Study identifier:D7830C00004
ClinicalTrials.gov identifier:NCT05809934
EudraCT identifier:2022-001629-65
CTIS identifier:2023-509704-14-00
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
Nonalcoholic Steatohepatitis
Phase 2
No
AZD2693
All
220
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
AstraZeneca K.K
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
Location
Location
Konstanz, Germany, 78464
Location
Jung-gu, Republic of Korea, 41944
Location
Seoul, Republic of Korea, 03080
Location
Kuala Lumpur, Malaysia, 59100
Location
Pulau Pinang, Malaysia, 10450
Location
Eskisehir, Turkey, 26480
Location
Rize, Turkey, 530020
Location
Bursa, Turkey, 16059
Arms | Assigned Interventions |
---|---|
Experimental: AZD2693 dose 1 Participants will receive AZD2693 dose 1 | Drug: AZD2693 AZD2693 solution SC once per month |
Experimental: AZD2693 dose 2 Participants will receive AZD2693 dose 2 | Drug: AZD2693 AZD2693 solution SC once per month |
Placebo Comparator: Placebo Participants in this arm will receive placebo | Other: Placebo Sodium chloride 0.9% solution SC once per month |
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