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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Kailera
Study ID
NCT07793929
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Ribupatide — DRUG
    SC Injection

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 8, 2026
Status verified
Sep 2026
Primary completion
Feb 8, 2028
Completion
Feb 8, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ribupatide
    Participants will receive ribupatide once weekly.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Ribupatide [ Time Frame: Predose up to 816 hours postdose on Day 35 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kailera Clinical SiteSan AntonioTexas78215-

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