RecruitingPhase 2NCT03884075

Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)

Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

84 participants

Start Date

Jul 24, 2019

Study Type

INTERVENTIONAL

Conditions

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. ...


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This NIH study (called NAFLD HEROES) investigates non-alcoholic fatty liver disease — a condition where fat builds up in the liver in people who drink little to no alcohol. It tests the drug semaglutide (a medication also used for diabetes and weight loss) to see if it can reduce liver fat and improve liver health. Participants undergo detailed liver assessments including biopsies and specialized MRI scans to measure fat content before and after treatment. The study has two main patient groups: people with confirmed fatty liver disease, and healthy volunteers without liver disease for comparison. The eligibility criteria are detailed because liver biopsies are involved, and many medications and conditions can affect liver health in ways that would confuse the study results. This is a rigorous, carefully controlled NIH clinical trial conducted in the United States. You may be eligible if: - You are 18 years or older - You have confirmed fatty liver disease (by imaging or liver biopsy in the past 12 months) - Your alcohol intake is below 30g/day (men) or 20g/day (women) - Your diabetes (if present) is controlled with HbA1c ≤9% and only on metformin or lifestyle therapy - You are willing to undergo liver biopsies You may NOT be eligible if: - You are pregnant or breastfeeding - You have HIV, active hepatitis B, or hepatitis C infection - You have significant heart, kidney, or advanced liver disease - You use insulin, GLP-1 agonists, or certain diabetes medications - You have had gastric bypass or bariatric surgery - You have a personal or family history of medullary thyroid carcinoma or MEN-2 syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide

Semaglutide injection once weekly


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03884075


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