This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
183
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) was used to assess treatment response. The NASH CRN scoring scales were: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution was defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
Time frame: Week 52
Percentage of Participants Who Experienced an Adverse Event (AE)
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time frame: Up to 64 weeks
Percentage of Participants Discontinuing Study Medication Due to an AE
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time frame: Up to 52 weeks
Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks
LFC % was measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) and evaluated by BICR. MRI-PDFF is a highly accurate noninvasive measure of the proportion of fat content of a tissue.
Time frame: Baseline and Week 24
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks
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Adobe Clinical Research, LLC ( Site 2644)
Tucson, Arizona, United States
Arizona Liver Health ( Site 9026)
Tucson, Arizona, United States
Del Sol Research Management ( Site 2674)
Tucson, Arizona, United States
Arkansas Gastroenterology - North Little Rock ( Site 9015)
North Little Rock, Arkansas, United States
Hope Clinical Research, Inc. ( Site 2601)
Canoga Park, California, United States
Velocity Clinical Research, Huntington Park ( Site 9022)
Huntington Park, California, United States
UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si
La Jolla, California, United States
Ruane Clinical Research Group, Inc ( Site 9014)
Los Angeles, California, United States
Velocity Clinical Research, Westlake ( Site 9013)
Los Angeles, California, United States
Catalina Research Institute, LLC ( Site 2643)
Montclair, California, United States
...and 170 more locations
Participants were evaluated with the NASH CRN scoring system with BICR with ≥1 stage improvement in fibrosis without worsening of steatohepatitis defined as no increase in the ballooning, inflammation, or steatosis scores.
Time frame: Week 52
Percentage of Participants With ≥2 Point Improvement in NAS With ≥1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks
Participants with ≥2 point improvement in the NAS with ≥1 point improvement in inflammation or ballooning without worsening of fibrosis were assessed with the NASH CRN scoring system (evaluated by BICR). The NAS was calculated as the unweighted sum of the scores and ranges from 0-8 (highest activity).
Time frame: Week 52