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



Status:Active, not recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/31/2019
Start Date:November 30, 2016
End Date:April 2, 2020

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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

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


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)
We found this trial at
36
sites
Richmond, Virginia 23219
2350
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Richmond, VA
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Austin, Texas 78731
1770
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Austin, TX
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Baltimore, Maryland 21229
2325
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Baltimore, MD
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Birmingham, Alabama 35215
2077
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Birmingham, AL
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Boca Raton, Florida 33433
2708
mi
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Boca Raton, FL
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Burlington, Vermont 05401
2326
mi
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Burlington, VT
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Camperdown, New South Wales
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Camperdown,
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Chandler, Arizona 85224
1128
mi
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Chandler, AZ
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Coronado, California 92118
1067
mi
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Coronado, CA
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Costa Mesa, California 92627
993
mi
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Costa Mesa, CA
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Dallas, Texas 75231
1677
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Dallas, TX
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Danville, Pennsylvania 17822
2273
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from 98109
Danville, PA
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Detroit, Michigan 48201
1933
mi
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Detroit, MI
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Gainesville, Florida 32608
2453
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Gainesville, FL
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Glendale, Arizona 85306
1103
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Glendale, AZ
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Hermitage, Tennessee 37076
?
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Hermitage, TN
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Houston, Texas 77030
1892
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Houston, TX
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Jacksonville, Florida 32207
2454
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Jacksonville, FL
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La Mesa, California 91942
1064
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La Mesa, CA
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Lakewood Ranch, Florida 34211
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Lakewood Ranch, FL
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Las Vegas, Nevada 89128
868
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Las Vegas, NV
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Los Angeles, California 90027
956
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Los Angeles, CA
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Manhasset, New York 11030
2413
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Manhasset, NY
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Miami, Florida 33136
2730
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Miami, FL
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Monroe, Louisiana 71203
1890
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Monroe, LA
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Northridge, California 91325
946
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Northridge, CA
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Ocoee, Florida 34761
2538
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Ocoee, FL
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Omaha, Nebraska 68114
1367
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Omaha, NE
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Panorama City, California 91402
948
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Panorama City, CA
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Pittsburgh, Pennsylvania 15224
2132
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Pittsburgh, PA
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Rialto, California 92376
969
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Rialto, CA
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Rochester, Minnesota 55905
1450
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Rochester, MN
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Rollingwood, Texas 78746
?
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Rollingwood, TX
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San Antonio, Texas 78224
1787
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San Antonio, TX
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Seattle, Washington 98105
2
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Seattle, WA
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Tucson, Arizona 85704
1212
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Tucson, AZ
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