NCT05809934

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	AZD2693	AZD2693 solution SC once per month
OTHER	Placebo	Sodium chloride 0.9% solution SC once per month

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-07-14
• Completion: 2025-09-29
• First posted: 2023-04-12
• Last updated: 2025-10-28

Locations

164 sites across 22 countries: United States, Argentina, Brazil, Chile, China, Colombia, Germany, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study