A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide
Kailera · NCT07793929
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–85 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 32
- US sites recruiting
- 2
- Study start
- September 8, 2026
- Record last updated
- October 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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 subcutaneous (SC) injection compared with participants with normal renal function.
Being studied: Ribupatide
Conditions: End Stage Renal Disease; Renal Impairment; Obesity; Overweight
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Kailera Clinical Site
Orlando, FL 32809
Kailera Clinical Site
San Antonio, TX 78215
Study contacts (from the official record)
- Kailera Therapeutics, Inc. · 781-317-0291 · info-clinicalstudies@kailera.com
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