A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Phase 2

Active, not recruiting

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Drug: AZD2693; Other: Placebo

• Registration Number: NCT05809934
• Lead Sponsor: AstraZeneca

Brief Summary

A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-23
• Study Start: 2023-03-15
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-07-09
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2693 dose 1	AZD2693	Participants will receive AZD2693 dose 1
Placebo	Placebo	Participants in this arm will receive placebo
AZD2693 dose 2	AZD2693	Participants will receive AZD2693 dose 2

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment	after 52 weeks	To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment	after 52 weeks	To assess the effects of AZD2693 versus placebo on histological fibrosis improvement
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment	after 52 weeks	To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment	after 52 weeks	To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam