Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Status:
Recruiting
Trial end date:
2023-01-31
Target enrollment:
Participant gender:
Summary
Background:
In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause
damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication
can help.
Objective:
To find out how the liver in people with NAFLD responds to feeding, and how this relates to
their response to the drug semaglutide.
Eligibility:
People with NAFLD and healthy volunteers ages 18 and older
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Imaging: A machine will take pictures of the participant s body.
Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This
includes:
Blood, urine, heart, and imaging tests
For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and
fatty tissue.
Participants will be alone in a special room for 5 hours. They will breathe through a tube
under the nostrils. They will have blood drawn several times.
The baseline visit concludes participation for healthy volunteers but NAFLD participants will
contine.
About 6 weeks after discharge, participants will stay in the clinic again and repeat the
tests. They will get their first semaglutide dose by injection.
Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits
include blood tests.
Participants will inject semaglutide once a week at home.
At week 30, participants will stay in the clinic again and repeat the tests.
Participants will have a final visit 12 weeks after stopping treatment. This includes blood
and urine tests.
...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)