CWoW - A Phase 3 Double Blind, Randomized Placebo Study of MGL‐3196
Research type
Research Study
Full title
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
IRAS ID
264974
Contact name
Quentin Anstee
Contact email
Sponsor organisation
Madrigal Pharmaceuticals, Inc.
Eudract number
2018-004012-22
Clinicaltrials.gov Identifier
122865, US IND
Duration of Study in the UK
7 years, 1 months, days
Research summary
Non‐Alcoholic Steatohepatitis (NASH) is a liver disease that is associated with an increased amount of fat and inflammation in the liver. NASH increases the chances of getting heart disease and may in time lead to fibrosis of the liver. When enough scarring happens the liver can become cirrhotic and lead to serious complications. NASH fibrosiscan only be accurately diagnosed by taking a sample of tissue called a “biopsy” directly from the liver. There are currently no approved medicines for NASH.
Madrigal Pharmaceuticals, Inc. is running this study to see if a medicine named MGL‐3196 (resmetirom), will help in the treatment of patients with NASH and fibrosis to resolve NASH and also to find out how safe it is to use in people with NASH. MGL‐3196 was previously tested in a 9‐month study in patients with NASH and was found to be safe and well‐tolerated, caused a decrease in the amount of fat in the liver, and caused a decrease in NASH resolution compared with placebo patients.
MGL‐3196 works with a form of thyroid hormone receptor in the liver to decrease the amount of fat that has built up in the liver and possibly reduce the inflammation associated with NASH. MGL‐3196 is an investigational medication meaning that it has not been approved by regulatory authorities for use in the treatment of NASH.
Approximately 2000 participants at about 150 clinical study sites in North America, Europe and Australia will take part in the study. Participants will undergo various study procedures including liver biopsies, blood and urine tests. The study duration will be up to approximately 57 months (4 3/4 years) for each participant (including 8 weeks screening period and up to 54 months of treatment), and during this time they will be required to visit the clinic at most 30 times.REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0342
Date of REC Opinion
25 Jul 2019
REC opinion
Further Information Favourable Opinion