Study for Tropifexor (LJN452) and Licogliflozin (LIK066) on NASH
Research type
Research Study
Full title
A randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy, compared to each monotherapy, for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE)
IRAS ID
269472
Contact name
Ashis Mukhopadhya
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-002324-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
The disease area for this study is NASH (Non-Alcoholic Steatohepatitis) or also known as Non-alcoholic fatty liver disease (NAFLD).
There will be two medicines, in different combinations, tested in this study: Tropifexor (140µg and 30mg) and Licogliflozin (30mg) once a day. This study will have a screening period of 8 weeks, a treatment period of 48 weeks and a 4 week follow up period, throughout the trial additional safety tests will be performed. The standard tests performed by the NHS will be used check the liver will be used in this study (Ultrasound, Biopsy of the liver and Fibroscan), there will be additional tests performed to help check the safety of patients.
Both Tropifexor (LJN452) and Licogliflozin (LIK066) work on the Liver in different ways. They are used to help reduce bile in the liver, this would then make your Liver better and reduce the fat build up in the liver. This then helps to reduce the amount of damage the liver has over the coming years. There will be 3 sites being used to try to identify 6 patients that this study will be suitable.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1875
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion