Testing Nicotinamide Treatment to Stop or Reverse Liver Fibrosis in Adults With Fatty Liver Disease

What this Trial Is About

This clinical trial is a pilot study investigating the effects of nicotinamide NAM on people with hepatic fibrosis, a liver condition. Researchers aim to determine if NAM treatment can stop or reduce liver fibrosis and study its impact on general health factors like weight, insulin resistance, fat distribution, inflammation, fat tissue activity, and gut microbiota composition. The study compares NAM to a placebo to understand these effects better. Participants will receive either NAM or a placebo adjusted to their body weight, taken orally every day for one year. The NAM dose is 1.2 gm2 per day. The study includes six visits over 12 months, starting with a thorough initial assessment including physical exams, muscle function tests, electrocardiograms, blood tests, imaging, thermography, questionnaires, and sample collection. Follow-up visits monitor safety, adherence, and health status with repeated tests and sample collections. Participants will be closely monitored through physical exams, blood and urine tests, imaging, and questionnaires at various points during the year. Researchers will evaluate liver fibrosis using Fibroscan at the start and end of the study and assess other health measures at multiple timepoints. Safety is tracked by recording any adverse events and regularly checking liver, kidney, and heart function. The study concludes after 12 months of treatment and evaluations.

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)