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MK-3655 for Non-alcoholic Fatty Liver Disease
Study Summary
This trial will study whether MK-3655 can help resolve nonalcoholic steatohepatitis (NASH) without worsening liver fibrosis.
- Non-alcoholic Fatty Liver Disease (NAFLD)
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What is the official regulatory stance on MK-3655?
"While there is some data supporting MK-3655's safety, it is still in Phase 2 of clinical trials and has not yet been proven effective. Therefore, it received a score of 2."
Are there any open enrolment positions for this clinical trial?
"That is correct, the trial is currently ongoing and looking for 328 participants from 49 different sites. The listing was first posted on November 11th 2020 and last updated on November 3rd 2022."
What are the investigators of this trial hoping to achieve?
"The primary outcome of this study is to evaluate the percentage of participants who discontinue study medication due to an adverse event. The secondary outcomes include the percentage of participants with at least a 1-stage improvement in fibrosis without worsening of steatohepatitis, as assessed by the NASH Clinical Research Network scoring system, and the percentage of participants with at least a 2-point improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) without worsening of fibrosis."
Are there a number of research hospitals conducting this clinical trial in Canada?
"This clinical study is enrolling patients from 54 different locations, three of which are: Impact Research Institute in Waco, Texas; Texas Clinical Research Institute in Arlington, Florida; and Covenant Metabolic Specialists, LLC in Fort Myers, Arkansas."
How many individuals are being sought for this clinical trial?
"In order to move forward with the study, 328 patients that meet specific clinical criteria are needed. The sponsor, Merck Sharp & Dohme Corp., will be running the trial from various locations including Impact Research Institute ( Site 2685) in Waco, Texas and Texas Clinical Research Institute ( Site 2619) in Arlington, Florida."
For this particular experiment, are adults in their 80s being recruited?
"According to the eligibility guidelines, patients must be between 18-80 years old to take part in this particular trial. However, there are 24 other clinical trials available for minors and 203 studies open to adults over 65."
How can I sign up for this clinical trial?
"This study needs 328 individuals aged 18-80 who have nonalcoholic steatohepatitis. Other inclusion criteria are as follows: no history of Type 2 diabetes mellitus (T2DM) OR controlled T2DM via diet or stable antihyperglycemic agent doses, male participants must use contraception consistently with local regulations, female participants cannot be pregnant/breastfeeding and must either not be a woman of child-bearing potential (WOCBP) OR a WOCBP using contraception that is highly effective during the intervention period + for 16 weeks post-last dose of study intervention, BMI ≥25 kg/m^2 and"
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