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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis

In brief

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 facts

Study ID

NCT03987451

Run by

Novo Nordisk A/S

People needed

71

Starts

2019-06-18

Expected to finish

2021-06-10

Last updated by the study team

2024-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
• Histologic evidence of NASH and fibrosis stage 4 according to the NASH CRN classification based on central pathologist evaluation of a liver biopsy obtained within 360 days prior to screening. In subjects who have never had a liver biopsy showing NASH and F4, liver stiffness above 14 kPa by FibroScan® at screening must be documented before subjects can have a trial-related liver biopsy
• A histological NAFLD activity score (NAS) equal to or above 3 with a score of 1 or more in lobular inflammation and hepatocyte ballooning based on central pathologist evaluation
• Body mass index equal to or above 27 kg/m\^2

You may not qualify if…

• Presence or history of hepatic decompensation (e.g. ascites, variceal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis) or liver transplantation
• Presence or history of gastroesophageal varices within the past 360 days prior to screening. For subjects with no known history of gastroesophageal varices and with a Fibroscan® equal to or above 20 kPa and thrombocytes equal to or below 150,000, a esophagogastroduodenoscopy must be performed to evaluate presence of gastroesophageal varices
• Presence or history of hepatocellular carcinoma
• Treatment with vitamin E (at doses equal to or above 800 IU/day) or pioglitazone which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to screening
• Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in the period from 90 days prior to screening
• Treatment with other glucose lowering agent(s) (apart from what is listed in the exclusion criterion above) or weight loss medication not stable in the opinion of the investigator in the period from 28 days prior to screening

Where it is running

• Arizona Liver Health — Chandler, Arizona, United States
• The Institute for Liver Health dba Arizona Liver Health — Peoria, Arizona, United States
• Southern California Research Center — Coronado, California, United States
• Altman Clinical Translational Research Institute — La Jolla, California, United States
• Inland Empire Clinical Trials LLC — Rialto, California, United States
• Excel Medical Center Clinical Trials, LLC — Boca Raton, Florida, United States
• University of Florida-CTRB — Gainesville, Florida, United States
• University of Miami/Schiff Center for Liver Diseases — Miami, Florida, United States
• Piedmont Research Institute — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Digestive Research Alliance of Michiana — South Bend, Indiana, United States
• University of Kentucky Hospital — Lexington, Kentucky, United States
• Mercy Medical Center, GI Research — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Duke University — Durham, North Carolina, United States
• Gastroenterology Center For The Mid-South — Germantown, Tennessee, United States
• Digestive Health Research - Tristar Summit Medical Center — Hermitage, Tennessee, United States
• Quality Medical Research — Nashville, Tennessee, United States
• Texas Clinical Research Institute, LLC — Arlington, Texas, United States
• The University of Texas Southwestern Medical Center - Dallas — Dallas, Texas, United States
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States
• VCU Health Systems — Richmond, Virginia, United States
• Hôpital Beaujon — Clichy, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.