Actively Recruiting
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
84
Participants Needed
1
Research Sites
375 weeks
Total Duration
On this page
Sponsors
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. ...
CONDITIONS
Official Title
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histological evidence of liver fat on biopsy within 12 months or fatty liver shown by imaging within 12 months
- Average alcohol consumption less than 30 g/day for men or less than 20 g/day for women in the 6 months before enrollment without binge drinking
- Ability to understand and sign informed consent
- For treatment phase: NAFLD with steatosis grade ≥1 on liver biopsy at baseline
- Liver fat content ≥10% by 1H-MRS at initial admission
- Healthy volunteers must have no liver fat by imaging or biopsy
- Healthy volunteers must have BMI ≤ 25 kg/m²
- Healthy volunteers must be non-diabetic with normal liver enzymes and fasting glucose
You will not qualify if you...
- Pregnant or breastfeeding
- Chronic hepatitis B or C infection unless successfully treated and off therapy for >18 months
- HIV infection
- Other liver diseases such as autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, etc.
- Drug-induced liver injury unless stable liver enzyme levels for 6 months
- Advanced liver disease with specific abnormal lab values or history of complications
- Use of medications causing fatty liver disease
- Uncontrolled thyroid disease or suspicious thyroid nodules
- Active or recent coronary artery disease without clearance
- Congestive heart failure
- Chronic kidney disease with low kidney function
- Uncontrolled diabetes with HbA1c >9%, or use of certain diabetes medications
- Contraindications to liver biopsy or MRI
- History of bariatric surgery or malabsorption
- Use of orlistat or uncontrolled eating disorders
- Proliferative diabetic retinopathy
- Use of medications or supplements for NAFLD unless stable or withdrawn >3 months
- Liver biopsy within 2 years unless willing to undergo research biopsies
- Inability or unwillingness to receive injections
- Allergy to trial medication or components
- Alcohol or substance abuse in past 12 months
- Women of childbearing potential not willing to use contraception
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Current intensive weight loss regimen or recent significant weight loss
- Use of investigational drugs within 3 months
- Investigator judgment of inability to complete study or safety concerns
- For healthy volunteers: excessive alcohol use, pregnancy, or investigator judgment of unsuitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
Y
Yaron Rotman, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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