Study identifier:D7930C00002
ClinicalTrials.gov identifier:NCT06750276
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2a, Randomised, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Explore the Pharmacodynamic Effects of AZD2389 in Participants with Liver Fibrosis and Compensated Cirrhosis
Liver Fibrosis
Phase 2
No
AZD2389
All
36
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
-
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis. The study will also examine how the drug acts on the body
Study details include: The study duration will be up to 63 days (9 weeks). • 1 or 2 screening visits (up to 28 days before treatment) • 28 days of treatment including 5 clinic visits • Week 1: 24-hour in-clinic stay (Day 1) • Week 2: Outpatient clinic visit (Day 7) • Week 3: Outpatient clinic visit (Day 14) • Week 4: Telephone visit (Day 21) • Week 5: 24 to 48-hour in-clinic stay (Day 28) • Week 6: Follow-up visit (Day 35) Disclosure Statement: The study consists of two cohorts, each with a parallel-group design and two arms, with participants blinded to treatment allocation. Number of Participants: The study will randomise approximately 36 participants in total. Cohort A: Approximately 75 participants with presumed MASH/NASH with fibrosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo. Cohort B: Approximately 75 participants with SLD with advanced fibrosis including compensated cirrhosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo
Location
Status
Location
San Antonio, TX, United States, 78215
Status
Recruiting
Location
Morehead City, NC, United States, 28557
Status
Recruiting
Location
San Juan, PR, United States, 00927
Status
Recruiting
Location
San Antonio, TX, United States, 78229
Status
Recruiting
Location
Chandler, AZ, United States, 85224
Status
Recruiting
Location
Atlanta, GA, United States, 30349
Status
Recruiting
Location
Houston, TX, United States, 77079
Status
Recruiting
Location
Rialto, CA, United States, 92377
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Other: Cohort A Participants with presumed MASH/NASH with fibrosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo. | Drug: AZD2389 Doses of AZD2389 or placebo will be administered orally. |
Other: Cohort B Participants with SLD with advanced fibrosis including compensated cirrhosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo. | Drug: AZD2389 Doses of AZD2389 or placebo will be administered orally. |
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