A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of cotadutide at 300 and 600 μg in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis.
Inclusion Criteria:
Provision of informed consent
Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.
Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria:
Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.
Exclusion Criteria:
CABA, C1056ABJ, Argentina
Kawasaki-shi, 215-0026, Japan
Kawasaki-shi, 216-8511, Japan
Kure-shi, 737-0023, Japan
Shinjuku-ku, 160-0023, Japan
Suita-shi, 564-0013, Japan
Takasaki-shi, 370-0829, Japan
Toon-shi, 791-0281, Japan
Gangwon-do, 26426, South Korea