Trial Outcomes & Findings for Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis (NCT NCT03863574)
NCT ID: NCT03863574
Last Updated: 2024-10-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
3
|
|
Overall Study
COMPLETED
|
6
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.67 Years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
50.57 Years
STANDARD_DEVIATION 16.48 • n=7 Participants
|
63.33 Years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
52.25 Years
STANDARD_DEVIATION 13.46 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Body Mass Index
|
37.32 kg/m^2
STANDARD_DEVIATION 5.85 • n=5 Participants
|
37.89 kg/m^2
STANDARD_DEVIATION 8.27 • n=7 Participants
|
37.67 kg/m^2
STANDARD_DEVIATION 12.76 • n=5 Participants
|
37.63 kg/m^2
STANDARD_DEVIATION 7.78 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: modified intention-to-treat
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
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
NAS Score (Nonalcoholic Fatty Liver Disease [NAFLD] Activity Score)
|
-1.50 units on a scale
Standard Deviation 0.84
|
-1.86 units on a scale
Standard Deviation 1.57
|
-1.33 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
To Evaluate the Percentage of Responders in the Treatment Groups.
|
4 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
Percentage of responders defined by the disappearance of steatohepatitis
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Percentage of Responders Defined by the Disappearance of Steatohepatitis.
|
5 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
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
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Stage of Steatosis, Lobular Inflammation and Ballooning.
Changes in the stage of steatosis
|
-0.50 units on a scale
Standard Deviation 0.55
|
-0.71 units on a scale
Standard Deviation 0.76
|
-0.33 units on a scale
Standard Deviation 0.58
|
|
Changes in the Stage of Steatosis, Lobular Inflammation and Ballooning.
Changes in the stage of lobular inflammation
|
-0.17 units on a scale
Standard Deviation 0.41
|
-0.29 units on a scale
Standard Deviation 0.49
|
-0.67 units on a scale
Standard Deviation 0.58
|
|
Changes in the Stage of Steatosis, Lobular Inflammation and Ballooning.
Changes in the stage of ballooning
|
-0.83 units on a scale
Standard Deviation 0.41
|
-0.86 units on a scale
Standard Deviation 0.90
|
-0.33 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified intent-to-treat population
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
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Stage of Fibrosis.
|
-0.50 units on a scale
Standard Deviation 0.84
|
-0.43 units on a scale
Standard Deviation 0.79
|
0.33 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified intent-to-treat population
Liver function tests include ALT, AST, ALP, GGT
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Liver Function Tests; (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Alkaline Phosphatases [ALP], and Gamma-glutamyl Transferase [GGT]).
Change in ALT
|
-22.83 U/L
Standard Deviation 14.29
|
-29.57 U/L
Standard Deviation 26.76
|
-14.67 U/L
Standard Deviation 48.95
|
|
Changes in the Liver Function Tests; (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Alkaline Phosphatases [ALP], and Gamma-glutamyl Transferase [GGT]).
Change in AST
|
-10.33 U/L
Standard Deviation 5.32
|
-16.29 U/L
Standard Deviation 11.63
|
-19.33 U/L
Standard Deviation 47.44
|
|
Changes in the Liver Function Tests; (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Alkaline Phosphatases [ALP], and Gamma-glutamyl Transferase [GGT]).
Change in ALP
|
-24.00 U/L
Standard Deviation 9.92
|
-23.86 U/L
Standard Deviation 15.18
|
3.67 U/L
Standard Deviation 5.13
|
|
Changes in the Liver Function Tests; (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Alkaline Phosphatases [ALP], and Gamma-glutamyl Transferase [GGT]).
Change in GGT
|
-23.83 U/L
Standard Deviation 18.55
|
-28.43 U/L
Standard Deviation 33.30
|
-1.67 U/L
Standard Deviation 19.50
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified intend-to-treat population
Changes in albumin and total protein
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Liver Function Tests; Albumin and Total Protein
Change in albumin
|
-0.05 g/dL
Standard Deviation 0.22
|
-0.04 g/dL
Standard Deviation 0.17
|
0.13 g/dL
Standard Deviation 0.12
|
|
Changes in the Liver Function Tests; Albumin and Total Protein
Change in total protein
|
-0.08 g/dL
Standard Deviation 0.40
|
0.09 g/dL
Standard Deviation 0.41
|
0.27 g/dL
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified intent-to-treat population
Change in direct bilirubin
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Liver Function Tests; Direct Bilirubin
|
-0.01 mg/dL
Standard Deviation 0.03
|
-0.01 mg/dL
Standard Deviation 0.02
|
-0.00 mg/dL
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified intent-to-treat population
Evaluation of Lipid profile parameters
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Lipid Profile.
Change in Triglyceride
|
-40.33 mg/dL
Standard Deviation 38.37
|
-16.71 mg/dL
Standard Deviation 44.31
|
-6.00 mg/dL
Standard Deviation 34.04
|
|
Changes in the Lipid Profile.
Change in Total Cholesterol
|
11.17 mg/dL
Standard Deviation 40.45
|
-16.00 mg/dL
Standard Deviation 31.12
|
-0.33 mg/dL
Standard Deviation 9.02
|
|
Changes in the Lipid Profile.
Change in Small dense LDL
|
1.27 mg/dL
Standard Deviation 15.99
|
-9.29 mg/dL
Standard Deviation 11.85
|
5.87 mg/dL
Standard Deviation 6.66
|
|
Changes in the Lipid Profile.
Change in High-density Lipoprotein
|
6.33 mg/dL
Standard Deviation 14.85
|
-0.14 mg/dL
Standard Deviation 8.47
|
7.00 mg/dL
Standard Deviation 4.36
|
|
Changes in the Lipid Profile.
Change in Low-density lipoprotein
|
13.00 mg/dL
Standard Deviation 34.89
|
-12.57 mg/dL
Standard Deviation 28.11
|
-6.00 mg/dL
Standard Deviation 5.29
|
|
Changes in the Lipid Profile.
Change in Very low-density lipoprotein
|
-8.17 mg/dL
Standard Deviation 7.41
|
-3.29 mg/dL
Standard Deviation 8.88
|
-1.33 mg/dL
Standard Deviation 6.51
|
|
Changes in the Lipid Profile.
Change in non-HDL Cholesterol
|
4.83 mg/dL
Standard Deviation 33.68
|
-15.86 mg/dL
Standard Deviation 29.23
|
-7.33 mg/dL
Standard Deviation 9.29
|
|
Changes in the Lipid Profile.
Change in Apo lipoprotein A1
|
10.50 mg/dL
Standard Deviation 36.74
|
-14.29 mg/dL
Standard Deviation 26.98
|
7.33 mg/dL
Standard Deviation 2.08
|
|
Changes in the Lipid Profile.
Change in Apo lipoprotein B
|
1.00 mg/dL
Standard Deviation 26.53
|
-14.71 mg/dL
Standard Deviation 21.04
|
-1.33 mg/dL
Standard Deviation 4.62
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
Number of Participants with Adverse Events.
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium 2 mg and 4 mg
|
3 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
Evaluation of Fasting Plasma Glucose
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance; Fasting Plasma Glucose
|
2.67 mg/dL
Standard Deviation 19.18
|
-0.86 mg/dL
Standard Deviation 41.10
|
7.67 mg/dL
Standard Deviation 12.50
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
Evaluation of Hemoglobin A1c
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance; Hemoglobin A1c
|
-0.52 percentage of HbA1c
Standard Deviation 0.65
|
-0.09 percentage of HbA1c
Standard Deviation 0.28
|
0.03 percentage of HbA1c
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
Evaluation of Insulin
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance; Insulin
|
-1.05 μIU/mL
Standard Deviation 20.05
|
6.74 μIU/mL
Standard Deviation 15.34
|
8.13 μIU/mL
Standard Deviation 12.32
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
Evaluation of C-peptide
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance: C-peptide
|
-1.09 ng/mL
Standard Deviation 2.26
|
0.08 ng/mL
Standard Deviation 1.41
|
0.27 ng/mL
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance: Homeostasis Model Assessment of Beta Cell Function (HOMA -β)
|
-34.35 percentage of HOMA of Beta Cell Function
Standard Deviation 84.41
|
14.49 percentage of HOMA of Beta Cell Function
Standard Deviation 358.04
|
30.10 percentage of HOMA of Beta Cell Function
Standard Deviation 46.15
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance: HOMA of Insulin Resistance
|
0.45 percentage of HOMA of Insulin Resistance
Standard Deviation 8.30
|
2.73 percentage of HOMA of Insulin Resistance
Standard Deviation 5.77
|
2.34 percentage of HOMA of Insulin Resistance
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: modified intent-to-treat population
Evaluation of Total Adiponectin
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=6 Participants
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.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|---|
|
Changes in the Glycemic Control and Insulin Resistance: Total Adiponectin
|
1.84 μg/mL
Standard Deviation 2.17
|
0.68 μg/mL
Standard Deviation 3.28
|
1.50 μg/mL
Standard Deviation 4.02
|
Adverse Events
Saroglitazar Magnesium 2 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Saroglitazar Magnesium 4 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saroglitazar Magnesium 2 mg
n=6 participants at risk
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.
|
Saroglitazar Magnesium 4 mg
n=7 participants at risk
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.
|
Placebo
n=3 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
Other adverse events
| Measure |
Saroglitazar Magnesium 2 mg
n=6 participants at risk
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.
|
Saroglitazar Magnesium 4 mg
n=7 participants at risk
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.
|
Placebo
n=3 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/6 • 24 Weeks
|
28.6%
2/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Tooth abscess
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal mass
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Gastrointestinal disorders
Uvulitis
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Nervous system disorders
Akathisia
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Nervous system disorders
Dyskinesia
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
General disorders
Fatigue
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
33.3%
1/3 • 24 Weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Investigations
Weight increased
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/6 • 24 Weeks
|
14.3%
1/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6 • 24 Weeks
|
0.00%
0/7 • 24 Weeks
|
0.00%
0/3 • 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place