256
Participants
Start Date
October 11, 2023
Primary Completion Date
November 30, 2028
Study Completion Date
November 30, 2028
Rosuvastatin
Patients meeting all eligibility criteria will be assigned to a randomization arm prior to initiation of a 4-week lead-in phase of the study. All participants will undergo a 4-week, open-label active run-in phase to evaluate initial safety and adherence to rosuvastatin. During this active run-phase, all participants will receive target dose rosuvastatin-- 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor). After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor) or matching placebo.
RECRUITING
New York Presbyterian/Weill Cornell, New York
RECRUITING
Columbia University Iriving School of Medicine, New York
RECRUITING
Virginia Commonwealth University, Richmond
RECRUITING
Duke Liver Center, Durham
RECRUITING
University of Miami Health System, Miami
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Mayo Clinic, Rochester
RECRUITING
Keck Medical Center of USC, Los Angeles
RECRUITING
LAC + USC Medical Center, Los Angeles
RECRUITING
University of California San Diego NAFLD Research Center, La Jolla
RECRUITING
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco
RECRUITING
UCSF Medical Center, San Francisco
Collaborators (3)
The Cleveland Clinic
OTHER
Columbia University
OTHER
Weill Medical College of Cornell University
OTHER
Duke University
OTHER
Mayo Clinic
OTHER
University of Miami
OTHER
University of Michigan
OTHER
University of California, San Diego
OTHER
University of California, San Francisco
OTHER
LAC+USC Medical Center
OTHER
Virginia Commonwealth University
OTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH