A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Novo Nordisk A/S
Study ID
NCT03987451
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks
  • Placebo (semaglutide) — DRUG
    Semaglutide placebo s.c. given once-weekly for 48 weeks

Study Details

Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Key Dates

Start date
Jun 18, 2019
Status verified
May 2024
Primary completion
Apr 22, 2021
Completion
Jun 10, 2021

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Dose escalation to 2.4 mg of semaglutide once-weekly
  • Placebo Comparator: Placebo
    Semaglutide placebo once-weekly

Primary Outcome Measure

Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks [ Time Frame: Week 48 ]

Locations (24)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224-
The Institute for Liver Health dba Arizona Liver HealthPeoriaArizona85381-
Southern California Research CenterCoronadoCalifornia92118-
Altman Clinical Translational Research InstituteLa JollaCalifornia92037-
Inland Empire Clinical Trials LLCRialtoCalifornia92377-
Excel Medical Center Clinical Trials, LLCBoca RatonFlorida33434-
University of Florida-CTRBGainesvilleFlorida32610-
University of Miami/Schiff Center for Liver DiseasesMiamiFlorida33136-
Piedmont Research InstituteAtlantaGeorgia30309-
Gastrointestinal Specialists of GeorgiaMariettaGeorgia30060-
Indiana UniversityIndianapolisIndiana46202-
Digestive Research Alliance of MichianaSouth BendIndiana46635-
University of Kentucky HospitalLexingtonKentucky40508-
Mercy Medical Center, GI ResearchBaltimoreMaryland21202-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48202-
Duke UniversityDurhamNorth Carolina27710-
Gastroenterology Center For The Mid-SouthGermantownTennessee38138-
Digestive Health Research - Tristar Summit Medical CenterHermitageTennessee37076-
Quality Medical ResearchNashvilleTennessee37211-
Texas Clinical Research Institute, LLCArlingtonTexas76012-
The University of Texas Southwestern Medical Center - DallasDallasTexas75390-8887-
American Research Corporation at the Texas Liver InstituteSan AntonioTexas78215-
VCU Health SystemsRichmondVirginia23298-

Find similar trials in Chandler, AZ

By research site
Arizona Liver Health· Chandler, AZThe Institute for Liver Health dba Arizona Liver Health· Peoria, AZSouthern California Research Center· Coronado, CAAltman Clinical Translational Research Institute· La Jolla, CAInland Empire Clinical Trials LLC· Rialto, CAExcel Medical Center Clinical Trials, LLC· Boca Raton, FL

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