Study Details
Novo Nordisk: NASH and semaglutide
(IRB#: IRB_00139687)
We are doing this study to see if the medicine called semaglutide can help patients with NASH get better and reduce their risk of future liver complications. NASH is a disease where fat, inflammation and scar tissue build up in the liver. Semaglutide may improve these liver damages. By improving liver damage it might be possible to prevent future liver complications. Semaglutide is already used by doctors to treat patients with type 2 diabetes in many countries. It is also used in research studies of patients with obesity and of patients with different stages of NASH.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
Exclusion Criteria
- Documented causes of chronic liver disease other than NAFLD
- Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
- Known or suspected excessive consumption of alcohol (>20 g/day for women or >30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
- Treatment with vitamin E (at doses 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
Will I be paid for my time?
Yes
IRB#: IRB_00139687
PI: Tuan Pham
Department: GASTROENTEROLOGY
Approval Date: 2021-11-03 06:00:00
Specialties: Gastroenterology