NCT05463575 (KHKi) is a Phase 2 clinical trial of Ketohexokinase inhibition in NAFLD, sponsored by Maastricht University Medical Center.

Who is sponsoring NCT05463575?

NCT05463575 is sponsored by Maastricht University Medical Center.

What drugs are being tested in NCT05463575?

Interventions in NCT05463575: Ketohexokinase inhibition, Placebo.

Is NCT05463575 still recruiting?

NCT05463575 is currently completed. Last updated 24 January 2024.

Last reviewed 2024-01-24 · How we verify

NCT05463575: KHKi

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

Ketohexokinase Inhibition in NAFLD

Completed Phase 2 Last updated 24 January 2024

What this trial tests

Phase 2 trial testing Ketohexokinase inhibition in NAFLD in 15 participants. Completed in 24 November 2023.

Timeline

1 October 2022

Primary endpoint
24 November 2023

24 November 2023

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	1 October 2022
Primary completion	24 November 2023
Estimated completion	24 November 2023
Sites	1 location across Netherlands

Drugs / interventions tested

Ketohexokinase inhibition — full drug profile →
Placebo

Conditions studied

NAFLD — all drugs for NAFLD →

Sponsor

Maastricht University Medical Center

Who can join

Adults 45 to 70, any sex, with NAFLD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fructose is a big contributor to the development of non-alcoholic fatty liver disease (NAFLD). Inhibiting ketohexokinase (KHK), the enzyme catalyzing the first committed step in fructose metabolism, is thought to reduced intrahepatic lipid (IHL) content. Pharmacological inhibition of KHK resulted in a decrease in IHL content in NAFLD patients, but additional health effects are still unknown. In this study the investigators aim to look at additional health effects following KHK inhibition (KHKi).

Publications & conference data

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

Non-alcoholic fatty liver disease: Immunological mechanisms and current treatments.
Petagine L, Zariwala MG, Patel VB. · · 2023 · cited 27× · PMID 37701135 · DOI 10.3748/wjg.v29.i32.4831
MetALD: Does it require a different therapeutic option?
Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
The Hepatic Axis Fructose-Methylglyoxal-AMPK: Starring or Secondary Role in Chronic Metabolic Disease?
Gugliucci A. · · 2025 · cited 1× · PMID 40429553 · DOI 10.3390/jcm14103559
Roles of short-chain fatty acids in metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis.
Zhang CY, Liu S, Sui YX, Yang M. · · 2025 · PMID 41368119 · DOI 10.4254/wjh.v17.i11.113756

Verify or expand the search:

Other recruiting trials for NAFLD

Currently open trials in the same condition.

NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting
NCT06661655 — Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients · NA · recruiting
NCT07093346 — The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patient · NA · recruiting
NCT06879236 — Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease · recruiting
NCT06888310 — Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease · NA · recruiting

Other Maastricht University Medical Center trials

Trials by the same sponsor.

NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · 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 NCT05463575 (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 Maastricht University Medical Center
Last refreshed: 24 January 2024

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/NCT05463575.

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