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RecruitingPhase 2NCT06599918

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

Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Enrollment

30 participants

Start Date

Apr 23, 2024

Study Type

INTERVENTIONAL

Conditions

ObesityNAFLDFatty LiverHepatic fibrosisOverweight and Obese AdultsNicotinamide

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 pilot study is testing whether nicotinamide (NAM, a form of vitamin B3) can slow or reverse liver scarring (fibrosis) in patients with non-alcoholic fatty liver disease (NAFLD). Liver fibrosis is a buildup of scar tissue that can progress to serious liver damage if untreated, and there are currently limited approved treatments. You may be eligible if you are 18 to 85 years old, have NAFLD with confirmed liver stiffness above 9.2 kPa on Fibroscan, have a BMI between 27 and 40, and do not have advanced liver cirrhosis, hepatitis B or C, HIV, or significant heart or kidney disease. Participation involves taking oral NAM or placebo daily for 12 months, along with blood tests, MRI scans, and clinic visits at multiple points throughout the year. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNicotinamide

Administration of NAM on a variable dose depending on the participant's body weight. Administration is done orally, daily.

DRUGPlacebo

Administration of placebo on a variable dose depending on the participant's body weight. Administration is done orally, daily.

Locations(1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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NCT06599918

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