A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients

Summary

Participation Requirements

Description

This study is a double blind, randomised, placebo-controlled, multi-centre study in participants with NASH and fibrosis stage between F0 (no fibrosis) and F3 (bridging fibrosis), and who are homozygous for the PNPLA3 148M risk allele. The study will comprise of: An optional Pre Screening Visit may b...

This study is a double blind, randomised, placebo-controlled, multi-centre study in participants with NASH and fibrosis stage between F0 (no fibrosis) and F3 (bridging fibrosis), and who are homozygous for the PNPLA3 148M risk allele. The study will comprise of: An optional Pre Screening Visit may be completed to determine PNPLA3 genotype and collect minimal baseline data and only participants homozygous for rs738409 will continue the study and enter the Screening Period. The Pre-Screening Visit is optional and sites may proceed with full screening if this is preferred. A Screening Period with a maximum of 60 days. An 8-week dosing period during which participants will be resident of the study site for Dose 1 and Dose 3. Dose 1 will have participants reside at the study site from the day prior to study intervention administration (Day -1) until at least 2 days after study intervention administration with discharge on Day 3. Dose 2 will be administered at the study site on Day 29 with no overnight stay. Dose 3 will have participants reside at the study site from the day prior to study intervention administration (Day 56) until at least 2 days after study intervention administration with discharge on Day 59. All study interventions and PD assessments will be administered after a 10 hour fast. Each participant will be followed for 15 weeks post last dose (approximately 5× t½; t½ is estimated to approximately 22 days); however, the length of follow-up may be shortened or extended if the actual t½ is considerably shorter or longer than predicted. The study will be performed at up to 30 study sites in the United States (US) and up to 5 study sites in Mexico. Approximately 60 participants comprised of male participants and female participants of non-childbearing potential will be randomized into the first 3 cohorts of this study in order to achieve 48 evaluable participants.

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