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

NCT03884075 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-12

No results posted yet for this study

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.

...

Conditions

  • Non-Alcoholic Steatohepatitis
  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Semaglutide

Semaglutide injection once weekly

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

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

    lead NIH

Principal Investigators

  • Yaron Rotman, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2026-08-31
Completion
2026-10-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884075 on ClinicalTrials.gov