Clinical trial NCT02970942: Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatobiliary Disorders
Non-alcoholic Steatohepatitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-11-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
timeFrame: After 72 weeks
Secondary outcomes:
measure: Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
timeFrame: After 72 weeks
measure: Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Steatosis
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Lobular Inflammation
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Hepatocyte Ballooning
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
timeFrame: Baseline (week 0), Week 72
measure: Change in Fibrosis-4 Score
timeFrame: Baseline (week 0), Week 72
measure: Change in NAFLD Fibrosis Score (NFS)
timeFrame: Baseline (week 0), Week 72
measure: Change in Alanine Aminotransferase (ALT)
timeFrame: Baseline (week 0), Week 72
measure: Change in Aspartate Aminotransferase (AST)
timeFrame: Baseline (week 0), Week 72
measure: Change in Gamma Glutamyl Transferase (GGT)
timeFrame: Baseline (week 0), Week 72
measure: Change in Albumin
timeFrame: Baseline (week 0), Week 72
measure: Change in International Normalized Ratio (INR)
timeFrame: Baseline (week 0), Week 72
measure: Change in Enhanced Liver Fibrosis (ELF)
timeFrame: Baseline (week 0), Week 72
measure: Change in Cytokeratin 18 (CK-18) Fragments
timeFrame: Baseline (week 0), Week 72
measure: Change in microRNA 122 (miR-122)
timeFrame: Baseline (week 0), Week 72
measure: Change in Interleukin-1 Receptor (IL-1R) Antagonist
timeFrame: Baseline (week 0), Week 72
measure: Change in Monocyte Chemoattractant Protein 1 (MCP-1)
timeFrame: Baseline (week 0), Week 72
measure: Change in Fibroblast Growth Factor 21 (FGF-21)
timeFrame: Baseline (week 0), Week 72
measure: Change in Liver Stiffness Assessed by FibroScan®
timeFrame: Baseline (week 0), Week 72
measure: Change in Liver Steatosis Assessed by FibroScan®
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)
timeFrame: Week 72
measure: Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)
timeFrame: Week 72
measure: Change in Body Weight
timeFrame: Baseline (week 0), Week 72
measure: Change in Waist Circumference
timeFrame: Baseline (week 0), Week 72
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline (week 0), Week 72
measure: Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
timeFrame: Baseline (week 0), Week 72
measure: Change in HbA1c (Millimoles Per Mole)
timeFrame: Baseline (week 0), Week 72
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (week 0), Week 72
measure: Change in Fasting Glucagon
timeFrame: Baseline (week 0), Week 72
measure: Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
timeFrame: Baseline (week 0), Week 72
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: Baseline (week 0), Week 72
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: Baseline (week 0), Week 72
measure: Change in Total Cholesterol
timeFrame: Baseline (week 0), Week 72
measure: Change in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Baseline (week 0), Week 72
measure: Change in High Density Lipoprotein (HDL) Cholesterol
timeFrame: Baseline (week 0), Week 72
measure: Change in Very Low Density Lipoprotein (VLDL) Cholesterol
timeFrame: Baseline (week 0), Week 72
measure: Change in Triglycerides
timeFrame: Baseline (week 0), Week 72
measure: Change in Free Fatty Acids
timeFrame: Baseline (week 0), Week 72
measure: Change in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: Baseline (week 0), Week 72
measure: Change in Short Form 36 (SF-36) Score
timeFrame: Baseline (week 0), Week 72
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From week 0 to week 79
measure: Number of Treatment-emergent Hypoglycaemic Episodes
timeFrame: From week 0 to week 79
measure: Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: From week 0 to week 79
measure: Number of Treatment-emergent Severe Hypoglycaemic Episodes
timeFrame: From week 0 to week 79
measure: Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
timeFrame: From week 0 to week 79
measure: Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
timeFrame: From week 0 to week 79
measure: Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
timeFrame: From week 0 to week 79
measure: Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
timeFrame: From week 0 to week 79
measure: Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
timeFrame: From week 0 to week 79
measure: Change in Pulse From Baseline to Week 72
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Electrocardiogram (ECG)
timeFrame: Baseline (week 0), Week 72
measure: Percentage of Participants With Change in Physical Examination: Cardiovascular System
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: General Appearance
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Musculoskeletal System
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Respiratory System
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Skin
timeFrame: Week -6, week 72
measure: Percentage of Participants With Change in Physical Examination: Thyroid Gland
timeFrame: Week -6, week 72
measure: Change in Haematocrit
timeFrame: Baseline (week 0), Week 72
measure: Change in Haemoglobin (g/dL)
timeFrame: Baseline (week 0), Week 72
measure: Change in Haemoglobin (mmol/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Leukocytes
timeFrame: Baseline (week 0), Week 72
measure: Change in Thrombocytes
timeFrame: Baseline (week 0), Week 72
measure: Change in Erythrocytes
timeFrame: Baseline (week 0), Week 72
measure: Change in Creatinine (mg/dL)
timeFrame: Baseline (week 0), Week 72
measure: Change in Creatinine (Umol/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline (week 0), Week 72
measure: Change in Creatine Kinase
timeFrame: Baseline (week 0), Week 72
measure: Change in Urea
timeFrame: Baseline (week 0), Week 72
measure: Change in Total Bilirubin (mg/dL)
timeFrame: Baseline (week 0), Week 72
measure: Change in Total Bilirubin (Umol/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Alkaline Phosphatase
timeFrame: Baseline (week 0), Week 72
measure: Change in Ferritin
timeFrame: Baseline (week 0), Week 72
measure: Change in Sodium (mEq/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Sodium (mmol/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Potassium (mEq/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Potassium (mmol/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Calcium (mg/dL)
timeFrame: Baseline (week 0), Week 72
measure: Change in Calcium (mmol/L)
timeFrame: Baseline (week 0), Week 72
measure: Change in Amylase
timeFrame: Baseline (week 0), Week 72
measure: Change in Lipase
timeFrame: Baseline (week 0), Week 72
measure: Change in Calcitonin
timeFrame: Baseline (week 0), Week 72
Other outcomes:
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state: Florida
city: Ocoee
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country: Bulgaria
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city: Sofia
country: Bulgaria
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country: Canada
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state: Alberta
city: Winnipeg
country: Canada
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state: Manitoba
city: Halifax
country: Canada
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state: Nova Scotia
city: Brampton
country: Canada
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state: Ontario
city: Hamilton
country: Canada
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city: London
country: Canada
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state: Ontario
city: Toronto
country: Canada
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city: NICE cedex 3
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city: Pessac
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city: Toulouse
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city: Venissieux
country: France
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city: Athens
country: Greece
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city: Athens
country: Greece
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city: Goudi, Athens
country: Greece
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city: Larissa
country: Greece
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city: Thessaloniki
country: Greece
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city: Thessaloniki
country: Greece
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city: Asahikawa-shi, Hokkaido
country: Japan
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city: Fukui-shi, Fukui
country: Japan
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city: Kamigyo-ku, Kyoto
country: Japan
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city: Kumamoto-shi, Kumamoto
country: Japan
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city: Nagakute-shi, Aichi
country: Japan
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city: Nara-shi, Nara
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city: Nishinomiya-shi, Hyogo
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city: Osaka-shi, Osaka
country: Japan
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city: Saga-shi, Saga
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city: Shimonoseki-shi, Yamaguchi
country: Japan
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city: Suita-shi, Osaka
country: Japan
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city: Suita-shi, Osaka
country: Japan
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city: Takamatsu-shi, Kagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Toyoake-shi, Aichi
country: Japan
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city: Alkmaar
country: Netherlands
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city: Amstelveen
country: Netherlands
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city: Amsterdam
country: Netherlands
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city: Delft
country: Netherlands
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country: Russian Federation
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city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Penza
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
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city: Stavropol
country: Russian Federation
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city: Stavropol
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Spain
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city: Majadahonda
country: Spain
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city: Santander
country: Spain
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city: Santiago de Compostela
country: Spain
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country: Spain
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city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
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city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bolton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
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city: Derby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Portsmouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: 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.
citation: 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.