Effects of Exenatide (Byetta®) on Liver Function in Patients With Nonalcoholic Steatohepatitis (NASH)

NCT01208649 | Completed Phase 4

• 1 other identifier: H80-MC-O008
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to test the hypothesis that 24 weeks of treatment with exenatide will improve the histological acitvity of NASH (steatosis,necroinflammation, ballooning), summarized in the recently introduced NASH-score in patients with normal, impaired or diabetic glucose tolerance compared to dietary guidance alone.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

exenatide; hepatic steatosis; insulin resistance; insulin sensitizers; nonalcoholic fatty liver disease; - GLP1-Analog

Outcome Measures

Primary Outcomes (1)

• histological activity of NASH (steatosis, necroinflammation, ballooning)

  24 weeks

Secondary Outcomes (1)

• Liver fibrosis, as determined using the fibrosis score

  24 weeks

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

Drug (including placebo)

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

Drug: Exenatide

Interventions

Exenatide DRUG

Exenatide; 48 weeks 10 microg injection s.c., twice daily, before the morning and evening meal with a four week wash-in phase with 5 microg injection s.c.twice daily

Exenatide; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years, inclusive.
• Patients present with histologically proven non-alcoholic steatohepatitis ascertained by the single center pathologist between visit 1 and 2
• First liver biopsy was obtained not later than 6 months before visit 1
• Patients have HbA1c not exceeding 10.0%.
• Patients have a history of stable body weight (not varying by \>10% for at least 3 months prior to screening

You may not qualify if:

• 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.
• 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%).
• Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
• Patients with evidence of viral or autoimmune hepatitis (positive testing for HBsAG, anti-HCV or anti-HIV, pos. AMA-screen, ANA-titer \> 1:160)
• Patients with inherited liver diseases (e.g. Wilson's disease, Hemochromatosis)
• Patients have alcohol consumption (\>20 g daily for males and \>10 g daily for females)
• Patients have decompensated liver cirrhosis (Child-Pugh score \>7)
• Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range.
• Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening.
• Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
• Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria.
• Patients have a known allergy or hypersensitivity to exenatide, or excipients contained in these agents.
• Patients have or had concomitant medication with thiazolidinediones.
• 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.
• Patients have known hemoglobinopathy or chronic anemia

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Department of Medicine I; University Hospital St. Josef-Hospital

Bochum, 44791, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Insulin Resistance

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Wolfgang E. Schmidt, Prof. Dr.

  Ruhr-University Bochum

  STUDY DIRECTOR

• Wolfgang E. Schmidt, Prof. Dr.

  Ruhr-University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

DE (1)