Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
Start Date
5/7/2026
Completion Date
7/7/2027
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
Detailed Description
Study details include: * The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks. * The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks. Disclosure Statement: This is a parallel group treatment study that is blinded to the participants and investigators. Number of Participants: Approximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approximately 52 participants will be randomised to receive AZD2389 and approximately 52 participants will receive placebo. Note: 'Screened' means a participant's, or their legally authorised representative's, agreement to participate in a clinical study following completion of the informed consent process. Study Arms and Duration: Arm A will include 52 participants with SLD and advanced fibrosis who will receive oral AZD2389 for 24 weeks. Arm B will include 52 participants with SLD and advanced fibrosis who will receive oral placebo for 24 weeks.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AZD2389
Placebo
Conditions
Locations
Research Site
Chandler, Arizona 85224
United States
Research Site
Tucson, Arizona 85712
United States
Research Site
Jupiter, Florida 33458
United States
Research Site
Miami, Florida 33122
United States
Research Site
Port Orange, Florida 32127
United States
Research Site
Kansas City, Missouri 64131
United States
Research Site
St Louis, Missouri 63123
United States
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Las Vegas, Nevada 89106
United States
Research Site
Morehead City, North Carolina 28557
United States
Research Site
Raleigh, North Carolina 27607
United States
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Westlake, Ohio 44145
United States
Research Site
Yukon, Oklahoma 73099
United States
Research Site
Clarksville, Tennessee 37040
United States
Research Site
Austin, Texas 78757
United States
Research Site
Denison, Texas 75020
United States
Research Site
Georgetown, Texas 78626
United States
Research Site
Houston, Texas 77004
United States
Research Site
Houston, Texas 77079
United States
Research Site
San Antonio, Texas 78215
United States
Research Site
San Antonio, Texas 78222
United States