EDP-305 in Subjects with Non-Alcoholic Steatohepatitis (NASH)
Research type
Research Study
Full title
A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Non-alcoholic Steatohepatitis (NASH)
IRAS ID
247591
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
Enanta Pharmaceuticals Inc.
Eudract number
2017-004365-27
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This clinical study is trying to see if the investigational product, EDP-305, is safe and to determine the dose that works best to treat a disease known as non-alcoholic steatohepatitis (NASH) with liver scarring.
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 125 patients from approximately 65 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 20 weeks. This will include a Screening Period that will last for up to 28 days, a 12-week Treatment Period, and a 4-week Follow-up Period. During the 12 week treatment period, patients will receive either a daily dose of 1 mg of the study drug, a daily dose of 2.5 mg of the study drug or a daily dose of placebo. Which treatment they receive will depend on the randomisation.
REC name
HSC REC B
REC reference
18/NI/0128
Date of REC Opinion
3 Sep 2018
REC opinion
Further Information Favourable Opinion