Non alcoholic steatohepatitis (NASH) MedDRA version: 9.1 Level: LLT Classification code 10053219 Term: Non-alcoholic steatohepatitis
Conditions
Interventions
Trade Name: Byetta
Product Name: Exenatide
Product Code: LY2148568
Pharmaceutical Form: Solution for injection
CAS Number: 141758749
Other descriptive name: EXENATIDE
Concentration unit: µg microgram(
Sponsors
Department of Medicine I, University Hospital St. Josef-Hospital, Ruhr University Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 75 years, inclusive. (2) Patients present with histologically proven non-alcoholic steatohepatitis ascertained by the single center pathologist between visit 1 and 2 (3) First liver biopsy was obtained not later than 6 months before visit 1 (4) Patients have HbA1c not exceeding 10.0%. (5) Patients have a history of stable body weight (not varying by >10% for at least 3 months prior to screening). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. (2) Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner.). A male subject who is sexually active and has not been surgically sterilised must be informed that he must either use a condom during intercourse, ensure that his partner practices contraception, or he must refrain from sexual intercourse during the trial and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication. It is strongly recommended that the female partners use a highly effective contraception (Pearl Index 1:160) (5) Patients with inherited liver diseases (e.g. Wilson’s disease, Hemochromatosis) (6) Patients have alcohol consumption (>20 g daily for males and >10 g daily for females) (7) Patients have decompensated liver cirrhosis (Child-Pugh score ?7) (8) Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range. (9) Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening. (10) Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer. (11) Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. (12) Patients have a known allergy or hypersensitivity to exenatide, or excipients contained in these agents. (13) Patients have or had concomitant medication with thiazolidinediones. (14) Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >1.8 mg/dL for males and greater than or equal to >1.5 mg/dL for females. (15) Patients have known hemoglobinopathy or chronic anemia (16) Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. (17) Patients have used any prescription drug to promote weight loss within 3 months prior to screening. (18) Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. (19) Patients fail to satisfy the investigator of suitability to participate for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that 24 weeks of treatment with exenatide will improve the histological activity of NASH (steatosis, necroinflammation, ballooning), summarized in the recently introduced NASH-Score (appendix 1) in patients with normal, impaired or diabetic glucose tolerance compared to dietary guidance alone.;Secondary Objective: The secondary objectives are to investigate the effects of exenatide on: •Enzyme activities of AST, ALT, GGT •Liver fibrosis, as determined using the fibrosis score (appendix 3) •Plasma levels of triglycerides, free fatty acids, cholesterol (total, HDL, LDL) •Plasma levels of adiponectin •Insulin sensitivity •Hepatic mitochondrial function assessed by non-invasive 13C-methionine breath test •Body weight and fat distribution •Hepatic fat content, as measured by magnetic resonance tomography ;Primary end point(s): The primary end point of this study will be the absolute change in the NASH activity score in a liver biopsy obtained 24 weeks after exenatide or placebo treatment. | — |
Countries
Germany
Outcome results
None listed