeRibupatide
Study length~17 months overall
Planned participants32
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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.

Study sites by state

Texas

  • Kailera Clinical Site, San Antonio

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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