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Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

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ClinicalTrials.gov Identifier: NCT02970942
Recruitment Status : Active, not recruiting
First Posted : November 22, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

Condition or disease Intervention/treatment Phase
Hepatobiliary Disorders Non-alcoholic Steatohepatitis Drug: Semaglutide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : November 27, 2019
Estimated Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide 0,1 mg Drug: Semaglutide
Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Experimental: Semaglutide 0,2 mg Drug: Semaglutide
Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Experimental: Semaglutide 0,4 mg Drug: Semaglutide
Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Placebo Comparator: Placebo 1 Drug: Placebo
Once daily administration subcutaneously ( s.c., under the skin)
Placebo Comparator: Placebo 2 Drug: Placebo
Once daily administration subcutaneously ( s.c., under the skin)
Placebo Comparator: Placebo 3 Drug: Placebo
Once daily administration subcutaneously ( s.c., under the skin)


Outcome Measures
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Primary Outcome Measures :
  1. NASH (non-alcoholic steatohepatitis) resolution without worsening of fibrosis [ Time Frame: After 72 weeks ]
    (yes/no)


Secondary Outcome Measures :
  1. At least one stage of liver fibrosis improvement with no worsening of NASH [ Time Frame: After 72 weeks ]
    Worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH clinical research network (CRN) criteria (yes/no)

  2. Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8) [ Time Frame: Week 0, week 72 ]
  3. Stage of fibrosis according to the Kleiner fibrosis classification (0-4) [ Time Frame: Week 0, week 72 ]
  4. Activity component of steatosis-activity-fibrosis (SAF) score (0-4) [ Time Frame: Week 0, week 72 ]
  5. Fasting plasma glucose (FPG) [ Time Frame: Week 0, week 72 ]
  6. Glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 72 ]
  7. Serum enhanced liver fibrosis (ELF) [ Time Frame: Week 0, week 72 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970942


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Sponsors and Collaborators
Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02970942     History of Changes
Other Study ID Numbers: NN9931-4296
2016-000685-39 ( EudraCT Number )
U1111-1179-7464 ( Other Identifier: WHO )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to Novo Nordisk disclosure commitment on novonordisk.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases