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

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis (NASH)

In brief

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 who are carriers of the patatin-like phospholipase domain-containing 3 (PNPLA3) 148M risk alleles.

Key facts

Study ID: NCT04483947
Run by: AstraZeneca
People needed: 74
Starts: 2020-11-06
Expected to finish: 2023-12-18
Last updated by the study team: 2024-01-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For Cohorts 1 to 3:
An MRI-PDFF ≥7% and one of the following:
Previous liver biopsy: Acceptable if taken in the previous 3 years for fibrosis stages F0 to F2, or within the previous 1 year for stage F3; or
Previous imaging results taken in the previous 2 years: An MRE between 2.55 kPa and 3.63 kPa, or a vibration-controlled transient elastography (VCTE) between 7.1 kPa and 11.9 kPa;
Participants who are homozygous for rs738409 (PNPLA3 148M). Cohort 2 will enroll participants who are heterozygous for PNPLA3 148M.
For Cohort 4:
An MRI-PDFF ≥ 7% and participant's consent for a liver biopsy.
Participants with suspected or confirmed Non-alcoholic fatty liver disease (NAFLD) or NASH are eligible for the Screening liver biopsy if they meet main protocol inclusion/exclusion criteria AND have any of the following:
Alanine aminotransferase > Upper Limit of Normal (ULN) but < 3 × ULN, OR Imaging demonstrating hepatic steatosis including attenuation parameter (CAP) > 290dB/m, OR A Magnetic resonance elastography (MRE) between 2.55 kPa and 3.63 kPa, or a vibration-controlled transient elastography (VCTE) between 7.1 kPa and 11.9 kPa.
Histologic evidence of NAFLD or NASH with a NASH Activity Score (NAS) ≥ 3 (independent of subcategory scoring) following Screening liver biopsy.
Participants who are homozygous for rs738409 (PNPLA3 148M).

You may not qualify if…

History of liver transplant, or current placement on a liver transplant list (this may be checked at the optional Pre-Screening Visit).
History or presence of hepatic disease (with the exception of hepatic steatosis, NASH) or evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, primary biliary cirrhosis, primary sclerotic cirrhosis, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (this may be checked at the optional Pre-Screening Visit).
Histological or imaging (MRE or VCTE) evidence of cirrhosis.
Participants with history or pre-existing renal disease, as defined below:
estimated glomerular filtration rate < 60 mL/min/1.73 m\^2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula)
Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds).
History of major bleed or high-risk of bleeding diathesis.

Where it is running

Research Site — Chula Vista, California, United States
Research Site — La Mesa, California, United States
Research Site — Montclair, California, United States
Research Site — San Diego, California, United States
Research Site — Doral, Florida, United States
Research Site — Hialeah, Florida, United States
Research Site — Hialeah, Florida, United States
Research Site — Miami Lakes, Florida, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Morehead City, North Carolina, United States
Research Site — Columbus, Ohio, United States
Research Site — Hershey, Pennsylvania, United States
Research Site — Arlington, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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