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Sponsor Decision
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Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living with Human Immunodeficiency Virus (HIV) in the US
The four participants enrolled on version 3.0 protocol were terminated as the primary endpoint was revised from biopsy to an imaging-based approach in the subsequent protocol version 4.0. These changes were done due to recruiting challenges pertaining to biopsy. However, no participants were enrolled in the revised protocol (version 4.0) as, by then the decision to terminate the study was taken by the Sponsor considering the modifications in the internal R&D focus and a revised commercialization strategy.
The version 3.0 protocol is dated 02/Jun/2022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saroglitazar Magnesium 4 mg | Experimental | Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks) |
|
| Placebo Arm | Placebo Comparator | Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saroglitazar Magnesium 4 mg | Drug | Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Hepatic Fat Content Measured by MRI Proton Density Fat Fraction (MRI PDFF) | Change from baseline in hepatic fat content | Week 24/EOT |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Reduction of Hepatic Fat Content as Measured by MRI PDFF. | Proportion of participants with reduction of at least 30% in hepatic fat content from baseline | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE . |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium Compared to Placebo | Number of Participants with Adverse Events. We have included data for Treatment emergent adverse events (TEAEs) only. TEAEs are those AEs that occur after administration of the study drug. | From baseline to Week 28 |
Inclusion Criteria:
Exclusion Criteria:
History of significant alcohol consumption (defined as >2 drinks/day on average for men, >1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening (Note 1: 1 drink =12 ounces of beer, 8-9 ounces of malt liquor, 4 ounces of wine or 1 ounce of spirits/hard liquor. Note 2: Use sex assigned at birth for alcohol consumption limits).
History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity. (Exceptions: a. Participants with previously treated hepatitis C infection are eligible for consideration if their sustained virologic response was achieved more than 3 years prior to screening. The proportion of such participants in this trial will not exceed 25% of the study cohort. b. Participants with prior acute HBV infection that is resolved but currently do not have hepatitis B surface antigen (HBsAg) or detectable HBV DNA are eligible).
History of liver transplant.
Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
Note: These participants will be required to have a third value measured at-least one week after V2, to assess for a trend. If the third value shows a continued increase ≥10% compared to the Visit 2 values, the participant is considered ineligible for randomization.
Ongoing use of steatogenic medications or supra-physiologic hormonal therapies (Exception: transgender women on stable (≥3 month) feminizing hormonal therapy not excluded), within 3 months prior to screening until time of randomization or anticipated use of medications that cause significant changes in weight during the study period (Refer Appendix 7 of protocol for 'List of Steatogenic Medications Or Supra-Physiologic Hormonal Therapies Or Medications That Cause Significant Weight Change').
Uncontrolled T2DM, defined as HbA1c >9.5% at screening.
Any of the following laboratory values at screening:
History of malignancy in the past 5 years and/or active neoplasm with the exception of superficial, non-melanoma, skin cancer.
Unstable cardiovascular disease, including:
Unstable pulmonary disease (based upon site investigator's evaluation) at screening.
Use of drugs that are known CYP2C8 inhibitors/substrates (Refer Appendix 2 of protocol for the 'List of Known CYP2C8 Inhibitors/Substrates') in the last 28 days prior to screening.
History of severe illness or any other conditions that require systematic treatment/or hospitalization, until participant either completes therapy or is clinically stable on therapy as per the opinion of the investigator, for at least 7 days prior to screening (such as poorly controlled psychiatric disease, active gastrointestinal conditions that might interfere with drug absorption, etc.).
Use of thiazolidinediones or Telmisartan within 3 months prior to screening or until time of randomization.
Use of unstable doses of SGLT2 inhibitors (e.g. canagliflozin, empagliflozin, dapagliflozin, etc.), glucose-dependent insulinotropic polypeptide (GIP) and/or GLP-1 agonists (e.g. semaglutide, exenatide, liraglutide, lixisenatide, tirzepatide etc.) within 6 months prior to screening until time of randomization.
Use of pentoxifylline, ursodeoxycholic acid, antioxidants such as vitamin E (>200 IU/day), glutathione, orlistat, betaine, or non-prescribed complementary alternative medications within 6 months prior to screening until time of randomization.
Known allergy, sensitivity or intolerance to the study medication or formulation ingredients.
History of any known bleeding disorder or coagulopathy.
Any condition that in the opinion of the site investigator, would compromise the participant's ability to participate in the study.
Unstable doses of anti-diabetic agents including sulfonylureas, biguanides or DPP-4 inhibitors in the last 3 months prior to screening until time of randomization.
Unstable doses of lipid lowering agents such as statins (e.g. simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin, etc.) or fibrates (clofibrate, Fenofibrate) in the last 3 months prior to screening until time of randomization.
Participant with weight change >5% within 6 months prior to screening until time of randomization.
History of bariatric surgery or currently undergoing evaluation for bariatric surgery.
Participation in another interventional clinical study and/or receipt of any other investigational medication within 3 months prior to screening.
History of COVID-19 infection in the last 30 days prior to screening.
Pregnancy-related exclusions, include:
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| Name | Affiliation | Role |
|---|---|---|
| Deven V Parmar | Zydus Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zydus US004 | Birmingham | Alabama | 35294-2050 | United States | ||
| Zydus US005 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks) Saroglitazar Magnesium 4 mg: Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2023 | Mar 27, 2025 |
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This phase 2a study is a randomized, placebo-controlled, double-blind, parallel arm trial to evaluate the safety and efficacy of Saroglitazar Magnesium 4 mg compared with placebo in biopsy-proven NAFLD in people living with HIV (PLWH). Eligible participants will be randomized in a 1:1 ratio to receive Saroglitazar Magnesium 4 mg or placebo.
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| Placebo | Drug | Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). |
|
Change from baseline in Liver Stiffness Measurement |
| Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE | Change from baseline in Continuous Controlled Attenuation Parameter | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/Vibration-controlled Transient Elastography (VCTE). | Change from baseline in Fibroscan-aspartate aminotransferase (FAST) score | Week 24/EOT |
| To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change from baseline in plasma pro-collagen type 3 (PRO-C3) levels | Week 24/EOT |
| To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change from baseline in Fibrois-4 index (FIB-4) This index is based on age, platelet count, ALT level, and AST level. FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10^9/L) x √ALT (U/L)). A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of <1.45 indicates none to moderate fibrosis and an Index of >3.25 indicates advanced fibrosis. | Week 24/EOT |
| To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change in aspartate aminotransferase-to-platelet ratio index in Saroglitazar Magnesium groups as compared to the placebo group APRI was calculated as ([AST level/AST upper limit of normal]/ [Platelet count 1^09/L]) ×100, where AST is aspartate aminotransferase. The aspartate transaminase to platelet ratio index (APRI) is used to assess the risk of liver fibrosis. Higher APRI score represents a higher risk of liver fibrosis | Week 24/EOT |
| To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change from baseline in Nonalcoholic fatty liver disease Fibrosis Score (NFS) The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. NFS was calculated using the following formula: NAFLD fibrosis score = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A decrease in NFS score represents a positive outcome. An NFS score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis. | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Liver Enzyme | Change from baseline in liver enzyme parameters (ALT and AST) | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Lipid Profile | Change from baseline in triglyceride [TG), high-density lipoprotein [HDL], low-density lipoprotein [LDL], very low-density lipoprotein [VLDL], total cholesterol, and non-HDL cholesterol](streamdown:incomplete-link) | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Fasting Glucose | Change from baseline in fasting plasma glucose (FPG) | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements. | Change from baseline in body weight | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements. | Change from baseline in BMI | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements. | Change from baseline in hip circumference and minimum waist circumference | Week 24/EOT |
| To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Health-related Quality of Life Scores Measured by Short Form-36 (SF-36) Questionnaire. | Change from baseline in SF-36 Questionnaire mental (MCS) and physical components scores (PCS). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as the worst health status. | Week 24/EOT. |
| La Jolla |
| California |
| 92037 |
| United States |
| Zydus US006 | San Francisco | California | 94143 | United States |
| Zydus US002 | Indianapolis | Indiana | 46202 | United States |
| Zydus US003 | Baltimore | Maryland | 21287 | United States |
| Zydus US001 | Durham | North Carolina | 27710 | United States |
| Zydus US007 | Houston | Texas | 77030 | United States |
| Zydus US008 | Richmond | Virginia | 23298 | United States |
| FG001 |
| Placebo Arm |
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). Placebo: Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks) Saroglitazar Magnesium 4 mg: Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks). |
| BG001 | Placebo Arm | Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). Placebo: Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). |
| BG002 | 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 |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Hepatic Fat Content Measured by MRI Proton Density Fat Fraction (MRI PDFF) | Change from baseline in hepatic fat content | The 4 participants were enrolled under protocol V3.0, with biopsy-driven primary endpoint. Due to recruitment challenges, the outcome measure was modified to MRI-PDFF in the protocol V4.0. All 4 participants were prematurely terminated before completing their planned treatment before any efficacy data could be collected. No participants were enrolled under the revised protocol V4.0 as the study was terminated. Consequently, no MRI-PDFF based efficacy data were collected or analyzed | Posted | Week 24/EOT |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Reduction of Hepatic Fat Content as Measured by MRI PDFF. | Proportion of participants with reduction of at least 30% in hepatic fat content from baseline | The 4 participants were enrolled under protocol V3.0, with biopsy-driven primary endpoint. Due to recruitment challenges, the outcome measure was modified to MRI-PDFF in the protocol V4.0. All 4 participants were prematurely terminated before completing their planned treatment and before any efficacy data could be collected. No participants were enrolled under the revised protocol V4.0 as the study was terminated. Consequently, no MRI-PDFF based efficacy data were collected or analyzed | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE . | Change from baseline in Liver Stiffness Measurement | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no Liver Stiffness Measurement data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE | Change from baseline in Continuous Controlled Attenuation Parameter | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no Continuous Controlled Attenuation Parameter data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/Vibration-controlled Transient Elastography (VCTE). | Change from baseline in Fibroscan-aspartate aminotransferase (FAST) score | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no Fibroscan-aspartate aminotransferase score data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change from baseline in plasma pro-collagen type 3 (PRO-C3) levels | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no plasma pro-collagen type 3 data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change from baseline in Fibrois-4 index (FIB-4) This index is based on age, platelet count, ALT level, and AST level. FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10^9/L) x √ALT (U/L)). A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of <1.45 indicates none to moderate fibrosis and an Index of >3.25 indicates advanced fibrosis. | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no Fibrois-4 index data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change in aspartate aminotransferase-to-platelet ratio index in Saroglitazar Magnesium groups as compared to the placebo group APRI was calculated as ([AST level/AST upper limit of normal]/ [Platelet count 1^09/L]) ×100, where AST is aspartate aminotransferase. The aspartate transaminase to platelet ratio index (APRI) is used to assess the risk of liver fibrosis. Higher APRI score represents a higher risk of liver fibrosis | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no aspartate aminotransferase-to-platelet ratio index data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis | Change from baseline in Nonalcoholic fatty liver disease Fibrosis Score (NFS) The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. NFS was calculated using the following formula: NAFLD fibrosis score = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A decrease in NFS score represents a positive outcome. An NFS score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis. | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no Nonalcoholic fatty liver disease Fibrosis Score data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Liver Enzyme | Change from baseline in liver enzyme parameters (ALT and AST) | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no liver enzyme parameters (ALT and AST) data for this outcome measure were analyzed. No further data analysis for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Lipid Profile | Change from baseline in triglyceride [TG), high-density lipoprotein [HDL], low-density lipoprotein [LDL], very low-density lipoprotein [VLDL], total cholesterol, and non-HDL cholesterol](streamdown:incomplete-link) | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no lipid profile (triglyceride, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, total cholesterol, non-HDL cholesterol) data for this outcome measure were analyzed. No further data analysis for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Fasting Glucose | Change from baseline in fasting plasma glucose (FPG) | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no fasting plasma glucose data for this outcome measure were analyzed. No further data analysis for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements. | Change from baseline in body weight | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no body weight data for this outcome measure were analyzed. No further data analysis for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements. | Change from baseline in BMI | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no BMI data for this outcome measure were analyzed. No further data analysis for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
|
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| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements. | Change from baseline in hip circumference and minimum waist circumference | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no hip circumference and minimum waist circumference data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT |
| |||||||||||||||||||||||
| Secondary | To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Health-related Quality of Life Scores Measured by Short Form-36 (SF-36) Questionnaire. | Change from baseline in SF-36 Questionnaire mental (MCS) and physical components scores (PCS). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as the worst health status. | The study was prematurely terminated after the enrollment of 4 participants. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. Consequently, no SF-36 Questionnaire mental (MCS) and physical components scores (PCS) data for this outcome measure were collected or analyzed. No further data collection for this specific efficacy outcome is anticipated. | Posted | Week 24/EOT. |
| |||||||||||||||||||||||
| Other Pre-specified | Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium Compared to Placebo | Number of Participants with Adverse Events. We have included data for Treatment emergent adverse events (TEAEs) only. TEAEs are those AEs that occur after administration of the study drug. | The study was prematurely terminated in 29/Sep/2024 by then only 4 participants were enrolled as per V3.0 of the protocol. Due to this early termination, none of the participants reached the End of Treatment (EOT) assessment. The safety data collected was restricted to what was available up to their early discontinuation and from the safety population. | Posted | Count of Participants | Participants | From baseline to Week 28 |
|
From Baseline to Week 28
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 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks) Saroglitazar Magnesium 4 mg: Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks). | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Placebo Arm | Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). Placebo: Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). | 0 | 1 | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Deven Parmar | Zydus Therapeutics Inc. | 7324050886 | dparmar@zydustherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2024 | Mar 27, 2025 | 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 |
|---|---|
| C000588741 | saroglitazar |
Not provided
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks).
Placebo: Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks).
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| OG001 | Placebo Arm | Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). Placebo: Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). |
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