NCT05463575CompletedPhase 2
Ketohexokinase Inhibition in NAFLD
Metabolic Effects of Ketohexokinase Inhibition on Individuals With Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 24 Jan 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 1 Jul 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 24 Nov 2023
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05463575
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 15
- From 1 Oct 2022 to the primary completion date, 24 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
- Use of drugs that inhibit organic anion transporting polypeptide (OATP) transporters (e.g. rifampicin, gemfibrozil, cyclosporine, erythromycin and clarithromycin)
Other illness
- Type 2 diabetes
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
Other
- Any contra-indication for MRI scanning
- Alcohol consumption of \>3 servings per day for man and \>2 servings per day for woman
- Smoking
- Unstable body weight (weight gain or loss \> 3kg in the last 3 months)
- Engagement in structured exercise activities \> 2 hours a week
- Subjects who do not want to be informed about unexpected medical findings
Who the study is looking for
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Men and (postmenopausal) woman
- Aged ≥ 45 and ≤ 70 years
- Body mass index (BMI) 27 - 35 kg/m2
- Hepatic steatosis (i.e. IHL ≥ 5.56%)
- Stable dietary habits (no weight loss or gain \> 3 kg in the past 3 months)
Age in the registry: 45 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Centre Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.