This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and
pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple
ascending doses in participants with Non-alcoholic Steatohepatitis (NASH) with fibrosis Stage
0 to 3 and homozygous for the patatin-like phospholipase domain-containing 3 (PNPLA3) 148M
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 t; t
is estimated to approximately 22 days); however, the length of follow-up may be
shortened or extended if the actual t 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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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