A Randomized, Double-Blind, Parallel-Group Clinical Research Study to Assess the Efficacy of Essentiale on Hepatic Steatosis Added to Standard of Care in comparison to Placebo Added to Standard of Care, in Non-Alcoholic Fatty Liver Disease (NAFLD) Connected with Type 2 Diabetes Mellitus (T2DM) and/or abnormally high levels of fats (lipids) in the blood (Hyperlipidemia) and/or abnormal accumulation of body fat (Obesity)
- Conditions
- on-alcoholic fatty liver disease associated with type 2 diabetes mellitus and/or hyperlipidemia and/or obesityMedDRA version: 25.0Level: LLTClassification code 10082249Term: Nonalcoholic fatty liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2021-006069-39-PL
- Lead Sponsor
- Sanofi-Aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 190
- Is capable of understanding the written informed consent, provides signed written informed consent, is willing and able to complete the electronic diary (eDiary), and agrees to comply with protocol requirements.
- Is an adult male or female, 18 to 70 years (both inclusive) of age.
- Was diagnosed with NAFLD.
- Presents with steatosis score of S1–S3 (defined as CAP score >248 decibels per meter [dB/m], as measured by transient elastography).
- Presents with liver fibrosis score of F1–F3 (defined as LSM of 5-13 kilopascals [kPa], as measured by transient elastography).
- Has confirmed diagnosis of at least one of the following associated illnesses:
o T2DM and has been treated with diabetes medications (eg, metformin, insulin) with stable doses for 3 months, as judged by the investigator, before the patient enrollment visit, and is willing to continue their medications during the trial.
o Hyperlipidemia (defined as presence of abnormally elevated levels of any or all lipids or lipoproteins in the blood) and has been treated with hyperlipidemia medications (eg, statins) with stable doses for 3 months, as judged by the investigator, before the patient enrollment visit, and is willing to continue their medications during the trial.
o Obesity (defined as body mass index [BMI] =30 kg/m2).*
*Body weight and height will be recorded for the calculation of BMI
(metric: BMI = weight [kg]/[height (m)]2).
- Is willing to follow lifestyle modification (diet and physical activity/exercise), as recommended by the investigator, and agrees to maintain these modifications during the trial period.
(Note: In order to encourage stable and sustainable lifestyle modification among patients during the conduct of this trial, sites will be encouraged to apply site- and disease-specific SoC or apply 2016 European Association for the Study of the Liver [EASL] guidelines (EASL et al 2016). In either case, SoC refers to lifestyle modification, whose common denominator across trial sites potentially could be summarized as a measure to decrease body fat and weight.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
Patients meeting any of the following criteria (at the patient enrollment visit) will be excluded from the trial:
- Has other causes of liver disease or abnormal laboratory results (AST =4 × upper limit of normal [ULN], ALT =4 × ULN, bilirubin =2 × ULN), or cirrhosis within 3 months before the patient enrollment visit.
- Has current viral hepatitis.
- Has been diagnosed with type 1 diabetes mellitus (T1DM).
- Has an HbA1c >10.0% within 3 months before the patient enrollment visit.
- Has severe heart disease (eg, heart failure), according to New York Heart Association (NYHA) Functional Classification (Class II–IV; The Criteria Committee of the New York Heart Association 1994) or severe renal impairment, as defined by estimated glomerular filtration rate of <15 mL/min/1.73 m2.
- Has current or known history of drug abuse within 6 months before the patient enrollment visit.
- Has current or known history of alcohol consumption >20 g per day in women or >30 g per day in men.
- Is enrolled in another clinical trial or has taken other investigational drug(s) within 1 month before the patient enrollment visit.
- Is not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or potentially is at risk of noncompliance to trial procedures.
- Has hypersensitivity to Essentiale or its components or any of its excipients that, in the opinion of the investigator, contraindicates participation in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method