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Tests treatment safety and results for Fatty Liver
Official title Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
ClinicalTrials.gov ID: NCT06599918
What this study is testing
What is Nicotinamide?
Nicotinamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for fatty liver.
Also referred to as NAM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- 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 likely can't join 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...
- History of clinically significant heart disease (ejection fraction \ 2; clinically significant congenital or acquired valvular disease; symptomatic...
- 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...
- Positive for hepatitis B surface antigen or hepatitis C antibodies.
See the full eligibility 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...
- 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.
- 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 \ 2; clinically significant congenital or acquired valvular disease; symptomatic coronary artery disease such as myocardial infarction or angina...
- 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 treatment 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.