NCT06750276

A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Liver Fibrosis
• Hepatic Cirrhosis

Interventions

Type	Name	Description
DRUG	AZD2389	Doses of AZD2389 or placebo will be administered orally.

Timeline

• Start date: 2024-12-06
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2024-12-27
• Last updated: 2025-08-14

Locations

9 sites across 3 countries: United States, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study