EDP-305 in Subjects with Liver-Biopsy Proven NASH (ARGON-2) V1.0
Research type
Research Study
Full title
A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects with Liver-Biopsy Proven Non-Alcoholic Steatohepatitis (NASH) (ARGON-2)
IRAS ID
277780
Contact name
Kaushik Kosh Agarwal
Contact email
Sponsor organisation
Enanta Pharmaceuticals Inc.
Eudract number
2019-003876-38
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Summary of Research
This clinical study is trying to compare the investigational product, EDP-305, with placebo to see which treatment is better or is safer than having no treatment for a disease known as non-alcoholic steatohepatitis (NASH).NASH is a type of fatty liver disease where fat builds up in the liver and causes inflammation and scarring and is unrelated to consumption of alcohol. NASH is considered a serious disease for which there is currently no satisfactory method of diagnosis, prevention or treatment authorised.
If NASH is not treated, it can progress to life-threatening conditions such as scarring of the liver (cirrhosis) and liver cancer.
The study will involve approximately 336 patients from approximately 112 research sites globally. Within the UK, the study will be conducted within secondary care facilities.
Patients aged between 18 – 75 years old with a presence of NASH will be invited to take part.
The patients will be in the study for up to 84 weeks. This will include a Screening Period that will last for up to 56 days, a 72-week Treatment Period, and a 4-week Follow-up Period. During the 72 week treatment period, patients will receive either a daily dose of 1.5 mg of the study drug, a daily dose of 2.0 mg of the study drug or a daily dose of placebo. Which treatment they receive will depend on the randomisation.
Summary of Results
No Lay Summary has been provided by the Sponsor for this study.REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0469
Date of REC Opinion
17 Jun 2020
REC opinion
Further Information Favourable Opinion