Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002324-32 | EudraCT Number |
Not provided
Not provided
The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.
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Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. The study duration from first dose of study medication was 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: combination therapy | Experimental | Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally |
|
| Arm B: tropifexor monotherapy | Experimental | Tropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally |
|
| Arm C: licogliflozin monotherapy | Experimental | Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally |
|
| Arm D: Placebo | Placebo Comparator | Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tropifexor | Drug | 100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day |
| Measure | Description | Time Frame |
|---|---|---|
| Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Response was defined as at least a one-stage improvement in fibrosis without worsening of nonalcoholic steatohepatitis (NASH) Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | Baseline, Week 48 |
| Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. |
Not provided
Inclusion Criteria:
Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:
Exclusion Criteria:
Type 1 diabetes mellitus
Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening
HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas
Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gut PC Digestive Health Specialist | Dothan | Alabama | 36305 | United States | ||
| Southern California Research Center |
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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One of the randomized participants in the tropifexor group was not treated due to loss of interest in the study.
234 participants were randomized at 81 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tropifexor Monotherapy | Tropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally |
| FG001 | Licogliflozin Monotherapy | Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2021 | Oct 26, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Licogliflozin | Drug | 30mg tablet of licoglifozin taken orally every day |
|
|
| Placebo | Other | licogliflozin placebo + tropifexor placebo |
|
| 48 weeks |
| Number and Percentage of Participants With at Least One Stage Improvement in Fibrosis | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | 48 weeks |
| Number and Percentage of Participants With at Least Two Stage Improvement in Fibrosis Without Worsening of NASH | Fibrosis staging and Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | 48 weeks |
| Number and Percentage of Participants Achieving 5% or More Reduction in Body Weight at Week 48 Compared With Baseline | Whether the participants had 5% or more reduction in body weight. | Baseline, Week 48 |
| Change From Baseline to Week 48 in Percent Liver Fat Content Based on Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF) | Change in liver fat content based on MRI-PDFF. | Baseline, Week 48 |
| Change From Baseline in Alanine Transaminase (ALT) Over Time | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) |
| Change From Baseline in Aspartate Aminotransferase (AST) Over Time | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) |
| Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) |
| Coronado |
| California |
| 92118 |
| United States |
| Velocity Clinical Trials | Los Angeles | California | 90057 | United States |
| California Liver Research Institute | Pasadena | California | 91105 | United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| San fernando Valley Health Institute | Van Nuys | California | 91405 | United States |
| Island View Gastroenterology Associates | Ventura | California | 93003 | United States |
| Integrity Clinical Rsh LLC | Doral | Florida | 33166 | United States |
| Galenus Group | Lehigh Acres | Florida | 33936 | United States |
| Genoma Research Group Inc | Miami | Florida | 33165-7574 | United States |
| Digestive Res Alliance of Michiana | South Bend | Indiana | 46635 | United States |
| Southern Therapy and Adv Res LLC | Jackson | Mississippi | 39216 | United States |
| Clinical Research Professionals Inc | Chesterfield | Missouri | 63005 | United States |
| Southwest Gastroenterology Associates | Albuquerque | New Mexico | 87109 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Clinical Trials Of America LLC | Lenoir | North Carolina | 28645 | United States |
| Diabetes And Endocrinology Conslt | Morehead City | North Carolina | 28557 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| Digestive Disease Research | Greenwood | South Carolina | 29646 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Summit Medical Care | Hermitage | Tennessee | 37076 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |
| Pioneer Research Solutions | Sugar Land | Texas | 77479 | United States |
| Novartis Investigative Site | San Juan Bautista | Buenos Aires | C1073ABA | Argentina |
| Novartis Investigative Site | Mechelen | 2800 | Belgium |
| Novartis Investigative Site | Salvador | Estado de Bahia | 40110-160 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04037-002 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05403-000 | Brazil |
| Novartis Investigative Site | Sofia | 1413 | Bulgaria |
| Novartis Investigative Site | Sofia | 1784 | Bulgaria |
| Novartis Investigative Site | Montreal | Quebec | H4A 3J1 | Canada |
| Novartis Investigative Site | Valdivia | Los Ríos Region | 5110683 | Chile |
| Novartis Investigative Site | Viña del Mar | Valparaiso | 2540364 | Chile |
| Novartis Investigative Site | Medellín | Antioquia | 050001 | Colombia |
| Novartis Investigative Site | Rionegro | Antioquia | 054047 | Colombia |
| Novartis Investigative Site | Bogotá | 110131 | Colombia |
| Novartis Investigative Site | Aarhus N | 8200 | Denmark |
| Novartis Investigative Site | Tallinn | 10617 | Estonia |
| Novartis Investigative Site | Berlin | 10825 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | New Delhi | National Capital Territory of Delhi | 110070 | India |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Palermo | PA | 90127 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760 8557 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Novartis Investigative Site | Saga | Saga-ken | 849-8501 | Japan |
| Novartis Investigative Site | Izumo | Shimane | 693 8501 | Japan |
| Novartis Investigative Site | Guadalajara | Jalisco | 44130 | Mexico |
| Novartis Investigative Site | Cuauhtémoc | Mexico City | 06700 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64460 | Mexico |
| Novartis Investigative Site | México | 22381 | Mexico |
| FDI Clinical Research | San Juan | 00927 | Puerto Rico |
| Novartis Investigative Site | Novosibirsk | 630090 | Russia |
| Novartis Investigative Site | Saint Petersburg | 199034 | Russia |
| Novartis Investigative Site | Saint Petersburg | 199226 | Russia |
| Novartis Investigative Site | Samara | 443063 | Russia |
| Novartis Investigative Site | Singapore | 119074 | Singapore |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Novartis Investigative Site | Cape Town | 7531 | South Africa |
| Novartis Investigative Site | Dongjak Gu | Seoul | 07061 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | Kaohsiung City | 80756 | Taiwan |
| Novartis Investigative Site | Tainan | 70403 | Taiwan |
| Novartis Investigative Site | Istanbul | Topkapi | 34010 | Turkey (Türkiye) |
| Novartis Investigative Site | Aberdeen | Grampian Region | AB25 2ZN | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| FG002 | Combination Therapy | Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally |
| FG003 | Placebo | Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization and were treated
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tropifexor Monotherapy | Tropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally |
| BG001 | Licogliflozin Monotherapy | Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally |
| BG002 | Combination Therapy | Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally |
| BG003 | Placebo | Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Response was defined as at least a one-stage improvement in fibrosis without worsening of nonalcoholic steatohepatitis (NASH) Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | Full Analysis Set (FAS): all participants to whom study treatment has been assigned by randomization and had an assessment of response at Week 48. Efficacy analysis was conducted using the FAS. | Posted | Count of Participants | Participants | Baseline, Week 48 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | Full Analysis Set (FAS): all participants to whom study treatment has been assigned by randomization. Efficacy analysis was conducted using the FAS | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | FAS | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants With at Least One Stage Improvement in Fibrosis | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | FAS | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants With at Least Two Stage Improvement in Fibrosis Without Worsening of NASH | Fibrosis staging and Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. | FAS | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants Achieving 5% or More Reduction in Body Weight at Week 48 Compared With Baseline | Whether the participants had 5% or more reduction in body weight. | Data are reported for the total number of participants in the treatment group with response variable defined. | Posted | Count of Participants | Participants | Baseline, Week 48 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in Percent Liver Fat Content Based on Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF) | Change in liver fat content based on MRI-PDFF. | FAS: all participants to whom study treatment has been assigned by randomization and had an assessment at Week 48. This analysis was performed in 40% of participants. | Posted | Mean | Standard Deviation | Percent liver fat | Baseline, Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Alanine Transaminase (ALT) Over Time | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. | The safety analysis set included all participants who received at least one dose of study treatment. At each time point, only participants with a value at both Baseline and that time point were included. | Posted | Mean | Standard Deviation | units per liter (U/L) | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) Over Time | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. | The safety analysis set included all participants who received at least one dose of study treatment. At each time point, only participants with a value at both Baseline and that time point were included. | Posted | Mean | Standard Deviation | U/L | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. | The safety analysis set included all participants who received at least one dose of study treatment. At each time point, only participants with a value at both Baseline and that time point were included. | Posted | Mean | Standard Deviation | U/L | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) |
|
Up to approximately 52 weeks
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, that ocurred during treatment period. They include events that started after the first dose of study treatment or events that were present prior to start of study treatment but increased in severity during on-treatment period. The safety analysis set included all participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LJN452 | Tropifexor monotherapy arm: tropifexor 140 mcgcapsule (+ placebo matching licogliflozin tablet), once daily orally | 0 | 53 | 4 | 53 | 35 | 53 |
| EG001 | LIK066 | Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally | 0 | 55 | 3 | 55 | 39 | 55 |
| EG002 | Combination | Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally | 0 | 84 | 4 | 84 | 54 | 84 |
| EG003 | Placebo | Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily | 0 | 41 | 3 | 41 | 23 | 41 |
| EG004 | All Patients | All Patients | 0 | 233 | 14 | 233 | 151 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | (862) 778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2019 | Oct 26, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630573 | tropifexor |
| C000709456 | licogliflozin |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Unknown |
|
| OG003 | Placebo | Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
|
|
| OG003 |
| Placebo |
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
|
|
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
|
|
| Placebo |
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
|
|
|
|
|
|
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily
|
|
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily
|
|
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily
|
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