The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly
Tablets administered orally once daily
Tablets administered orally once daily
Institute for Liver Health - Arizona Liver Health
Chandler, Arizona, United States
Southern California Research Centers
Coronado, California, United States
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: First dose date up to Week 24 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0.
Time frame: First dose date up to 24 weeks plus 30 days
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University of California San Diego (UCSD)
La Jolla, California, United States
Ruane Clinical Research Group, Inc
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Medical Associates Research Group
San Diego, California, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
...and 8 more locations