Clinical Trial Details

Trial ID: L0196
Source ID: NCT04971785
Associated Drug: Semaglutide
Title: Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Participants With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic Steatohepatitis
Interventions: Drug: Semaglutide (SEMA)|Drug: Cilofexor (CILO)/Firsocostat (FIR)|Drug: PTM SEMA|Drug: PTM CILO/FIR
Outcome Measures: Percentage of Participants Who Achieve ??? 1-Stage Improvement in Fibrosis According to the NASH Clinical Research Network (CRN) Classification Without Worsening of NASH in Participants Treated With SEMA + CILO/FIR Versus Placebo|Percentage of Participants With NASH Resolution in Participants Treated with SEMA+CILO/FIR Versus Placebo|Percentage of Participants With NASH Resolution In Participants Treated With SEMA+CILO/FIR Versus CILO/FIR Alone|Percentage of Participants Who Achieve ???1-Stage Improvement in Fibrosis (According to the NASH CRN Classification) Without Worsening of NASH in Participants Treated With SEMA+CILO/FIR Versus SEMA Alone
Sponsor/Collaborators: Gilead Sciences|Novo Nordisk A/S
Gender: All
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 440
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: August 9, 2021
Completion Date: March 2024
Results First Posted: --
Last Update Posted: March 11, 2022
Locations: Digestive Health Specialists, Dothan, Alabama, United States|North Alabama Health Research, LLC, Madison, Alabama, United States|The Institution For Liver Health dba Arizona Liver Health, Chandler, Arizona, United States|The Institute for Liver Health DBA Arizona Liver Health, Peoria, Arizona, United States|The Institution For Liver Health dba Arizona Liver Health, Tucson, Arizona, United States|Arkansas Diagnostic Center, Little Rock, Arkansas, United States|ARCare Center for Clinical Research, Little Rock, Arkansas, United States|Southern California Research Center, Coronado, California, United States|Digestive Health Research of Southern California, Long Beach, California, United States|United Medical Doctors, Murrieta, California, United States|California Liver Research Institute, Pasadena, California, United States|2006 North Riverside Avenue, Suite A, Rialto, CA, 92377, US, Rialto, California, United States|Research and Education Inc., San Diego, California, United States|TriWest Research Associates, LLC, San Diego, California, United States|Precision Research Institute, San Diego, California, United States|Medical Associates Research Group, San Diego, California, United States|Quest Clinical Research, San Francisco, California, United States|South Denver Gastroenterology, Englewood, Colorado, United States|Indago Research and Health Center, Inc., Hialeah, Florida, United States|Nature Coast Clinical Research, Inverness, Florida, United States|Schiff Center for Liver Diseases/ University of Miami, Miami, Florida, United States|Advanced Pharma CR, LLC, Miami, Florida, United States|Advanced Research Institute, Inc., New Port Richey, Florida, United States|Ocala GI Research, Ocala, Florida, United States|International Medical Investigational Centers, Inc., Palmetto Bay, Florida, United States|Advanced Medical Research Center, Port Orange, Florida, United States|Florida Medical Clinic, LLC, Zephyrhills, Florida, United States|Gastrointestinal (GI) Specialists of Georgia, Marietta, Georgia, United States|Indiana University Health Enterprise Clinical Research Operations, Indianapolis, Indiana, United States|Digestive Research Alliance of Michigan, South Bend, Indiana, United States|Kansas Medical Clinic PA, Topeka, Kansas, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Louisiana Research Center, LLC, Shreveport, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Greater Boston Gastroenterology, Framingham, Massachusetts, United States|Hawthorn Medical Associates, South Dartmouth, Massachusetts, United States|Southern Therapy and Advanced Research, Jackson, Mississippi, United States|Clinical Research Professionals, Chesterfield, Missouri, United States|Sierra Clinical Research, Las Vegas, Nevada, United States|Digestive Disease Research, Florham Park, New Jersey, United States|Northwell Health Center for Liver Diseases, Manhasset, New York, United States|Asheville Gastroenterology, a Division of Digestive Health Partners, PA, Asheville, North Carolina, United States|Northeast GI Research Division, Concord, North Carolina, United States|Lucas Research, Inc., Morehead City, North Carolina, United States|DSI Research, Springboro, Ohio, United States|Clinical Research Institute of Ohio, LLC, Westlake, Ohio, United States|Options Health Research, LLC, Tulsa, Oklahoma, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States|Velocity Clinical Research - Providence, East Greenwich, Rhode Island, United States|University Gastroenterology, Providence, Rhode Island, United States|Digestive Disease Research Center, Greenwood, South Carolina, United States|Quality Medical Research, PLLC, 330 Wallace Road Suite 103, Nashville, TN, 37211, US, Nashville, Tennessee, United States|Texas Clinical Research Institute, Arlington, Texas, United States|Internal Medicine Digestive and Liver Diseases Clinical Trials, Dallas, Texas, United States|South Texas Research Institute, Edinburg, Texas, United States|American Research Corporation at the Texas Liver Institute, San Antonio, Texas, United States|Diabetes and Glandular Disease Clinic, P.A., San Antonio, Texas, United States|Digestive Health Research of North Texas, Wichita Falls, Texas, United States|University of Virginia Medical Center, Charlottesville, Virginia, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Liver Institute Northwest, Seattle, Washington, United States|Toronto General Hospital - University Health Network, Toronto, Canada|Toronto Liver Centre, Toronto, Canada|(G.I.R.I.) Gastrointestinal Research Institute, Vancouver, Canada|Fukui-ken Saiseikai Hospital, Fukui, Japan|Juntendo University Shizouka Hospital, Izunokuni, Japan|University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan|Japanese Red Cross Masashino Hospital, Musashino-city, Japan|Osaka City University Hospital, Osaka, Japan|Saga University Hospital, Saga-shi, Japan|Sapporo-Kosei General Hospital, Sapporo-shi, Japan|Saiseikai Suita Hospital, Suita, Japan|Ehime University Hospital, Toon-Shi, Japan|Yamagata University Hospital, Yamagata, Japan|Yokohama City University Hospital, Yokohama-shi, Japan|FDI Clinical Research, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT04971785

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D327 Semaglutide Chemical drug DB13928 GLP1R agonist Antidiabetic drug Under clinical trials Details
D078 Cilofexor Chemical drug DB15168 FXR agonist Enhance lipid metabolism Under clinical trials Details
D083 CLA Chemical drug DB01211 KCNH2; SLCO1B1; SLCO1B3 -- Under clinical trials Details
D136 Firsocostat Chemical drug DB16166 ACC inhibitor Enhance lipid metabolism Under clinical trials Details