Who is sponsoring NCT04383951?

NCT04383951 is sponsored by Indiana University.

What drugs are being tested in NCT04383951?

Interventions in NCT04383951: Dietary consult for participants in the ketogenic diet arm, Dietary consult for participants in the standard of care arm.

What condition does NCT04383951 study?

NCT04383951 studies NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver.

Is NCT04383951 still recruiting?

NCT04383951 is currently active, enrolled. Last updated 17 April 2026.

Last reviewed 2026-04-17 · How we verify

NCT04383951

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

Active, enrolled NA Last updated 17 April 2026

What this trial tests

NA trial testing Dietary consult for participants in the ketogenic diet arm in NASH - Nonalcoholic Steatohepatitis in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 August 2020

Primary endpoint
31 December 2024

31 December 2026

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	15 August 2020
Primary completion	31 December 2024
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

Dietary consult for participants in the ketogenic diet arm
Dietary consult for participants in the standard of care arm

Conditions studied

NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
Cirrhosis, Liver — all drugs for Cirrhosis, Liver →

Sponsor

Indiana University

Who can join

18 and older, any sex, with NASH - Nonalcoholic Steatohepatitis or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Different Dietary Approaches, Non-Alcoholic Fatty Liver Disease and Cardiovascular Disease: A Literature Review.
Torres-Peña JD, Arenas-de Larriva AP, Alcala-Diaz JF, Lopez-Miranda J, et al · · 2023 · cited 28× · PMID 36986213 · DOI 10.3390/nu15061483
Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis.
Buzzetti E, Linden A, Best LM, Madden AM, et al · · 2021 · cited 28× · PMID 34114650 · DOI 10.1002/14651858.cd013156.pub2

Verify or expand the search:

Other recruiting trials for NASH - Nonalcoholic Steatohepatitis

Currently open trials in the same condition.

NCT05499949 — The Franciscus Obesity NASH Study · active not recruiting
NCT05023044 — Nonalcoholic Fatty Liver Disease in HIV Database · active not recruiting
NCT04232566 — Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity · recruiting
NCT05165446 — Novel MRE Technique to Assess a Risk Factor for Liver Cancer · active not recruiting
NCT04697810 — Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH) · Phase 2 · recruiting

Other Indiana University trials

Trials by the same sponsor.

NCT07470086 — The Role of Environmental Temperatures in Respiratory Control · NA · not yet recruiting
NCT07470099 — The Role of Breathing Perception in Respiratory Control · NA · not yet recruiting
NCT07179952 — Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA ) · Phase 2 · not yet recruiting
NCT07070804 — Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04383951 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 17 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04383951.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing