A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with non-alcoholic fatty liver disease to see if the medicine is effective and safe in the treatment of that disease.
- Conditions
- MedDRA version: 18.1Level: LLTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 100000004871on- alcoholic steatohepatitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-002560-16-ES
- Lead Sponsor
- Intercept Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2065
1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH with a score of at least 1 for each and a combined score of 4 or greater out of a possible 8 points according to NASH CRN criteria.
2. Histologic evidence of fibrosis stage 2 (perisinusoidal and portal/periportal) or stage 3 (bridging fibrosis) as defined by the NASH CRN scoring of fibrosis, or Histologic evidence of fibrosis stage 1a or stage 1b (mild or moderate, zone 3 perisinusoidal) as defined by the NASH CRN scoring of fibrosis if accompanied by ?1 of the following risk factors:
a. Obesity (body mass index [BMI] ?30 kg/m2)
b. Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria (hemoglobin A1c [HbA1c] ?6.5%, fasting plasma glucose ?126 mg/dL, 2-hour plasma glucose ?200 mg/dL during oral glucose tolerance test, or random plasma glucose ?200 mg/dL)
c. Alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN).
3. Is either not taking or is on stable doses of :
a. TZDs or vitamin E for 6 months before Day 1
b. Therapies for diabetes (excluding TZDs) and weight loss for 90 days before Day 1
c. Allowed concomitant medications and supplements for 30 days before Day 1.
4. Stable body weight (ie, not varying by >10% for at least 3 months) before Day 1.
5. Age ?18 years.
6. Female subjects of childbearing potential must use ?1 effective method of contraception during the study and until 30 days following the last dose of investigational product. Effective methods of contraception are considered to be those listed below
a. Double barrier method, ie, condom (male or female) or diaphragm with spermicide
b. Intrauterine device
c. Vasectomy (partner)
d. Hormonal (eg, contraceptive pill, patch, intramuscular implant or injection)
e. Abstinence (refraining from heterosexual intercourse)
7. Must provide written informed consent and agree to comply with the study protocol.
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 1865
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before Screening (significant alcohol consumption is defined as more than 2 units/day for females and more than 4 units/day for males, on average).
2. Prior or planned (during the study period) bariatric surgery (eg, gastric bands, gastroplasty, roux-en-Y gastric bypass) or ileal resection.
3. HbA1c ?9.0% within 60 days before Day 1.
4. Evidence of other forms of chronic liver disease including:
a. Positive test result at Screening for hepatitis B surface antigen (HbsAg) or hepatitis C (HCV) antibody (and positive HCV ribonucleic acid [RNA])
b. PBC, PSC, autoimmune hepatitis, or overlap syndrome
c. Alcoholic liver disease
d. Wilson?s disease, hemochromatosis, or iron overload
e. Alpha-1-antitrypsin (A1AT) deficiency as defined by diagnostic features in liver histology (confirmed by A1AT level below the lower limit of normal [LLN] or exclusion at the Investigator?s discretion)
f. Prior known drug-induced liver injury within 5 years before Day 1
g. Known or suspected HCC
h. History of liver transplant, current placement on a liver transplant list, or current MELD score >12
5. Histological presence of cirrhosis.
6. Total bilirubin >1.5 mg/dL at Screening (subjects with Gilbert?s syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated bilirubin is <1.5× ULN).
7. AST or ALT >/= to 10× ULN, international normalized ratio (INR) >1.3, or serum creatinine ?1.5 mg/dL at Screening.
8. Creatine phosphokinase >5x ULN at screening
9. Platelet count <100,000/mm3 at Screening.
10. LDL ?190 mg/dL and already on a stable dose statin therapy at Screening for >/= 30 days
11. Inability to safely undergo a liver biopsy.
12. History of biliary diversion.
13. Known positivity for human immunodeficiency virus infection.
14. Subjects with recent history (within 1 year of Day 1) of significant atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, or acute coronary syndrome cerebrovascular accident [stroke], cerebrovascular ischemia, or transient ischemic attack or peripheral vascular disease requiring intervention). Such subjects may be identified by different means, including but not limited to, an abnormal ECG, a history or planned cardiovascular intervention such as coronary revascularization (eg, percutaneous coronary intervention or coronary artery bypass graft), coronary angioplasty, stenting, carotid atherectomy, or placement of a cardiac pacemaker or defibrillator.
a. Controlled hypertension without other recent manifestations of significant atherosclerotic cardiovascular disease and placement of cardiac pacemaker or defibrillator for reasons other than atherosclerotic cardiovascular disease (eg, for treatment of atrial fibrillation subsequent to nodal ablation) is not exclusionary.
15. Other medical conditions that may diminish life expectancy to <2 years, including known cancers (except carcinomas in situ or other stable, relatively benign carcinomas).
16. Known substance abuse in the year before Screening.
17. Pregnancy, planned pregnancy, potential for pregnancy (ie, unwillingness to use effective birth control during the study), or current or planned breast feeding.
18. Participated in a clinical research study with any investigational product being evaluated for the treatment of diabetes, weight loss, or NASH in the 6 months before Day 1.
19. Received any invest
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