A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509704-14-00

Acronym

D7830C00004

Enrollment

Registered

2024-07-02

Start date

2023-04-28

Completion date

2025-09-10

Last updated

2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cirrhotic non-alcoholic steatohepatitis with fibrosis

Brief summary

- The resolution of NASH without any worsening of liver fibrosis (yes/no) after 52 weeks of treatment., - The resolution of NASH is defined as a ballooning score of 0, inflammation score of 0 to 1 and steatosis score of any degree (from 0 to 3), as assessed by NASH CRN/NAS score., - Worsening of fibrosis is defined as an increase in the NASH CRN fibrosis score.

Detailed description

- At least one stage of liver fibrosis improvement with no worsening of NASH(yes/no) after 52 weeks (worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH CRN criteria), - Improvement in fibrosis by at least one stage based on biopsy after Week 52, - ≥ 2-point improvement in NAS after 52 weeks

Interventions

DRUGPlacebo for AZD2693 Solution for Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
- The resolution of NASH without any worsening of liver fibrosis (yes/no) after 52 weeks of treatment., - The resolution of NASH is defined as a ballooning score of 0, inflammation score of 0 to 1 and steatosis score of any degree (from 0 to 3), as assessed by NASH CRN/NAS score., - Worsening of fibrosis is defined as an increase in the NASH CRN fibrosis score.	—

Secondary

Measure	Time frame
- At least one stage of liver fibrosis improvement with no worsening of NASH(yes/no) after 52 weeks (worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH CRN criteria), - Improvement in fibrosis by at least one stage based on biopsy after Week 52, - ≥ 2-point improvement in NAS after 52 weeks	—

Countries

Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026