LY3522348, A New Ketohexokinase Inhibitor: A First-in-Human Study in Healthy Adults.

ABSTRACT:

Introduction

This study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of the ketohexokinase inhibitor LY3522348 in healthy participants.

Methods

This first-in-human phase 1 study evaluated LY3522348, a highly selective, oral dual inhibitor of human ketohexokinase (KHK) isoforms C and A. The study was conducted in two parts: a single-ascending dose (SAD) study and a multiple-ascending dose (MAD) study, including a drug-drug interaction analysis with midazolam. Participants in the SAD study received single oral doses of LY3522348 ranging from 5 to 380 mg, while participants in the MAD study received once-daily doses of 50 mg, 120 mg, and 290 mg for 14 days.

Results

A total of 65 healthy participan

SUBMITTER: Fukuda T 

PROVIDER: S-EPMC12182541 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature