Clinical Trial

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

Study acronym: NICOFIB
Recruiting Phase 2
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Summary
The objective of this clinical trial, a pilot study, is to assess the impact of nicotinamide (NAM) on individuals with hepatic fibrosis. The main question it aims to answer is: \- To determine if the treatment with NAM is able to arrest, or even reduce, the hepatic fibrosis. In addition, we also want to study the effect of NAM on: * General parameters (weight, HOMA-IR, etc). * Adiposity distribution (liver and body). * Systemic inflammation. * Thermogenic capacity of adipose tissue. * Microbiota composition. Researchers will compare NAM to a placebo, to see if NAM can arrest or revert hepatic fibrosis and its associated effects. Participants will take either NAM or placebo. The dosage will be 1.2g/m2 NAM per day, for one year.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-12.
Trial Details
NCT Number NCT06599918
Lead Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Germans Trias i Pujol Hospital
Conditions Fatty Liver, Obesity, Hepatic Fibrosis, NAFLD, Nicotinamide, Overweight and Obese Adults
Enrollment 30 participants
Start Date 2024-04-23
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-18