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NCT Number: NCT07793929

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ribupatide

Drug

SC Injection

Other names: KAI-9531

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Ribupatide

    Time frame: Predose up to 816 hours postdose on Day 35

  2. 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

  3. 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

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 35

Study contacts

Contact information is provided by the study sponsor or research team.

Kailera Therapeutics, Inc.

CONTACT

[email protected]

781-317-0291

Sponsors and collaborators

Lead sponsor

Kailera

Industry

Registry information

Official study title

A Phase 1, Open Label, Parallel Group Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics of Ribupatide in Healthy Participants and in Participants Living With Severe Renal Impairment or End Stage Kidney Disease

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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