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MEDFAST: Mediterranean Diet + Intermittent Fasting vs Naltrexone/Bupropion for Liver Fibrosis

NCT06845345Phase 4

Key facts

Status: Enrolling by invitation
Start: Apr 2025
Primary completion: Jul 2027
Countries: 1
Modality: Small Molecules

Drugs: naltrexonebupropion
Conditions: Liver Fibrosis (LF)hepatic steatosis

Overview

Phase 4, randomised, open-label trial of naltrexone and bupropion in Liver Fibrosis (LF) and hepatic steatosis (2 arms). Primary endpoint: Absolute change in liver fibrosis at 6 months. Started Apr 2025; status: enrolling by invitation.

Design

2 arms

Study design: RandomizedOpen-label

Dietary arm
Calorie restricted Mediterranean diet with intermittent fasting
Pharmacological arm
Mysimba (naltrexone/bupropion)

Who it enrols

Adults aged 18-75 with BMI > 30 (or > 27 with cardiometabolic risk factors) and moderate to severe liver fibrosis, excluding those with other liver pathologies, severe renal disease, active malignancies, or excessive alcohol consumption.

Endpoints

Primary

Absolute change in liver fibrosis6 months

Secondary

Absolute change in liver steatosis6 months
Change in weight6 months
Change in height6 months
Change in waist circumference6 months
Change in body composition6 months
Change in grip strength6 months
Change in glycaemic regulation6 months
Change in cholesterol6 months

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