A Phase 1, Single-Dose, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Aleniglipron Pharmacokinetics

Registration

Registration

NCT07872033

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

NOT_YET_RECRUITING

Enrollment

36

Start

2026-10

Primary completion

2027-08

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Conditions

Hepatic Impairment

Interventions

DRUG:Aleniglipron

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• PK parameters including but not limited to AUC0-t [Baseline to Day 5 (Part 1)]
• PK parameters including but not limited to AUC0-inf [Baseline to Day 5 (Part 1)]
• PK parameters including but not limited to Cmax [Baseline to Day 5 (Part 1)]
• PK parameters including but not limited to AUC0-t [Baseline to Day 5 (Part 2)]
• PK parameters including but not limited to AUC0-inf [Baseline to Day 5 (Part 2)]
• PK parameters including but not limited to Cmax [Baseline to Day 5 (Part 2)]