The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
381
Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg
SC injection of matching placebo
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
Chandler, Arizona, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
Peoria, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
Tucson, Arizona, United States
Del Sol Research Management, LLC ( Site 3211)
Tucson, Arizona, United States
Om Research - Apple Valley ( Site 3244)
Apple Valley, California, United States
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is 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) is a health problem that happens or worsens during a study.
Time frame: Up to 60 weeks
Percentage of Participants Discontinuing Study Medication Due to an AE
An adverse event (AE) is a health problem that happens or worsens during a study.
Time frame: Up to 52 weeks
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52
Participants will be assessed using the NASH CRN scoring system evaluated by BICR for ≥1-stage improvement in fibrosis without worsening of steatohepatitis. Fibrosis is scored from stage 0 to 4 where 0 = None, 1=Perisinusoidal OR periportal, 2=Perisinusoidal AND portal/periportal, 3= Bridging fibrosis, 4=Cirrhosis. No worsening of steatohepatitis is defined as no increase in the ballooning, inflammation, or steatosis scores.
Time frame: Week 52
Change from Baseline in Body Weight At Week 52
Body weight (kg) will be measured using a standardized, digital scale. The percent change from baseline in body weight after 52 weeks will be reported.
Time frame: Week 52
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Om Research LLC ( Site 3245)
Camarillo, California, United States
Velocity Clinical Research, Gardena ( Site 3225)
Gardena, California, United States
Velocity Clinical Research, Huntington Park ( Site 3217)
Huntington Park, California, United States
Velocity Clinical Research, San Diego ( Site 3226)
La Mesa, California, United States
Om Research LLC ( Site 3229)
Lancaster, California, United States
...and 165 more locations