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This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local regulatory authority.
Patients clinically suspected of NASH will be invited for a screening programme for inclusion in the study. Patients will be screened according to the inclusion and exclusion criteria. Clinical evaluation will be conducted for baseline characteristics and anthropometry measurements such as body weight and height.
After clinical evaluations, all baseline safety and efficacy parameters will be recorded as per Visit Schedule. All laboratory collections will be performed following overnight fasting (at least 8 hrs).
Following confirmation of all clinical and laboratory inclusion and exclusion criteria, patients will continue into the screening period. During the screening period liver biopsy will be performed. However, if a biopsy was performed within 6 months the slides and biopsy material, or block, must be made available for baseline documentation. Such Patients, whose historical biopsy report is available, should not use medication suspected of having an effect on NASH from the 3 months prior to the screening.
Liver biopsy will be performed to confirm the diagnosis of NASH and record a baseline Non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS). The histological evidence of NASH is defined as NAS ≥ 4 with a minimum score of 1 for all of its three components [steatosis, hepatocyte ballooning and lobular inflammation].
Following confirmation of inclusion/exclusion criteria and upon histological confirmation of NASH by liver biopsy, patients will be enrolled into the study.
Eligible patients will be randomly assigned to receive Saroglitazar Magnesium 2 mg or 4 mg or placebo in a 2:2:1 ratio for 24 weeks.
Upon completion of 24 weeks of treatment, liver biopsy will be performed and the NAFLD Activity Score recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saroglitazar Magnesium 2 mg | Experimental | Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast for 24 weeks. |
|
| Saroglitazar Magnesium 4 mg | Experimental | Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast for 24 weeks. |
|
| Placebo | Placebo Comparator | Placebo tablet orally once daily in the morning before breakfast for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saroglitazar Magnesium 2mg | Drug | Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NAS Score (Nonalcoholic Fatty Liver Disease [NAFLD] Activity Score) | The primary endpoint is to assess the changes in NAFLD Activity Score (NAS) at week 24 from baseline and with no worsening of fibrosis in NASH patients. NAFLD Activity Score Steatosis <5% - 0 5% -33% - 1 >33% -66% - 2 >66% - 3 Lobular Inflammation No foci - 0 <2 foci per 200 X field -1 2-4 foci per 200 X field - 2 >4 foci per 200 X field - 3 Ballooning None - 0 Few balloon cells -1 Many cells/prominent ballooning - 2 Final NAFLD Activity Score = Steatosis Score + Lobular Inflammation Score + Ballooning Score Minimum score for NAS is 0 Maximum score for NAS is 8 Higher score represents the worse disease activity | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Percentage of Responders in the Treatment Groups. | Responder is defined as a decrease from baseline of at least 2 points spread across at least 2 of the NAS components [steatosis, hepatocyte ballooning, and lobular inflammation] with no worsening of fibrosis. | Baseline to Week 24 |
| Percentage of Responders Defined by the Disappearance of Steatohepatitis. |
Not provided
Inclusion Criteria:
Patients able to provide written informed consent for participation in this trial.
Males or females, 18 to 75 years of age, both inclusive.
Female must be either of non-child bearing potential (surgically sterilized at least 6 months prior to screening or postmenopausal) or using one or more methods of contraception.
Histologic confirmation of NASH without cirrhosis (fibrosis stage 0, 1, 2, or 3) from liver biopsy performed either during the screening period or no more than 6 months prior to the first visit, with a NAS of ≥4 and a score of at least 1 in each (steatosis scored 0-3, ballooning scored 0-2, and lobular inflammation scored 0-3). If biopsy was performed within 6 months of screening, the slides, biopsy material or block should be available for baseline documentation. Such patients, whose historical biopsy report is available, should not use medications suspected of having an effect on NASH for at least 3 months prior to the screening.
BMI ≥25 kg/m^2.
For hypertensive patients, blood pressure must be controlled by a stable dose of antihypertensive medications for at least 3 months prior to screening (and the stable dose can be maintained throughout the study)
Patients with type 2 diabetes mellitus may be included if they fulfil the following criteria;
Patients agree to comply with the study procedure.
Exclusion Criteria:
Pregnant and lactating female.
Positive pregnancy test.
Patients with history of myopathies or evidence of active muscle diseases.
Patients with history of alcohol consumption of >30 gm/day for men, >20 gm/day for women for consecutive previous 2 years and/or drug abuse.
Known allergy, sensitivity or intolerance to the study drug or formulation ingredients.
Participation in an interventional clinical study and/or receipt of any investigational medication within 3 months prior to screening.
History of malignancy in the past 5 years and/or active neoplasm with the exception of superficial, non-melanoma, skin cancer.
Any of the following laboratory values at screening:
Unstable cardiovascular disease, including:
Previous history of bladder disease and/or hematuria.
Previous liver biopsy that demonstrated presence of cirrhosis or radiologic imaging consistent with cirrhosis or portal hypertension.
Type 1 diabetes mellitus.
Use of drugs that are known Cytochrome P4502C8 (CYP2C8) inhibitors/substrate.
Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the 1 year prior to start of the study; (these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens, valproate/valproic acid, chloroquine, anti-HIV drugs).
History of thyroid disease (hypothyroid patients who are euthyroid on thyroid hormone replacement can be included).
History of, or current, cardiac dysrhythmias.
History of bariatric surgery, or undergoing evaluation for bariatric surgery.
Patients with a >10% weight loss in the 3 months prior to screening.
History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the Investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, HIV or active gastrointestinal conditions that might interfere with drug absorption).
Patients on any treatment with other drugs used for treatment of NASH [pentoxyphyllin, ursodeoxycholic acid, antioxidants such as vitamin E (>800 IU/day), glutathione, orlistat, betaine, incretin mimetics or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations and special teas)] or any medicine in clinical trials for NASH. (However, patients who are taking stable dose of vitamin E for at least 3 months prior to screening will be enrolled in the study).
History of other causes of chronic liver disease [autoimmune, primary biliary cirrhosis, hepatitis B virus (HBV) and hepatitis C virus (HCV), Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Deven V Parmar, MD,FACP,FCP | Zydus Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Therapy and Advanced Research (STAR) LLC | Jackson | Mississippi | 39216 | United States | ||
| Gastro One |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36731585 | Background | Siddiqui MS, Parmar D, Sheikh F, Sarin SK, Cisneros L, Gawrieh S, Momin T, Duseja A, Sanyal AJ. Saroglitazar, a Dual PPAR alpha/gamma Agonist, Improves Atherogenic Dyslipidemia in Patients With Non-Cirrhotic Nonalcoholic Fatty Liver Disease: A Pooled Analysis. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2597-2605.e2. doi: 10.1016/j.cgh.2023.01.018. Epub 2023 Jan 31. | |
| 33152542 |
| Label | URL |
|---|---|
| Siddiqui MS, Parmar D. Saroglitazar, a Dual PPAR alpha/gamma Agonist, Improves Atherogenic Dyslipidemia in Patients With Non-Cirrhotic Nonalcoholic Fatty Liver Disease: A Pooled Anal | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saroglitazar Magnesium 2 mg | Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 2mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks. |
| FG001 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 4mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks. |
| FG002 | Placebo | Placebo tablet orally once daily in the morning before breakfast for 24 weeks. Placebos: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saroglitazar Magnesium 2 mg | Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 2mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks. |
| BG001 | Saroglitazar Magnesium 4 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | NAS Score (Nonalcoholic Fatty Liver Disease [NAFLD] Activity Score) | The primary endpoint is to assess the changes in NAFLD Activity Score (NAS) at week 24 from baseline and with no worsening of fibrosis in NASH patients. NAFLD Activity Score Steatosis <5% - 0 5% -33% - 1 >33% -66% - 2 >66% - 3 Lobular Inflammation No foci - 0 <2 foci per 200 X field -1 2-4 foci per 200 X field - 2 >4 foci per 200 X field - 3 Ballooning None - 0 Few balloon cells -1 Many cells/prominent ballooning - 2 Final NAFLD Activity Score = Steatosis Score + Lobular Inflammation Score + Ballooning Score Minimum score for NAS is 0 Maximum score for NAS is 8 Higher score represents the worse disease activity | modified intention-to-treat | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 24 |
|
24 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saroglitazar Magnesium 2 mg | Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 2mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Deven Parmar | Zydus Therapeutics Inc. | 7324050886 | dparmar@zydustherapeutics.com |
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 | Aug 2, 2018 | Dec 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2020 | Dec 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
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| ID | Term |
|---|---|
| C000588741 | saroglitazar |
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| Saroglitazar Magnesium 4mg | Drug | Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks. |
|
| Placebos | Drug | Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
|
Percentage of responders defined by the disappearance of steatohepatitis |
| Baseline to Week 24 |
| Changes in the Stage of Steatosis, Lobular Inflammation and Ballooning. | Changes in the stage of steatosis, lobular inflammation and ballooning by evaluating the NAS Score (Nonalcoholic fatty liver disease Activity Score) Steatosis <5% - 0 5% -33% - 1 >33% -66% - 2 >66% - 3 Lobular Inflammation No foci - 0 <2 foci per 200 X field -1 2-4 foci per 200 X field - 2 >4 foci per 200 X field - 3 Ballooning None - 0 Few balloon cells -1 Many cells/prominent ballooning - 2 Higher score represents the worse disease activity | Baseline to Week 24 |
| Changes in the Stage of Fibrosis. | Changes in the stage of fibrosis by evaluating the Fibrosis stages Fibrosis Score Definition None - 0 Perisinusoidal or periportal - 1 Mild, zone 3, perisinusoidal - 1A Moderate, zone3, perisinusoidal -1B Portal/periportal -1C Perisinusoidal and portal/periportal - 2 Bridging fibrosis - 3 Cirrhosis - 4 Higher score represents the worse disease activity | Baseline to Week 24 |
| Changes in the Liver Function Tests; (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Alkaline Phosphatases [ALP], and Gamma-glutamyl Transferase [GGT]). | Liver function tests include ALT, AST, ALP, GGT | Baseline to Week 24 |
| Changes in the Liver Function Tests; Albumin and Total Protein | Changes in albumin and total protein | Baseline to Week 24 |
| Changes in the Liver Function Tests; Direct Bilirubin | Change in direct bilirubin | Baseline to Week 24 |
| Changes in the Lipid Profile. | Evaluation of Lipid profile parameters | Baseline to Week 24 |
| Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium 2 mg and 4 mg | Number of Participants with Adverse Events. | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance; Fasting Plasma Glucose | Evaluation of Fasting Plasma Glucose | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance; Hemoglobin A1c | Evaluation of Hemoglobin A1c | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance; Insulin | Evaluation of Insulin | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance: C-peptide | Evaluation of C-peptide | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance: Homeostasis Model Assessment of Beta Cell Function (HOMA -β) | Evaluation of HOMA of Beta Cell Function Homeostasis model assessment of beta cell function measures as following; HOMA -β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}. HOMA-B provides a quantitative estimate of beta-cell function. A lower HOMA-B value indicates reduced beta-cell function, which can be a sign of progressing towards or already having type 2 diabetes. Conversely, a higher HOMA-B value suggests better beta-cell functionality. | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance: HOMA of Insulin Resistance | Evaluation of HOMA of Insulin Resistance Insulin Resistance Index measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | Baseline to Week 24 |
| Changes in the Glycemic Control and Insulin Resistance: Total Adiponectin | Evaluation of Total Adiponectin | Baseline to Week 24 |
| Germantown |
| Tennessee |
| 38138 |
| United States |
| Digestive Health Research | Hermitage | Tennessee | 37076 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Siddiqui MS, Idowu MO, Parmar D, Borg BB, Denham D, Loo NM, Lazas D, Younes Z, Sanyal AJ. A Phase 2 Double Blinded, Randomized Controlled Trial of Saroglitazar in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2670-2672. doi: 10.1016/j.cgh.2020.10.051. Epub 2020 Nov 2. |
| Siddiqui MS, Idowu MO, Parmar D, Borg BB, Denham D, Loo NM, Lazas D, Younes Z, Sanyal AJ. A Phase 2 Double Blinded, Randomized Controlled Trial of Saroglitazar in Patients With Nonalcoholic Steatohepatitis | View source |
Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 4mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks. |
| BG002 | Placebo | Placebo tablet orally once daily in the morning before breakfast for 24 weeks. Placebos: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 4mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks. |
| OG002 | Placebo | Placebo tablet orally once daily in the morning before breakfast for 24 weeks. Placebos: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
|
|
|
| Secondary | To Evaluate the Percentage of Responders in the Treatment Groups. | Responder is defined as a decrease from baseline of at least 2 points spread across at least 2 of the NAS components [steatosis, hepatocyte ballooning, and lobular inflammation] with no worsening of fibrosis. | modified intent-to-treat population | Posted | Count of Participants | Participants | Baseline to Week 24 |
|
|
|
|
| Secondary | Percentage of Responders Defined by the Disappearance of Steatohepatitis. | Percentage of responders defined by the disappearance of steatohepatitis | modified intent-to-treat population | Posted | Count of Participants | Participants | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Stage of Steatosis, Lobular Inflammation and Ballooning. | Changes in the stage of steatosis, lobular inflammation and ballooning by evaluating the NAS Score (Nonalcoholic fatty liver disease Activity Score) Steatosis <5% - 0 5% -33% - 1 >33% -66% - 2 >66% - 3 Lobular Inflammation No foci - 0 <2 foci per 200 X field -1 2-4 foci per 200 X field - 2 >4 foci per 200 X field - 3 Ballooning None - 0 Few balloon cells -1 Many cells/prominent ballooning - 2 Higher score represents the worse disease activity | modified intent-to-treat population | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Stage of Fibrosis. | Changes in the stage of fibrosis by evaluating the Fibrosis stages Fibrosis Score Definition None - 0 Perisinusoidal or periportal - 1 Mild, zone 3, perisinusoidal - 1A Moderate, zone3, perisinusoidal -1B Portal/periportal -1C Perisinusoidal and portal/periportal - 2 Bridging fibrosis - 3 Cirrhosis - 4 Higher score represents the worse disease activity | Modified intent-to-treat population | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Liver Function Tests; (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Alkaline Phosphatases [ALP], and Gamma-glutamyl Transferase [GGT]). | Liver function tests include ALT, AST, ALP, GGT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | U/L | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Liver Function Tests; Albumin and Total Protein | Changes in albumin and total protein | Modified intend-to-treat population | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Liver Function Tests; Direct Bilirubin | Change in direct bilirubin | Modified intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Lipid Profile. | Evaluation of Lipid profile parameters | Modified intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 24 |
|
|
|
|
| Secondary | Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium 2 mg and 4 mg | Number of Participants with Adverse Events. | Safety Population | Posted | Count of Participants | Participants | Baseline to Week 24 |
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance; Fasting Plasma Glucose | Evaluation of Fasting Plasma Glucose | modified intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance; Hemoglobin A1c | Evaluation of Hemoglobin A1c | modified intent-to-treat population | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance; Insulin | Evaluation of Insulin | modified intent-to-treat population | Posted | Mean | Standard Deviation | μIU/mL | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance: C-peptide | Evaluation of C-peptide | modified intent-to-treat population | Posted | Mean | Standard Deviation | ng/mL | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance: Homeostasis Model Assessment of Beta Cell Function (HOMA -β) | Evaluation of HOMA of Beta Cell Function Homeostasis model assessment of beta cell function measures as following; HOMA -β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}. HOMA-B provides a quantitative estimate of beta-cell function. A lower HOMA-B value indicates reduced beta-cell function, which can be a sign of progressing towards or already having type 2 diabetes. Conversely, a higher HOMA-B value suggests better beta-cell functionality. | modified intent-to-treat population | Posted | Mean | Standard Deviation | percentage of HOMA of Beta Cell Function | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance: HOMA of Insulin Resistance | Evaluation of HOMA of Insulin Resistance Insulin Resistance Index measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | modified intent-to-treat population | Posted | Mean | Standard Deviation | percentage of HOMA of Insulin Resistance | Baseline to Week 24 |
|
|
|
|
| Secondary | Changes in the Glycemic Control and Insulin Resistance: Total Adiponectin | Evaluation of Total Adiponectin | modified intent-to-treat population | Posted | Mean | Standard Deviation | μg/mL | Baseline to Week 24 |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast for 24 weeks. Saroglitazar Magnesium 4mg: Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks. | 0 | 7 | 2 | 7 | 5 | 7 |
| EG002 | Placebo | Placebo tablet orally once daily in the morning before breakfast for 24 weeks. Placebos: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. | 0 | 3 | 0 | 3 | 2 | 3 |
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Appendicitis | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Fungal infection | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | Systematic Assessment |
|
| Tooth infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Uvulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Akathisia | Nervous system disorders | Systematic Assessment |
|
| Amnesia | Nervous system disorders | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hot flush | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Weight increased | Investigations | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Allergy to animal | Immune system disorders | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Other |
| Other |
Proof-of-concept |
|
| Changes in the stage of ballooning |
|
| 0.4625 |
| Other |
Proof-of-concept |
| Outcome Variable: Lobular Inflammation | t-test, 2 sided | 0.1705 | Other | Proof-of-concept |
| Outcome variable: Lobular Inflammation | t-test, 2 sided | 0.3122 | Other | Proof-of-concept |
| Outcome Variable: Hepatocyte Ballooning | t-test, 2 sided | 0.1705 | Other | Proof-of-concept |
| Outcome Variable: Hepatocyte Ballooning | t-test, 2 sided | 0.3877 | Other | Proof-of-concept |
| Other |
Proof-of-concept |
|
| Change in ALP |
|
| Change in GGT |
|
| 0.5396 |
| Other |
Proof-of-concept |
| Outcome Variable: Aspartate Aminotransferase | t-test, 2 sided | 0.7740 | Other | Proof-of-concept |
| Outcome Variable: Aspartate Aminotransferase | t-test, 2 sided | 0.9221 | Other | Proof-of-concept |
| Outcome Variable: Alkaline Phosphatase | t-test, 2 sided | 0.0030 | Other | Proof-of-concept |
| Outcome Variable: Alkaline Phosphatase | t-test, 2 sided | 0.0177 | Other | Proof-of-concept |
| Outcome Variable: Gamma Glutamyl Transferase | t-test, 2 sided | 0.1399 | Other | Proof-of-concept |
| Outcome Variable: Gamma Glutamyl Transferase | t-test, 2 sided | 0.2384 | Other | Proof-of-concept |
|
| 0.1483 |
| Other |
Proof-of-Concept |
| Outcome Variable: Total Protein | t-test, 2 sided | 0.0839 | Other | Proof-of-concept |
| Outcome Variable: Total Protein | t-test, 2 sided | 0.2895 | Other | Proof-of-concept |
| 0.5351 |
| Other |
Proof-of-concept |
|
| Change in Small dense LDL |
|
| Change in High-density Lipoprotein |
|
| Change in Low-density lipoprotein |
|
| Change in Very low-density lipoprotein |
|
| Change in non-HDL Cholesterol |
|
| Change in Apo lipoprotein A1 |
|
| Change in Apo lipoprotein B |
|
| 0.7211 |
| Other |
Proof-of-concept |
| Outcome Variables: Total Cholesterol | t-test, 2 sided | 0.6520 | Other | Proof-of-concept |
| Outcome Variable: Total Cholesterol | t-test, 2 sided | 0.4302 | Other | Proof-of-concept |
| Outcome Variable: High-density Lipoprotein | t-test, 2 sided | 0.9432 | Other | Proof-of-concept |
| Outcome Variable: High-density Lipoprotein | t-test, 2 sided | 0.2133 | Other | Proof-of-concept |
| Outcome Variable: Low-density lipoprotein | t-test, 2 sided | 0.2446 | Other | Proof-of-concept |
| Outcome Variable: Low-density lipoprotein | t-test, 2 sided | 0.7075 | Other | Proof-of-concept |
| Outcome Variable: Very low-density lipoprotein | t-test, 2 sided | 0.2195 | Other | Proof-of-concept |
| Outcome Variable: Very low-density lipoprotein | t-test, 2 sided | 0.7435 | Other | Proof-of-concept |
| Outcome Variable: non-HDL Cholesterol | t-test, 2 sided | 0.5702 | Other | Proof-of-concept |
| Outcome Variable: non-HDL Cholesterol | t-test, 2 sided | 0.6441 | Other | Proof-of-concept |
| Outcome Variable: Apo lipoprotein A1 | t-test, 2 sided | 0.8415 | Other | Proof-of-concept |
| Outcome Variable: Apo lipoprotein A1 | t-test, 2 sided | 0.0786 | Other | Proof-of-concept |
| Outcome Variable: Apo lipoprotein B | t-test, 2 sided | 0.8878 | Other | Proof-of-concept |
| Outcome variable: Apo lipoprotein B | t-test, 2 sided | 0.3219 | Other | Proof-of-concept |
| Outcome Variable: Small dense LDL | t-test, 2 sided | 0.6557 | Other | Proof-of-concept |
| Outcome Variable: Small dense LDL | t-test, 2 sided | 0.0763 | Other | Proof-of-concept |
| Other |
Proof-of-concept |
| Other |
Proof-of-concept |
| Other |
Proof-of-concept |
| Other |
Proof-of-concept |
| Other |
Proof-of-concept |
| Other |
Proof-of-concept |
| Other |
Proof-of-concept |