Norursodeoxycholic acid vs. placebo in NASH
Research type
Research Study
Full title
Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)
IRAS ID
262054
Contact name
Michael Stieß
Contact email
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2018-003443-31
Duration of Study in the UK
3 years, 2 months, 16 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) is a very common cause of chronic liver disease in industrialised countries. NAFLD comprises a disease spectrum ranging from simple fatty liver to non-alcoholic steatohepatitis (NASH), liver cirrhosis and liver cancer.
So far, no drug has been approved for the treatment of NAFLD or NASH. Dietary changes and lifestyle modifications are the only available and recommended options for therapeutic management of this disease.The present trial is expected to provide efficacy and safety data for long-term treatment over 72 weeks with 1000 mg or 1500 mg of norursodeoxycholic acid (norUDCA) versus placebo in patients with NASH.
To confirm the diagnosis, a liver biopsy must be done at the start of the study if there is no historical biopsy of less than 3 months. Once the diagnosis is confirmed and the other eligibility criteria are met, participants will be assigned to one of 3 treatment groups (1000 mg norUDCA, 1500 mg norUDCA or placebo). The study drug is to be taken orally, once daily with fluid. The assignment to the treatment group is done independently and can’t be influenced by the people involved in the study. Neither the participant, nor the investigator will know which study drug a participant is taking.
The maximum duration of the study is 19 to 20 months for each participant, with 10 visits at the research site. Apart from liver biopsies at screening and end of study, diagnostic procedures and examinations exercised in this clinical trial are mostly routine or non-invasive procedures.
The study will be conducted in 13 European countries. 90 hepatologists/gastroenterologists will participate with the aim to enroll 360 participants.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0105
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion