Recruiting
Phase 1

Ribupatide

Sponsor:

Kailera

Code:

NCT07793929

Conditions

End Stage Renal Disease

Renal Impairment

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ribupatide

Study Details

Brief summary:

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.

Conditions

End Stage Renal Disease

Renal Impairment

Obesity

Overweight

Study ID

NCT07793929

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Feb 8, 2028

Anticipated

Primary completion date

Feb 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ribupatide

Participants will receive ribupatide once weekly.

Interventions

Ribupatide

SC Injection

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kailera Therapeutics, Inc.

781-317-0291info-clinicalstudies@kailera.com

Locations

Kailera Clinical Site

Recruiting

Orlando, Florida, United States, 32809

Kailera Clinical Site

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Kailera

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Overweight
  • Obesity
  • Ribupatide
  • KAI-9531
  • Glucagon-like Peptide-1
  • GLP-1
  • Glucose-dependent Insulinotropic Peptide
  • GIP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Kailera on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.