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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB) (NCT06599918) is a Phase 2 interventional studying Fatty Liver and Obesity, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Fatty Liver and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 weakened immune system 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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). * 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. * Institutionalized patients or those without a fixed address. * Principal investigator's discretion in case of indications of low adherence to the trial or follow-up visits. * Individuals with a life expectancy of less than 12 months. * Patients participating in another interventional clinical trial, excluding observational/natural history studies, at the start of the study or within the last 30 days before the start of the study. * Previous use of vitamin B3 (NAM), with abstinence required for at least 3 months before screening. * Pregnant women as determined by a positive high-sensitivity serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of hCG) within 24 hours prior to screening, dosing, or completion of the study. Women of childbearing potential (WOCBP) will undergo a pregnancy test (serum or urine) 24 hours prior to screening, dosing, or completion of the study. Such participants must use a highly effective contraceptive method, such as combined hormonal contraceptives or intrauterine device (IUD), in accordance with the Clinical Trial Facilitation Group, throughout the entire study. * Breastfeeding women. * Patients undergoing treatment/supplementation with vitamin E. * Patients receiving probiotics. * Patients on the waiting list for bariatric surgery in the next 12 months. * Patients undergoing treatment with drugs that may have an effect on the progression of liver disease. * Drugs for the treatment of T2DM with effects on NAFLD (GLP-1 analogs, thiazolidinediones such as pioglitazone) initiated within 6 months before the study start. * Drugs for the treatment of T2DM with effects on intestinal microbiota (metformin, α-GI inhibitors, DPP-4 inhibitors, and SGLT-2 inhibitors) initiated within 6 months before the study start. * Patients who do not sign the informed consent. * Patients with contraindications to the contrast agent to be used in imaging tests.

Treatments Being Tested

DRUG

Nicotinamide

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

DRUG

Placebo

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06599918), the sponsor (Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06599918 clinical trial studying?

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 hep… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06599918?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06599918?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06599918. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06599918. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.