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NCT03884075 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Recruiting
Registry status
Phase 2
Development phase
84
Enrollment target
1
Study location

NCT03884075 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 84 participants, below the 188-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03884075, a Phase 2 study of Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

RECRUITING
Registry status
Phase 2
Development phase
84 participants
Enrollment target
1
Study location

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 Studied

Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis

Interventions

  • DRUG Semaglutide

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2019-07-24
Est. Completion 2026-10-02
Phase Phase 2

Sponsor

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

490 total trials

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What the Registry Record Tells You About NCT03884075

The ClinicalTrials.gov registry entry for NCT03884075 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (55% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Semaglutide is the first listed.

NCT03884075 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03884075 about?

NCT03884075 is a clinical study titled "Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)". 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 rel...

What is the current status of trial NCT03884075?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2019-07-24. Estimated completion is 2026-10-02.

What conditions does trial NCT03884075 study?

This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis.

What interventions are being tested in trial NCT03884075?

The interventions under investigation include: Semaglutide (DRUG).

Who is sponsoring clinical trial NCT03884075?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03884075 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.