Phase 2b Study of MK-3655 in Individuals with Pre-cirrhotic NASH
Research type
Research Study
Full title
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
IRAS ID
1005282
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2019-003048-63
Clinicaltrials.gov Identifier
Research summary
Nonalcoholic fatty liver disease (NAFLD) is a condition where excess fat builds up in the liver. NAFLD encompasses a spectrum of disease, including Nonalcoholic Steatohepatitis (NASH). Globally, 25% of the adult population is estimated to have NAFLD. Lifestyle changes such as weight loss and exercise remain the most recommended treatment; however, only a minority of patients achieve and sustain weight loss. Currently, there are no approved drugs for the treatment of NASH demonstrating a significant unmet medical need.
This trial is testing MK-3655 compared to placebo in people with pre-cirrhotic NASH. MK-3655 is an experimental drug that has not been approved for sale.
About 328 male and female participants, aged 18-80 years old, will take part in this trial.
The duration of the trial will be approximately 64 weeks and for participants who are able to have a baby approximately 72 weeks.
There is a screening phase, lasting about 6 weeks, to see if patients can join the trial.
Eligible participants are then put in 1 of 4 treatment groups: MK-3655 (Group 1: 50mg, Group 2: 100 mg and Group 3: 300mg) or placebo (Group 4).
The treatment period will last 54 weeks with the participant visiting the site 12 times. The trial doctor/site staff will contact via telephone between site visits. Participants will administer MK-3655 or placebo as 2 injections every 4 weeks. There will be a period of time when all participants will get only placebo.
After the treatment period, participants will enter the post-treatment follow up period and will complete a site visit four weeks later. Additional follow-up telephone contact (2 times over 8 weeks) will be completed to assess pregnancy status.
The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0433
Date of REC Opinion
18 Jul 2022
REC opinion
Further Information Favourable Opinion