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

NCT06599918 | Recruiting Phase 2 DMC

• 2 other identifiers: IIBSP-NIC-2021-1572023-504100-28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatty Liver; Obesity; Hepatic Fibrosis; NAFLD; Nicotinamide; Overweight and Obese Adults

Keywords

Nicotinamide; Fatty liver; Nafld

Outcome Measures

Primary Outcomes (1)

• Effect of nicotinamide on hepatic fibrosis

  Measurement of hepatic fibrosis by Fibroscan, to asses the arrest or improvement of fibrosis (lower value than basal Fibroscan result)

  Fibroscan at 0 and 12 months.

Secondary Outcomes (10)

• Effect of nicotinamide on body fat and hepatic fat distribution

  0 and 12 months

• Effect of nicotinamide on the general health state (weight)

  Blood test and strength test at 0, 3, 6, and 12 months

• Effect of nicotinamide on the general health state (strenght)

  Blood test and strength test at 0, 3, 6, and 12 months

• Effect of nicotinamide on the Insulin resistance

  Blood test and strength test at 0, 3, 6, and 12 months

• Effect of nicotinamide on gut microbiota

  Test at 0, 3, 6, and 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Administration of the placebo compound, in the same format as the active compound. The placebo is composed by microcrystalline Cellulose (Excipient No. 1 for capsules: 98.05% microcrystalline cellulose, 1.95% colloidal silica). Molecular formula: C14H26O11 IUPAC name: methyl 4-O-methyl-hexopyranosyl-(1-\>4)-hexopyranoside Molecular weight: 370.35 g/mol Qualitative and quantitative composition (per capsule): Microcrystalline Cellulose 400 mg Pharmaceutical form: Hard gelatin capsules containing. Dose and route of administration: maximum 2.4 g daily/oral. Raw material suppliers: Fagron and Acofarma. Encapsulation location: Pharmacy Service of HSCSP.

Drug: Placebo

Nicotinamide

ACTIVE COMPARATOR

Administration of the active compound, the amide form of vitamin B3, Nicotinamide (NAM). International Nonproprietary Name: Nicotinamide. Molecular formula: C6H6N2O IUPAC name: Pyridine-3-carboxamide. Molecular weight: 122.12 g/mol. Qualitative and quantitative composition (per capsule): Nicotinamide 500 mg. Pharmaceutical form: Hard gelatin capsules. Dose and route of administration: maximum 3 g daily/oral. Raw material suppliers: Fagron and Acofarma. Encapsulation location: Pharmacy Service of HSCSP.

Drug: Nicotinamide

Interventions

Nicotinamide DRUG

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

Also known as: NAM

Nicotinamide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients with iodinated contrast allergy.
• History or evidence of an autoimmune disorder considered clinically significant by the investigator or requiring systemic, chronic use of systemic corticosteroids or other immunosuppressants.
• Patients on treatment with hepatotoxic drugs (amiodarone, immunosuppressants, ART, antituberculosis drugs, corticosteroids, etc.).
• Patients consuming narcotic and psychotropic substances with hepatotoxic effects.
• Individuals with incapacitating diseases or cognitive impairment.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Fatty Liver; Obesity; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Overweight

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Didac Mauricio, Md PhD

CONTACT

003493 556 57 75; dmauricio@santpau.cat

Josep Julve, PhD

CONTACT

0034935565617; jjulve@santpau.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be double-blind. The delivery of the investigational product will not contain information about the assigned treatment arm or the administered dose. Both interventions will have the same presentation format and identical visual characteristics. Therefore, both the patient and the Endocrinology specialist facilitating the intervention will be unaware of the assigned treatment arm. All personnel from the sponsor and investigator's center involved in the study will undergo masking concerning the assigned treatment, with the following exceptions: The pharmacy staff at the center involved in the preparation. The Pharmacy Service at Sant Pau Hospital will mask the study medication, labeling it with consecutive code numbers following the randomization table. The sponsor's pharmacovigilance personnel reporting adverse events to health authorities.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A controlled, randomized, double-blind, and multicenter clinical trial has been designed to explore the proof-of-concept regarding the effects of nicotinamide (NAM) administration on hepatic inflammation and fibrosis in individuals with a BMI over 27. The trial adopts a parallel design, incorporating a placebo control group.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: September 19, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

ES (1)