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Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT06599918•Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

View on ClinicalTrials.gov

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.

Detailed Description

Patients with a Fibroscan \> 8 kPa will be offered to participate in this study. Participants will receive either placebo or a NAM dose adjusted to body weight. The duration of the treatment is 12 months. Participants will be subjected to a total of 5 follow-up and/or control visits: Visit 1 * Physical examination(weight, height, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Assessment of muscle status and risk of sarcopenia: grip strength, chair test. * Basal electrocardiogram. * Blood analysis. * Bioelectrical impedance analysis. * Nuclear magnetic resonance. * Thermographic image. * Food questionnaire (PREDIMED). * International Physical Activity Questionnaire (IPAQ). * Collection of blood, urine, and feces samples for storage in the biobank. Visit 2. Control visit (time month 1) * Monitoring of adverse events (AE) and adverse reactions (AR). * Electrocardiogram. * Control blood analysis: sodium, potassium, liver biochemistry (AST, ALT, bilirubin, GGT, FA), renal function (urea, creatinine, estimated glomerular filtration), and coagulation tests. * Physical examination and measurement of vital signs. Visit 3. Follow-up visit (time month 3) * Monitoring of AE and AR. * Drug adherence questionnaire. * Electrocardiogram. * Blood analysis. * Physical examination (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Collection of blood, urine, and feces samples for biobank. * Collection of concomitant medication. * Adherence to study treatment and dietary recommendations. Visit 4. Follow-up visit (time month 6) * Monitoring of AE and AR. * Drug adherence questionnaire. * Electrocardiogram. * Blood analysis. * Physical examination (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Collection of blood, urine, and feces samples for biobank. * Collection of concomitant medication. * Adherence to study treatment and dietary recommendations. Visit 5. Control visit (time month 9). * Monitoring of AE and AR. * Drug adherence questionnaire. * Electrocardiogram. * Control blood analysis. * Physical examination. * Collection of concomitant medication. Visit 6. Final exploration (time month 12) * Monitoring of AE and AR. * Drug adherence questionnaire. * Food questionnaire (PREDIMED). * Physical Activity Questionnaire (IPAQ). * Physical examination and measurement of vital signs (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Assessment of muscle status and risk of sarcopenia: FPM, chair test. * Electrocardiogram. * Blood analysis. * Measurement of NAM and derived metabolites in serum and urine. * Nuclear magnetic resonance. * Bioimpedance. * Thermographic image. * Fibroscan® with CAP. * Collection of blood, urine, and feces samples for biobank The safety of the participants will be assessed using a record of the AEs and ARs that could arise and their annotation in the EDC, as well as a regular evaluation of liver, kidney, and heart function at baseline, 1, 3, 6, 9 and 12 months

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged between 18 and 85 years.
•Diagnosis of non-alcoholic fatty liver disease (NAFLD) by their referring physicians (NAFLD defined as the presence of hepatic steatosis and in the absence of significant alcohol consumption, having excluded other liver diseases).
•BMI between 27-40 kg/m2.
•Fibroscan® value greater than 9.2 kPa, obtained within the last 6 months prior to the start of the study.

Exclusion Criteria

•Patients with any medical condition or illness that, in the opinion of the investigator, could interfere with the study results and/or affect the patients' ability to participate or complete the study.
•History of clinically significant heart disease (ejection fraction \<40% \[normal range 50-70%\], heart failure defined as New York Heart Association \[NYHA\] Class \> 2; clinically significant congenital or acquired valvular disease; symptomatic coronary artery disease such as myocardial infarction or angina, history of unstable arrhythmias, history of atrial fibrillation).
•Decreased renal function (estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the CKD-EPI formula) at screening.
•Alcohol consumption exceeding 30 g/day in men or 20 g/day in women.
•Patients with significant impairment of liver function in the selection analysis defined as repeated values of AST, ALT, and bilirubin \> 3 times the upper limit of normal.
•Positive for hepatitis B surface antigen or hepatitis C antibodies.
•Patients with hepatocellular carcinoma.
•Patients with liver cirrhosis (Fibroscan® \> 18, compatible biopsy, or those who have experienced decompensations of cirrhosis).
•Patients diagnosed with human immunodeficiency virus (HIV).
•Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of capsules (NAM and placebo).
+20 more criteria

Locations (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Key Dates

Start Date

April 23, 2024

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2028

Last Updated

November 18, 2025

Enrollment

ESTIMATED participants

Conditions

Fatty LiverObesityHepatic FibrosisNAFLDNicotinamideOverweight and Obese Adults

Interventions

Nicotinamide

DRUG

Placebo

DRUG

Contacts

Didac Mauricio, Md PhD

CONTACT

003493 556 57 75 dmauricio@santpau.cat

Josep Julve, PhD

CONTACT

0034935565617 jjulve@santpau.cat

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

Natural History of Noncirrhotic Portal Hypertension

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