A Phase 1, Double Blind, Randomized, Placebo-Controlled, Multi-Center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2693 in Patients with Non-Alcoholic Steatohepatitis (NASH) with Fibrosis Stage 0-3 and Carriers of the PNPLA3 148M Risk Allele
The purpose of this voluntary research study is to test the safety and ability to tolerate of the an injection treatment of the study drug AZD2693 in patients with Non-alcoholic Steatohepatitis (NASH).
If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, height, and weight measurements, an electrocardiogram, questionnaires, COVID-19 screening and test, an MRI, a liver biopsy, an elastography, telemetry, blood draws, urine drug testing and a pregnancy test if applicable. For treatment, you will be asked to administer study drug or placebo (a substance that has no therapeutic effect) at week 1, week 5 and week 9. There will be 13 other study visits that will occur biweekly.
pre-existing renal disease