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

Registration

Registration

NCT07793929

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

RECRUITING

Enrollment

32

Start

2026-09-08

Primary completion

2028-02-08

Lead sponsor

Kailera

Conditions

End Stage Renal Disease; Renal Impairment; Obesity; Overweight

Interventions

DRUG:Ribupatide

Results posted

FALSE

Registered primary outcomes

• 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]