Clinical Trial Details

Trial ID: L0187
Source ID: NCT03987451
Associated Drug: Semaglutide
Title: A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
Acronym: --
Status: Completed
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Steatohepatitis
Interventions: Drug: Semaglutide|Drug: Placebo (semaglutide)
Outcome Measures: At least 1 stage of liver fibrosis improvement with no worsening of NASH after 48 weeks (yes/no) (worsening defined as an increase of at least one stage of either lobular inflammation, hepatocyte ballooning or steatosis according to NASH CRN criteria)|Relative change in liver fat content (percent) measured by magnetic resonance imaging - Proton density fat fraction (MRI-PDFF)|Relative change in liver stiffness measured by MRE|NASH resolution (defined by the NASH CRN as lobular inflammation 0 - 1 and ballooning 0)|Change in stage of fibrosis according to the NASH CRN fibrosis score|Change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) according to the NASH CRN criteria|Number of treatment emergent adverse events
Sponsor/Collaborators: Novo Nordisk A/S
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 65
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: June 18, 2019
Completion Date: June 10, 2021
Results First Posted: --
Last Update Posted: December 1, 2021
Locations: Novo Nordisk Investigational Site, Chandler, Arizona, United States|Novo Nordisk Investigational Site, Peoria, Arizona, United States|Novo Nordisk Investigational Site, Coronado, California, United States|Novo Nordisk Investigational Site, La Jolla, California, United States|Novo Nordisk Investigational Site, Rialto, California, United States|Novo Nordisk Investigational Site, Boca Raton, Florida, United States|Novo Nordisk Investigational Site, Gainesville, Florida, United States|Novo Nordisk Investigational Site, Miami, Florida, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, United States|Novo Nordisk Investigational Site, Marietta, Georgia, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, United States|Novo Nordisk Investigational Site, South Bend, Indiana, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, United States|Novo Nordisk Investigational Site, Boston, Massachusetts, United States|Novo Nordisk Investigational Site, Detroit, Michigan, United States|Novo Nordisk Investigational Site, Durham, North Carolina, United States|Novo Nordisk Investigational Site, Germantown, Tennessee, United States|Novo Nordisk Investigational Site, Hermitage, Tennessee, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, United States|Novo Nordisk Investigational Site, Arlington, Texas, United States|Novo Nordisk Investigational Site, Dallas, Texas, United States|Novo Nordisk Investigational Site, San Antonio, Texas, United States|Novo Nordisk Investigational Site, Richmond, Virginia, United States|Novo Nordisk Investigational Site, Clichy, France|Novo Nordisk Investigational Site, Lyon Cedex 4, France|Novo Nordisk Investigational Site, Paris, France|Novo Nordisk Investigational Site, Paris, France|Novo Nordisk Investigational Site, Venissieux, France|Novo Nordisk Investigational Site, Frankfurt, Germany|Novo Nordisk Investigational Site, Leipzig, Germany|Novo Nordisk Investigational Site, Mainz, Germany|Novo Nordisk Investigational Site, Barcelona, Spain|Novo Nordisk Investigational Site, Sevilla, Spain|Novo Nordisk Investigational Site, Birmingham, United Kingdom|Novo Nordisk Investigational Site, London, United Kingdom|Novo Nordisk Investigational Site, Newcastle upon Tyne, United Kingdom|Novo Nordisk Investigational Site, Nottingham, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT03987451

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D327 Semaglutide Chemical drug DB13928 GLP1R agonist Antidiabetic drug Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details