Clinical Trial Details

Trial ID: L0228
Source ID: NCT02970942
Associated Drug: Semaglutide
Title: Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT02970942/results
Conditions: Hepatobiliary Disorders|Non-alcoholic Steatohepatitis
Interventions: Drug: Semaglutide|Drug: Placebo
Outcome Measures: Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)|Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)|Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)|Percentage of Participants With Change in Steatosis|Percentage of Participants With Change in Lobular Inflammation|Percentage of Participants With Change in Hepatocyte Ballooning|Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification|Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score|Change in Fibrosis-4 Score|Change in NAFLD Fibrosis Score (NFS)|Change in Alanine Aminotransferase (ALT)|Change in Aspartate Aminotransferase (AST)|Change in Gamma Glutamyl Transferase (GGT)|Change in Albumin|Change in International Normalized Ratio (INR)|Change in Enhanced Liver Fibrosis (ELF)|Change in Cytokeratin 18 (CK-18) Fragments|Change in microRNA 122 (miR-122)|Change in Interleukin-1 Receptor (IL-1R) Antagonist|Change in Monocyte Chemoattractant Protein 1 (MCP-1)|Change in Fibroblast Growth Factor 21 (FGF-21)|Change in Liver Stiffness Assessed by FibroScan??|Change in Liver Steatosis Assessed by FibroScan??|Percentage of Participants With Weight Loss of ??? 5% of Baseline Body Weight at 72 Weeks (Yes/No)|Percentage of Participants With Weight Loss of ??? 10% of Baseline Body Weight at 72 Weeks (Yes/No)|Change in Body Weight|Change in Waist Circumference|Change in Body Mass Index (BMI)|Change in Glycosylated Haemoglobin (HbA1c) (%-Point)|Change in HbA1c (Millimoles Per Mole)|Change in Fasting Plasma Glucose (FPG)|Change in Fasting Glucagon|Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)|Change in Diastolic Blood Pressure (DBP)|Change in Systolic Blood Pressure (SBP)|Change in Total Cholesterol|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in High Density Lipoprotein (HDL) Cholesterol|Change in Very Low Density Lipoprotein (VLDL) Cholesterol|Change in Triglycerides|Change in Free Fatty Acids|Change in High Sensitivity C-reactive Protein (hsCRP)|Change in Short Form 36 (SF-36) Score|Number of Treatment-emergent Adverse Events (TEAEs)|Number of Treatment-emergent Hypoglycaemic Episodes|Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes|Number of Treatment-emergent Severe Hypoglycaemic Episodes|Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events|Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)|Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)|Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)|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)|Change in Pulse From Baseline to Week 72|Percentage of Participants With Change in Electrocardiogram (ECG)|Percentage of Participants With Change in Physical Examination: Cardiovascular System|Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System|Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth|Percentage of Participants With Change in Physical Examination: General Appearance|Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck|Percentage of Participants With Change in Physical Examination: Lymph Node Palpation|Percentage of Participants With Change in Physical Examination: Musculoskeletal System|Percentage of Participants With Change in Physical Examination: Respiratory System|Percentage of Participants With Change in Physical Examination: Skin|Percentage of Participants With Change in Physical Examination: Thyroid Gland|Change in Haematocrit|Change in Haemoglobin (g/dL)|Change in Haemoglobin (mmol/L)|Change in Leukocytes|Change in Thrombocytes|Change in Erythrocytes|Change in Creatinine (mg/dL)|Change in Creatinine (Umol/L)|Change in Estimated Glomerular Filtration Rate (eGFR)|Change in Creatine Kinase|Change in Urea|Change in Total Bilirubin (mg/dL)|Change in Total Bilirubin (Umol/L)|Change in Alkaline Phosphatase|Change in Ferritin|Change in Sodium (mEq/L)|Change in Sodium (mmol/L)|Change in Potassium (mEq/L)|Change in Potassium (mmol/L)|Change in Calcium (mg/dL)|Change in Calcium (mmol/L)|Change in Amylase|Change in Lipase|Change in Calcitonin
Sponsor/Collaborators: Novo Nordisk A/S
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 320
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: November 30, 2016
Completion Date: March 19, 2020
Results First Posted: April 21, 2021
Last Update Posted: November 16, 2021
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, United States|Novo Nordisk Investigational Site, Chandler, Arizona, United States|Novo Nordisk Investigational Site, Tucson, Arizona, United States|Novo Nordisk Investigational Site, Coronado, California, United States|Novo Nordisk Investigational Site, Costa Mesa, California, United States|Novo Nordisk Investigational Site, La Mesa, California, United States|Novo Nordisk Investigational Site, Los Angeles, California, United States|Novo Nordisk Investigational Site, Northridge, California, United States|Novo Nordisk Investigational Site, Panorama City, California, United States|Novo Nordisk Investigational Site, Rialto, California, United States|Novo Nordisk Investigational Site, Boca Raton, Florida, United States|Novo Nordisk Investigational Site, Gainesville, Florida, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, United States|Novo Nordisk Investigational Site, Lakewood Ranch, Florida, United States|Novo Nordisk Investigational Site, Miami, Florida, United States|Novo Nordisk Investigational Site, Miami, Florida, United States|Novo Nordisk Investigational Site, Ocoee, Florida, United States|Novo Nordisk Investigational Site, Sarasota, Florida, United States|Novo Nordisk Investigational Site, Monroe, Louisiana, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, United States|Novo Nordisk Investigational Site, Detroit, Michigan, United States|Novo Nordisk Investigational Site, Rochester, Minnesota, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, United States|Novo Nordisk Investigational Site, Manhasset, New York, United States|Novo Nordisk Investigational Site, Danville, Pennsylvania, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, United States|Novo Nordisk Investigational Site, Hermitage, Tennessee, United States|Novo Nordisk Investigational Site, Austin, Texas, United States|Novo Nordisk Investigational Site, Dallas, Texas, United States|Novo Nordisk Investigational Site, Dallas, Texas, United States|Novo Nordisk Investigational Site, Houston, Texas, United States|Novo Nordisk Investigational Site, Houston, Texas, United States|Novo Nordisk Investigational Site, Rollingwood, Texas, United States|Novo Nordisk Investigational Site, San Antonio, Texas, United States|Novo Nordisk Investigational Site, Burlington, Vermont, United States|Novo Nordisk Investigational Site, Richmond, Virginia, United States|Novo Nordisk Investigational Site, Seattle, Washington, United States|Novo Nordisk Investigational Site, Camperdown, New South Wales, Australia|Novo Nordisk Investigational Site, Kingswood, New South Wales, Australia|Novo Nordisk Investigational Site, Westmead, New South Wales, Australia|Novo Nordisk Investigational Site, Box Hill, Victoria, Australia|Novo Nordisk Investigational Site, Fitzroy, Victoria, Australia|Novo Nordisk Investigational Site, Graz, Austria|Novo Nordisk Investigational Site, Salzburg, Austria|Novo Nordisk Investigational Site, Wien, Austria|Novo Nordisk Investigational Site, Bruxelles, Belgium|Novo Nordisk Investigational Site, Bruxelles, Belgium|Novo Nordisk Investigational Site, Edegem, Belgium|Novo Nordisk Investigational Site, Gent, Belgium|Novo Nordisk Investigational Site, Sofia, Bulgaria|Novo Nordisk Investigational Site, Sofia, Bulgaria|Novo Nordisk Investigational Site, Calgary, Alberta, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, Canada|Novo Nordisk Investigational Site, Halifax, Nova Scotia, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, Canada|Novo Nordisk Investigational Site, London, Ontario, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, Canada|Novo Nordisk Investigational Site, Aarhus N, Denmark|Novo Nordisk Investigational Site, Hvidovre, Denmark|Novo Nordisk Investigational Site, Helsinki, Finland|Novo Nordisk Investigational Site, Besan??on, France|Novo Nordisk Investigational Site, Clermont-Ferrand, France|Novo Nordisk Investigational Site, Lyon Cedex 4, France|Novo Nordisk Investigational Site, MARSEILLE cedex 08, France|Novo Nordisk Investigational Site, Montpellier, France|Novo Nordisk Investigational Site, NICE cedex 3, France|Novo Nordisk Investigational Site, Paris, France|Novo Nordisk Investigational Site, Paris, France|Novo Nordisk Investigational Site, Pessac, France|Novo Nordisk Investigational Site, Toulouse, France|Novo Nordisk Investigational Site, Venissieux, France|Novo Nordisk Investigational Site, Athens, Greece|Novo Nordisk Investigational Site, Athens, Greece|Novo Nordisk Investigational Site, Goudi, Athens, Greece|Novo Nordisk Investigational Site, Larissa, Greece|Novo Nordisk Investigational Site, Thessaloniki, Greece|Novo Nordisk Investigational Site, Thessaloniki, Greece|Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, Japan|Novo Nordisk Investigational Site, Fukui-shi, Fukui, Japan|Novo Nordisk Investigational Site, Kamigyo-ku, Kyoto, Japan|Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto, Japan|Novo Nordisk Investigational Site, Nagakute-shi, Aichi, Japan|Novo Nordisk Investigational Site, Nara-shi, Nara, Japan|Novo Nordisk Investigational Site, Nishinomiya-shi, Hyogo, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, Japan|Novo Nordisk Investigational Site, Otsu-shi, Shiga, Japan|Novo Nordisk Investigational Site, Saga-shi, Saga, Japan|Novo Nordisk Investigational Site, Shimonoseki-shi, Yamaguchi, Japan|Novo Nordisk Investigational Site, Suita-shi, Osaka, Japan|Novo Nordisk Investigational Site, Suita-shi, Osaka, Japan|Novo Nordisk Investigational Site, Takamatsu-shi, Kagawa, Japan|Novo Nordisk Investigational Site, Toyoake-shi, Aichi, Japan|Novo Nordisk Investigational Site, Alkmaar, Netherlands|Novo Nordisk Investigational Site, Amstelveen, Netherlands|Novo Nordisk Investigational Site, Amsterdam, Netherlands|Novo Nordisk Investigational Site, Delft, Netherlands|Novo Nordisk Investigational Site, Groningen, Netherlands|Novo Nordisk Investigational Site, Leiden, Netherlands|Novo Nordisk Investigational Site, Maastricht, Netherlands|Novo Nordisk Investigational Site, Nijmegen, Netherlands|Novo Nordisk Investigational Site, San Juan, Puerto Rico|Novo Nordisk Investigational Site, Barnaul, Russian Federation|Novo Nordisk Investigational Site, Kazan, Russian Federation|Novo Nordisk Investigational Site, Kemerovo, Russian Federation|Novo Nordisk Investigational Site, Krasnoyarsk, Russian Federation|Novo Nordisk Investigational Site, Moscow, Russian Federation|Novo Nordisk Investigational Site, Moscow, Russian Federation|Novo Nordisk Investigational Site, Moscow, Russian Federation|Novo Nordisk Investigational Site, Moscow, Russian Federation|Novo Nordisk Investigational Site, Moscow, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, Russian Federation|Novo Nordisk Investigational Site, Penza, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saratov, Russian Federation|Novo Nordisk Investigational Site, Saratov, Russian Federation|Novo Nordisk Investigational Site, Stavropol, Russian Federation|Novo Nordisk Investigational Site, Stavropol, Russian Federation|Novo Nordisk Investigational Site, Tomsk, Russian Federation|Novo Nordisk Investigational Site, Ulianovsk, Russian Federation|Novo Nordisk Investigational Site, Yoshkar-Ola, Russian Federation|Novo Nordisk Investigational Site, Madrid, Spain|Novo Nordisk Investigational Site, Majadahonda, Spain|Novo Nordisk Investigational Site, Santander, Spain|Novo Nordisk Investigational Site, Santiago de Compostela, Spain|Novo Nordisk Investigational Site, Sevilla, Spain|Novo Nordisk Investigational Site, Valencia, Spain|Novo Nordisk Investigational Site, G??teborg, Sweden|Novo Nordisk Investigational Site, Malm??, Sweden|Novo Nordisk Investigational Site, Stockholm, Sweden|Novo Nordisk Investigational Site, Stockholm, Sweden|Novo Nordisk Investigational Site, Birmingham, United Kingdom|Novo Nordisk Investigational Site, Birmingham, United Kingdom|Novo Nordisk Investigational Site, Bolton, United Kingdom|Novo Nordisk Investigational Site, Cambridge, United Kingdom|Novo Nordisk Investigational Site, Derby, United Kingdom|Novo Nordisk Investigational Site, Dundee, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, United Kingdom|Novo Nordisk Investigational Site, Glasgow, United Kingdom|Novo Nordisk Investigational Site, Hull, United Kingdom|Novo Nordisk Investigational Site, Leeds, United Kingdom|Novo Nordisk Investigational Site, London, United Kingdom|Novo Nordisk Investigational Site, London, United Kingdom|Novo Nordisk Investigational Site, London, United Kingdom|Novo Nordisk Investigational Site, Nottingham, United Kingdom|Novo Nordisk Investigational Site, Portsmouth, United Kingdom|Novo Nordisk Investigational Site, Swansea, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT02970942

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D327 Semaglutide Chemical drug DB13928 GLP1R agonist Antidiabetic drug Under clinical trials Details
D055 Calcium Chemical drug DB01373 CAST; COMP; CP; BMP4; MGP -- Under clinical trials Details
D080 Citrulline Chemical drug DB00155 -- -- Under clinical trials Details
D082 CK-18 Miscellany -- -- -- Under clinical trials Details
D083 CLA Chemical drug DB01211 KCNH2; SLCO1B1; SLCO1B3 -- Under clinical trials Details
D155 Glucagon Biological drug DB00040 GCGR agonist Antidiabetic drug Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D248 Obeticholic Acid Chemical drug DB05990 NR1H4 activator; NR1H4 agonist; FXR agonist Enhance lipid metabolism Approval rejected Details
D545 Pig placenta extract Biological extract -- -- -- Under clinical trials Details