Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo oral capsules taken one daily for 52 weeks |
|
| Icosabutate 300mg | Experimental | Icosabutate 300mg oral capsule taken once daily for 52 weeks |
|
| Icosabutate 600mg | Experimental | Icosabutate 600mg oral capsules taken once daily for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icosabutate | Drug | Icosabutate oral capsule once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning). | 52 weeks | |
| Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central ResearchAssociates Inc. | Birmingham | Alabama | 35205 | United States | ||
| Arizona Liver Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39938653 | Derived | Harrison SA, Alkhouri N, Ortiz-Lasanta G, Rudraraju M, Tai D, Wack K, Shah A, Besuyen R, Steineger HH, Fraser DA, Sanyal AJ; ICONA Study Investigators. A phase IIb randomised-controlled trial of the FFAR1/FFAR4 agonist icosabutate in MASH. J Hepatol. 2025 Aug;83(2):293-303. doi: 10.1016/j.jhep.2025.01.032. Epub 2025 Feb 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo oral capsules taken one daily for 52 weeks Placebo: Matching placebo oral capsule |
| FG001 | Icosabutate 300mg | Icosabutate 300mg oral capsule taken once daily for 52 weeks Icosabutate: Icosabutate oral capsule once daily |
| 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 | Jul 21, 2022 | Nov 15, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo oral capsule |
|
| 52 weeks |
| Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | 52 weeks |
| Change in Bilirubin Micromol/L From Baseline | 52 weeks |
| Change From Baseline in Inflammation Marker hsCRP | 52 weeks |
| Change From Baseline in Fibrosis Activity Marker Pro-C3 | 52 weeks |
| Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test | ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter. | 52 weeks |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose [mmol/L)] × fasting insulin [mIU/L]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range. | 52 weeks |
| Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis) | The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease. | 52 weeks |
| Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease | 52 weeks |
| Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity | 52 weeks |
| Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF) | MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity. | 52 weeks |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Arizona Liver Health - Glendale | Glendale | Arizona | 85306 | United States |
| Arizona Liver Health | Tucson | Arizona | 85711 | United States |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | United States |
| Arkansas Gastroenterology - North Little Rock | North Little Rock | Arkansas | 72117 | United States |
| Fresno Clinical Research Center | Fresno | California | 93720 | United States |
| National Research Institute - Huntington Park | Huntington Park | California | 90255 | United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| National Research Institute - Panorama | Panorama City | California | 91402 | United States |
| Alliance Clinical Research | Poway | California | 92064 | United States |
| National Research Institute - Santa Ana | Santa Ana | California | 92704 | United States |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | United States |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | United States |
| Sensible Healthcare LLC | Ocoee | Florida | 34761 | United States |
| Covenant Research LLC | Sarasota | Florida | 34240 | United States |
| Gastrointestinal Specialists of Georgia PC | Marietta | Georgia | 30060 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Texas Digestive Disease Consultants | Baton Rouge | Louisiana | 70809 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Gastrointestinal Associates, PA | Flowood | Mississippi | 39232 | United States |
| Southern Therapy and Advanced Research LLC | Jackson | Mississippi | 39216 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | United States |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | United States |
| Premier Research | Clarksville | Tennessee | 37040 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Pinnacle Clinical Research | Austin | Texas | 78746 | United States |
| Texas Digestive Disease Consultants | Dallas | Texas | 75246 | United States |
| South Texas Research Institute | Edinburg | Texas | 78539 | United States |
| Liver Associates of Texas | Houston | Texas | 77030 | United States |
| Doctors Hospital at Renaissance, LLC | McAllen | Texas | 78504 | United States |
| Quality Research Inc | San Antonio | Texas | 78209 | United States |
| American Research Corporation | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| Texas Digestive Disease Consultants - Webster | Webster | Texas | 77598 | United States |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Fundacion de Investigacion (FDI) | San Juan | 00927-4807 | Puerto Rico |
| FG002 | Icosabutate 600mg | Icosabutate 600mg oral capsules taken once daily for 52 weeks Icosabutate: Icosabutate oral capsule once daily |
| Safety Population |
|
| ITT | The Intent-to-Treat Population included all patients who were randomized and received at least 1 dose of study drug. |
|
| mITT | Modified Intent-To-Treat Population - The mITT population included all patients from the ITT Population who had valid baseline and Week 52 (or ET, if applicable) liver biopsy measurements; a valid Week 52/ET liver biopsy was defined as a liver biopsy that had occurred within 90 days of last dose/Week 52 visit. |
|
| 3-Panel mITT | The 3-Panel mITT Population included all patients who had a baseline and Week 52 (or ET, if applicable) liver biopsy read and fulfilled eligibility criteria based on the 3-panel read paradigm. This population was considered the primary population for the efficacy analysis of the histology data. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Modified Intent-To-Treat (mITT) Population is used for the baseline analysis population as this was the primary population for efficacy analysis. The mITT Population included all patients from the ITT Population who had valid baseline and Week 52 (or ET, if applicable) liver biopsy measurements; a valid Week 52/ET liver biopsy was defined as a liver biopsy that had occurred within 90 days of last dose/Week 52 visit.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo oral capsules taken one daily for 52 weeks Placebo: Matching placebo oral capsule |
| BG001 | Icosabutate 300mg | Icosabutate 300mg oral capsule taken once daily for 52 weeks Icosabutate: Icosabutate oral capsule once daily |
| BG002 | Icosabutate 600mg | Icosabutate 600mg oral capsules taken once daily for 52 weeks Icosabutate: Icosabutate oral capsule once daily |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Alcohol use | Count of Participants | Participants |
| ||||||||||||||||
| Type 2 Diabetes status | 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 | Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis. | 3-Panel Modified Intent-To-Treat (mITT) Population - The 3-Panel mITT Population included all patients who had a baseline and Week 52 (or ET, if applicable) liver biopsy read and fulfilled eligibility criteria based on the 3-panel read paradigm. This population was considered the primary population for the efficacy analysis of the histology data. Biopsy fibrosis score F2/F3 | Posted | Number | percentage of participants | 52 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning). | 3-Panel mITT population. Biopsy fibrosis score F2/F3 | Posted | Number | percentage of participants | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement. | 3-Panel mITT population. Biopsy fibrosis score F2/F3. | Posted | Number | percentage of participants | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52. | Posted | Least Squares Mean | Standard Error | U/L | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bilirubin Micromol/L From Baseline | Results are presented for those participants in the 3-panel mITT population who had results for this parameter at Week 52 | Posted | Least Squares Mean | Standard Error | micromol/L | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Inflammation Marker hsCRP | 3-panel mITT population | Posted | Least Squares Mean | Standard Error | mg/L | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fibrosis Activity Marker Pro-C3 | Results are presented for those participants in the 3-panel mITT population who had results for this parameter at Week 52 | Posted | Least Squares Mean | Standard Error | micrograms/L | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test | ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter. | Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52. | Posted | Least Squares Mean | Standard Error | score | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose [mmol/L)] × fasting insulin [mIU/L]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range. | 3-panel mITT population | Posted | Least Squares Mean | Standard Error | score | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis) | The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease. | Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease | Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity | 3-panel mITT population | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF) | MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity. | Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52. | Posted | Mean | Standard Deviation | Percentage of fat | 52 weeks |
|
|
AEs, which included clinical laboratory test variables, were monitored and documented from the time the patient signed the ICF until Visit 10 (Week 54) or the Early Termination visit (if applicable).
Not provided
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 | Placebo | Placebo oral capsules taken one daily for 52 weeks Placebo: Matching placebo oral capsule | 1 | 91 | 4 | 91 | 82 | 91 |
| EG001 | Icosabutate 300mg | Icosabutate 300mg oral capsule taken once daily for 52 weeks Icosabutate: Icosabutate oral capsule once daily | 0 | 92 | 5 | 92 | 80 | 92 |
| EG002 | Icosabutate 600mg | Icosabutate 600mg oral capsules taken once daily for 52 weeks Icosabutate: Icosabutate oral capsule once daily | 1 | 95 | 8 | 95 | 80 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Intra-abdominal hematoma | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | 22.0 | Non-systematic Assessment |
| |
| Spinal claudication | Nervous system disorders | 22.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 22.0 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | 22.0 | Non-systematic Assessment |
| |
| Post-procedural hematoma | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Coronavirus test positive | Investigations | 22.0 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 22.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | 22.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 22.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | 22.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 22.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | 22.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Low-density lipoprotein increased | Investigations | 22.0 | Non-systematic Assessment |
| |
| Coronavirus test positive | Investigations | 22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 22.0 | Non-systematic Assessment |
| |
| Glycosylated hemoglobin increased | Investigations | 22.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | 22.0 | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | 22.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | 22.0 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | 22.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | 22.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 22.0 | Non-systematic Assessment |
|
Each Investigator is obligated to keep data pertaining to the study confidential. The Investigator must consult with the Sponsor before any study data are submitted for publication. The Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | NorthSea Therapeutics BV | 31 035760 65 05 | info@northseatherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2023 | Nov 15, 2024 | 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 |
|---|---|
| C000626078 | icosabutate |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Former |
|
| Never |
|
| Missing |
|
| Non-diabetic |
|
| 0.1386 |
| Odds Ratio (OR) |
| 2.01 |
| 2-Sided |
| 95 |
| 0.80 |
| 5.08 |
| Other |
Cochran-Mantel-Haenszel Test |
|
|
|
|
|
|
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|