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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Sep 3, 2027
See other at-risk trials from National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Record History

The 50 most recent of 213 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Sep 3, 2027 Completion pushed from Oct 2, 2026 to Dec 31, 2027v213 Show 1 more changeShow less
    • Completion pushed from Oct 2, 2026 to Dec 31, 2027
  2. 3 versions Re-verified since Jul 7, 2026, no change to tracked fieldsv210-v212
  3. Enrollment increased: 84 → 104 participantsv209
  4. 6 versions Re-verified since Oct 23, 2024, no change to tracked fieldsv203-v208
  5. Primary completion date: Aug 1, 2025 to Aug 31, 2026 Completion date: Aug 1, 2025 to Oct 2, 2026v202 Show 1 more changeShow less
    • Completion date: Aug 1, 2025 to Oct 2, 2026
Show 38 earlier versionsHide 38 earlier versions
  1. 2 versions Re-verified since Aug 31, 2024, no change to tracked fieldsv200-v201
  2. Eligibility criteria shortened, about 1 word Study description shortened, about 2 wordsv199 Show 1 more changeShow less
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025v198
  4. 4 versions Re-verified since Feb 17, 2024, no change to tracked fieldsv194-v197
  5. Study description revisedv193 See this version in full on ClinicalTrials.gov ↗
  6. Eligibility criteria expanded, about 12 wordsv192 See this version in full on ClinicalTrials.gov ↗
  7. 11 versions Re-verified since Nov 4, 2022, no change to tracked fieldsv181-v191
  8. Primary and study completion dates: Jan 31, 2023 to Aug 1, 2024v180
  9. 16 versions Re-verified since Jun 10, 2022, no change to tracked fieldsv164-v179
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. ...
Trial Details
NCT Number NCT03884075
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: National Cancer Institute (NCI)
Conditions Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov