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Clinical trial of the efficacy and safety of nicotinamide in patients with diabetes mellitus type 2 and liver fibrosis
EU CTIS ID: 2023-504100-28-00
What this study is testing
To determine the efficacy of NAM administration (1.2 g/m², up to a maximum of 3 g/day) on the development and progression of liver fibrosis, monitored through the use of FibroScan® along with the Enhanced Liver Fibrosis (ELF™) test over a 12-month period in overweight subjects with NAFLD (FibroScan® with CAP >250 dB/m) and early-stage liver fibrosis (FibroScan® >8 kPa).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged between 18 and 85 years.
- Diagnosis of NASH by their referring physicians (NASH defined as presence of hepatic steatosis and in the absence of significant alcohol consumption and having excluded other liver diseases).
- BMI between 27-40 kg/m2.
- Fibroscan® value higher than 8kPa.
- ELF test > 7.7
You likely can't join if
- Patients with any medical condition or disease that, in the opinion of the investigator, could interfere with the results of the study and/or affect the patients' ability to participate in or complete the study.
- Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of the capsules (NAM and placebohard gelatin, microcrystalline cellulose, and colloidal silica).
- 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 being treated with hepatotoxic drugs (amiodarone, immunosuppressants, ART, anti-tuberculosis drugs, corticosteroids, etc.).
- Patients who consume narcotic and psychotropic substances with hepatotoxic effects.
- Individuals with disabling illnesses or cognitive impairment.
See the full eligibility criteria
Who can join
- Patients aged between 18 and 85 years.
- Diagnosis of NASH by their referring physicians (NASH defined as presence of hepatic steatosis and in the absence of significant alcohol consumption and having excluded other liver diseases).
- BMI between 27-40 kg/m2.
- Fibroscan® value higher than 8kPa.
- ELF test > 7.7
What rules you out
- Patients with any medical condition or disease that, in the opinion of the investigator, could interfere with the results of the study and/or affect the patients' ability to participate in or complete the study.
- Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of the capsules (NAM and placebohard gelatin, microcrystalline cellulose, and colloidal silica).
- 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 being treated with hepatotoxic drugs (amiodarone, immunosuppressants, ART, anti-tuberculosis drugs, corticosteroids, etc.).
- Patients who consume narcotic and psychotropic substances with hepatotoxic effects.
- Individuals with disabling illnesses or cognitive impairment.
- Institutionalized patients or patients without a fixed address.
- Principal investigator judgment in case there are indications of low adherence to the trial or follow-up visits.
- People with a life expectancy of less than 12 months.
- Patients participating in another interventional clinical trial, excluding observational/natural history studies, at baseline or within the last 30 days before the start of the study.
- Previous use of vitamin B3 (NAM), abstinence must be at least 3 months before screening.
- 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 pectoris, history of unstable arrhythmias, history of atrial fibrillation).
- Pregnant women as determined by a positive high-sensitivity serum or urine pregnancy test (minimum sensitivity of 25 IU/L or hCG equivalent units) within 24 hours prior to screening, or dosing or completion of the study. Participating women of childbearing potential (WOCBP) will have a pregnancy test (serum or urine) performed 24 hours prior to screening, dosing, or completion of the study. These participants must use a highly effective contraceptive method such as combined hormonal contraceptives or intrauterine device (IUD), according to the Clinical Trial Facilitation Group, throughout the entire study.
- Breastfeeding women.
- Patients who are receiving treatment/supplementation with vitamin E.
- Patients receiving probiotics.
- Patients on the waiting list to undergo 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 (GLP1 analogues, thiazolidinediones, such as pioglitazone) started within 6 months before the start of the study.
- Drugs for the treatment of T2DM with effects on the intestinal microbiota (metformin, α-GI inhibitors, DPP-4 and SGLT-2 inhibitors) initiated within 6 months before the start of the study
- Patients who do not sign the informed consent.
- Decreased renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2, calculated using the CKD-EPI formula) at screening.
- Alcohol consumption greater than 30 g/day in men or 20 g/day in women.
- Patients with significant alteration of liver function in the screening workup 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 hepatocarcinoma. Patients with liver cirrhosis (Fibroscan® > 18, compatible biopsy or who have suffered decompensation of cirrhosis). Patients diagnosed with human immunodeficiency virus (HIV). Patients with hypersensitivity or history of severe allergy to NAM or excipients used in the preparation of the capsules (NAM and placebo). 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 under 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 patients with no fixed abode. Principal investigator criteria in the case of indications of low adherence to the trial or follow-up visits. People with a life expectancy of less than 12 months. Patients participating in another interventional clinical trial, excluding observational/natural history studies, at baseline or in the last 30 days before the start of the study. Prior use of vitamin B3 (NAM), abstinence must be at least 3 months prior to screening.
- Pregnant women as determined by a positive hCG test (serum or urine) at screening or prior to dosing. Participants of childbearing age should use adequate contraception. Nursing women.
- Patients undergoing treatment/supplementation with vitamin E. 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 evolution of liver disease.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.