NCT07793929

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
16mo left

Started Sep 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Feb 2028

First Submitted

Initial submission to the registry

August 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 8, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.4 years

First QC Date

August 25, 2026

Last Update Submit

September 30, 2026

Conditions

End Stage Renal DiseaseRenal ImpairmentObesityOverweight

Keywords

OverweightObesityRibupatideKAI-9531Glucagon-like Peptide-1GLP-1Glucose-dependent Insulinotropic PeptideGIP

Outcome Measures

Primary Outcomes (3)

  • Maximum Observed Plasma Concentration (Cmax) of Ribupatide

    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

    Predose up to 816 hours postdose on Day 35

  • Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ribupatide

    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)

    Day 1 up to Day 35

Study Arms (1)

Ribupatide

EXPERIMENTAL

Participants will receive ribupatide once weekly.

Drug: Ribupatide

Interventions

RibupatideDRUG

SC Injection

Also known as: KAI-9531
Ribupatide

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kailera Clinical Site

Orlando, Florida, 32809, United States

RECRUITING

Kailera Clinical Site

San Antonio, Texas, 78215, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicRenal InsufficiencyObesityOverweight

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Central Study Contacts

Kailera Therapeutics, Inc.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 31, 2026

Study Start

September 8, 2026

Primary Completion (Estimated)

February 8, 2028

Study Completion (Estimated)

February 8, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

US(2)