Ketohexokinase Inhibition in NAFLD

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: Pfizer

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Type 2 diabetes

• Patients with congestive heart failure and and/or severe renal and or liver insufficiency

• Uncontrolled hypertension

• 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

• 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)

• Subjects who do not want to be informed about unexpected medical findings