Intermittent Fasting for NAFLD in Adults

Korábbi kezelés

• Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening \[heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)\].
• Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
• Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of vitamin E can be enrolled in the study.
• Unstable body weight \[defined as: \>10% reduction in body weight in the 6 months prior to the screening visit\]
• Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
• Current or prior history of Child-Pugh score ≥7.
• Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program.

Más betegség

• Evidence of other known forms of chronic liver disease including:
  • Alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
• History of liver transplant, or current placement on a liver transplant list.
• Known positivity for human immunodeficiency virus infection.
• Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation.
• Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.

Laborértékek

• Chronic Kidney Disease (CKD) with eGFR \< 60.

Egyéb

• Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip.
• For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding \[a negative urine pregnancy test is required at screening for women of child-bearing potential\].

• Willing and able to provide informed consent
• Age 18 years or older at time of consent
• BMI 23-30kg/m\^2 at screening
• Evidence of NAFLD confirmed by historical procedure obtained no more than 6 months prior to the screening visit, defined as:
  • Grade \>=1 steatosis on clinical liver biopsy; OR
  • Fatty liver on validated imaging modality (non-contrast CT scan, MR Spectroscopy, MRI proton density fat fraction, ultrasound)
• Liver fat fraction ≥10% on H-MRS performed during the screening period
• Hepatitis C antibody and Hepatitis B surface antigen negative at screening