Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07610837
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepatic Cirrhosis
  • Liver Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD2389 — DRUG
    potent, selective, first-in-class, small molecule oral inhibitor of FAP and is being developed for the treatment of CLDs with advanced hepatic fibrosis including cirrhosis.
  • Placebo — OTHER
    Oral administration

Study Details

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.

Key Dates

Start date
May 7, 2026
Status verified
May 2026
Primary completion
Jul 7, 2027
Completion
Jul 7, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Doses of AZD2389 to be administered orally.
  • Placebo Comparator: Arm B
    Doses of placebo to be administered orally.

Primary Outcome Measure

Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24 [ Time Frame: 24 weeks ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85224-
Research SiteJupiterFlorida33458-
Research SiteMiamiFlorida33122-
Research SitePort OrangeFlorida32127-
Research SiteKansas CityMissouri64131-
Research SiteSt LouisMissouri63123-
Research SiteLas VegasNevada89106-
Research SiteMorehead CityNorth Carolina28557-
Research SiteRaleighNorth Carolina27607-
Research SiteWestlakeOhio44145-
Research SiteYukonOklahoma73099-
Research SiteClarksvilleTennessee37040-
Research SiteAustinTexas78757-
Research SiteDenisonTexas75020-
Research SiteGeorgetownTexas78626-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77079-
Research SiteSan AntonioTexas78215-
Research SiteSan AntonioTexas78222-

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