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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.

NCT ID: NCT02970942

Last Updated: 2021-11-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-03-19

Brief Summary

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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

Detailed Description

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Conditions

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Hepatobiliary Disorders Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Semaglutide 0,1 mg

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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)

Semaglutide 0,2 mg

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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)

Semaglutide 0,4 mg

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily administration subcutaneously ( s.c., under the skin)

Placebo 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily administration subcutaneously ( s.c., under the skin)

Placebo 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily administration subcutaneously ( s.c., under the skin)

Interventions

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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)

Intervention Type DRUG

Placebo

Once daily administration subcutaneously ( s.c., under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

- 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Tucson, Arizona, United States

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Coronado, California, United States

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Costa Mesa, California, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Panorama City, California, United States

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Rialto, California, United States

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Boca Raton, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Lakewood Rch, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocoee, Florida, United States

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Sarasota, Florida, United States

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Monroe, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Manhasset, New York, United States

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Danville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Hermitage, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Rollingwood, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Camperdown, New South Wales, Australia

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Kingswood, New South Wales, Australia

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Westmead, New South Wales, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Graz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Aarhus N, , Denmark

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Hvidovre, , Denmark

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Helsinki, , Finland

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Besançon, , France

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Clermont-Ferrand, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Toulouse, , France

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Vénissieux, , France

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Athens, , Greece

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Athens, , Greece

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Goudi, Athens, , Greece

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Larissa, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Asahikawa-shi, Hokkaido, , Japan

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Fukui-shi, Fukui, , Japan

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Kamigyo-ku, Kyoto, , Japan

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Kumamoto-shi, Kumamoto, , Japan

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Nagakute-shi, Aichi, , Japan

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Nara-shi, Nara, , Japan

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Nishinomiya-shi, Hyogo, , Japan

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Osaka-shi, Osaka, , Japan

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Otsu-shi, Shiga, , Japan

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Saga-shi, Saga, , Japan

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Shimonoseki-shi, Yamaguchi, , Japan

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Suita-shi, Osaka, , Japan

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Suita-shi, Osaka, , Japan

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Takamatsu-shi, Kagawa, , Japan

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Toyoake-shi, Aichi, , Japan

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Alkmaar, , Netherlands

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Amstelveen, , Netherlands

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Amsterdam, , Netherlands

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Delft, , Netherlands

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Groningen, , Netherlands

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Leiden, , Netherlands

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Maastricht, , Netherlands

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Nijmegen, , Netherlands

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San Juan, , Puerto Rico

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Barnaul, , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Stavropol, , Russia

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Stavropol, , Russia

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Tomsk, , Russia

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Ulyanovsk, , Russia

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Yoshkar-Ola, , Russia

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Madrid, , Spain

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Majadahonda, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Birmingham, , United Kingdom

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Birmingham, , United Kingdom

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Bolton, , United Kingdom

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Cambridge, , United Kingdom

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Derby, , United Kingdom

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Dundee, , United Kingdom

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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Hull, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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Portsmouth, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Australia Austria Belgium Bulgaria Canada Denmark Finland France Greece Japan Netherlands Puerto Rico Russia Spain Sweden United Kingdom

References

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Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.

Reference Type RESULT
PMID: 33185364 (View on PubMed)

Nitze LM, Ratziu V, Sanyal AJ, Wong VW, Balendran C, Fleckner J, Skalshoi Kjaer M, Krarup N, Anstee QM. Exploration of Multiple Non-Invasive Tests for Assessing Response to Treatment in a Semaglutide Phase 2b Trial in Patients With MASH. Aliment Pharmacol Ther. 2025 Sep 23. doi: 10.1111/apt.70376. Online ahead of print.

Reference Type DERIVED
PMID: 40985232 (View on PubMed)

Schattenberg JM, Gronbaek H, Kliers I, Ladelund S, Long MT, Nygard SB, Sanyal AJ, Davies MJ. Proteomic signatures reflect effects of semaglutide treatment for MASH. JHEP Rep. 2025 Jul 22;7(10):101521. doi: 10.1016/j.jhepr.2025.101521. eCollection 2025 Oct.

Reference Type DERIVED
PMID: 40980163 (View on PubMed)

Ratziu V, Francque S, Behling CA, Cejvanovic V, Cortez-Pinto H, Iyer JS, Krarup N, Le Q, Sejling AS, Tiniakos D, Harrison SA. Artificial intelligence scoring of liver biopsies in a phase II trial of semaglutide in nonalcoholic steatohepatitis. Hepatology. 2024 Jul 1;80(1):173-185. doi: 10.1097/HEP.0000000000000723. Epub 2023 Dec 19.

Reference Type DERIVED
PMID: 38112484 (View on PubMed)

Wai-Sun Wong V, Anstee QM, Nitze LM, Geerts A, George J, Nolasco V, Kjaer MS, Ladelund S, Newsome PN, Ratziu V. FibroScan-aspartate aminotransferase (FAST) score for monitoring histological improvement in non-alcoholic steatohepatitis activity during semaglutide treatment: post-hoc analysis of a randomised, double-blind, placebo-controlled, phase 2b trial. EClinicalMedicine. 2023 Nov 20;66:102310. doi: 10.1016/j.eclinm.2023.102310. eCollection 2023 Dec.

Reference Type DERIVED
PMID: 38058795 (View on PubMed)

Romero-Gomez M, Armstrong MJ, Funuyet-Salas J, Mangla KK, Ladelund S, Sejling AS, Shrestha I, Sanyal AJ. Improved health-related quality of life with semaglutide in people with non-alcoholic steatohepatitis: A randomised trial. Aliment Pharmacol Ther. 2023 Aug;58(4):395-403. doi: 10.1111/apt.17598. Epub 2023 Jun 16.

Reference Type DERIVED
PMID: 37328931 (View on PubMed)

Harrison SA, Calanna S, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal A, Sejling AS, Newsome PN. Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. Contemp Clin Trials. 2020 Oct;97:106174. doi: 10.1016/j.cct.2020.106174. Epub 2020 Oct 8.

Reference Type DERIVED
PMID: 33039693 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-000685-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1179-7464

Identifier Type: OTHER

Identifier Source: secondary_id

NN9931-4296

Identifier Type: -

Identifier Source: org_study_id