Fatty LiverPhase 2NICOFIBNCT06599918
Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
A Phase 2 study testing Nicotinamide in people with Fatty Liver and Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fatty Liver, Obesity, Hepatic Fibrosis
- What is being tested?
- Nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 23 Apr 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Irina Espinosa, 003493 556 5617, uicec@santpau.cat
Yaira Mathison, 003493 556 5617, ymathison@santpau.cat
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)
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:
Read more
- 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.
Read the 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
- Conditions
- Fatty Liver, Obesity, Hepatic Fibrosis, NAFLD, Nicotinamide, Overweight and Obese Adults
- Being tested
- Nicotinamide, Placebo
- Keywords
- Nicotinamide, Fatty liver, Nafld
- Medical subject headings
- Fatty Liver, Obesity, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDrug
Also called NAM
Administration of NAM on a variable dose depending on the participant's body weight. Administration is done orally, daily.
PlaceboDrug
Administration of placebo on a variable dose depending on the participant's body weight. Administration is done orally, daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Fibroscan at 0 and 12 months.
Secondary outcomes (10)
Effect of nicotinamide on body fat and hepatic fat distribution
Analysis of body and hepatic fat by magnetic ressonance and observe visual differences between the basal and final images
Measured: 0 and 12 months
Effect of nicotinamide on the general health state (weight)
Analysis of body weight (grams) and waist circumference (cm), a reduction in both would point to a better general status and a weight loss
Measured: Blood test and strength test at 0, 3, 6, and 12 months
Effect of nicotinamide on the general health state (strenght)
Evaluation of the grip strength as a measure of muscle strength
Measured: Blood test and strength test at 0, 3, 6, and 12 months
Effect of nicotinamide on the Insulin resistance
Calcutaltion of the HOMA-IR (homeostatic model assessment - Insulin Resistance) index, a reduction of the HOMA-IR index shows a reduction of insulin resistance and an improved glucose metabolism
Measured: Blood test and strength test at 0, 3, 6, and 12 months
Effect of nicotinamide on gut microbiota
Analyses of the gut microbiota composition during the NAM treatment
Measured: Test at 0, 3, 6, and 12 months
Effect of nicotinamide on systemic inflammation
Analysis of the evolution of systemic inflammation by ELISA (enzyme-linked immunosorbent assay) of several cytokines related to inflammation. Lower values are usually associated to lower inflammation.
Measured: Blood test at 0, 3, 6, and 12 months
Effect of nicotinamide on cellular inflammation
Analysis of the evolution of cellular inflammation by analyzing the count and type of peripheral blood mononuclear cells by flow-cytometry
Measured: Blood test at 0, 3, 6, and 12 months
Security evaluation LIVER
Security evaluation of the dosage of nicotinamide administered by analyzing liver parameters of aspartate transaminase (AST), alanine transaminase (ALT), and coagulation parameters.
Measured: 0, 1, 3, 6, 9, and 12 months
Security evaluation KIDNEY
Security evaluation of the dosage of nicotinamide administered by measuring glomerular filtrate and creatinine
Measured: 0, 1, 3, 6, 9, and 12 months
Effect of nicotinamide on liver parameters
Evaluation of the effects of nicotinamide on liver status by ELF-test, to observe if there is any improvement (lower value than basal measurement)
Measured: 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599918
- Sponsor's protocol ID
- IIBSP-NIC-2021-157
- Other IDs
- 2023-504100-28, 2023
- Acronym
- NICOFIB
- Status last verified
- Oct 2025
- First submitted
- 11 Jul 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)
- ClinicalTrials.gov ID
- NCT06599918
- Acronym / sponsor ID
- NICOFIB / IIBSP-NIC-2021-157
- Conditions
- Fatty Liver, Obesity, Hepatic Fibrosis, NAFLD, Nicotinamide, Overweight and Obese Adults
- Keywords
- Nicotinamide, Fatty liver, Nafld
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdministration 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. |
| Nicotinamide | Active comparator | Drug: NicotinamideAdministration 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotinamideAlso: NAMAdministration of NAM on a variable dose depending on the participant's body weight. Administration is done orally, daily. | Drug | Nicotinamide |
| PlaceboAdministration of placebo on a variable dose depending on the participant's body weight. Administration is done orally, daily. | Drug | Placebo |
Primary outcome
Effect of nicotinamide on hepatic fibrosis
Time frame: Fibroscan at 0 and 12 months.
Measurement of hepatic fibrosis by Fibroscan, to asses the arrest or improvement of fibrosis (lower value than basal Fibroscan result)
10 secondary outcomes
Effect of nicotinamide on body fat and hepatic fat distribution
Time frame: 0 and 12 months
Effect of nicotinamide on the general health state (weight)
Time frame: Blood test and strength test at 0, 3, 6, and 12 months
Effect of nicotinamide on the general health state (strenght)
Time frame: Blood test and strength test at 0, 3, 6, and 12 months
Effect of nicotinamide on the Insulin resistance
Time frame: Blood test and strength test at 0, 3, 6, and 12 months
Effect of nicotinamide on gut microbiota
Time frame: Test at 0, 3, 6, and 12 months
Effect of nicotinamide on systemic inflammation
Time frame: Blood test at 0, 3, 6, and 12 months
Effect of nicotinamide on cellular inflammation
Time frame: Blood test at 0, 3, 6, and 12 months
Security evaluation LIVER
Time frame: 0, 1, 3, 6, 9, and 12 months
Security evaluation KIDNEY
Time frame: 0, 1, 3, 6, 9, and 12 months
Effect of nicotinamide on liver parameters
Time frame: 0 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide in people with Fatty Liver and Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didac Mauricio, Md PhD (003493 556 57 75, dmauricio@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nicotinamide on hepatic fibrosis (time frame: Fibroscan at 0 and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.