Trial Outcomes & Findings for Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US (NCT NCT05211284)
NCT ID: NCT05211284
Last Updated: 2025-09-02
Results Overview
Change from baseline in hepatic fat content
TERMINATED
PHASE2
4 participants
Week 24/EOT
2025-09-02
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Study Terminated
|
3
|
1
|
Baseline Characteristics
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
Baseline characteristics by cohort
| Measure |
Saroglitazar Magnesium 4 mg
n=3 Participants
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).
|
Placebo Arm
n=1 Participants
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).
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24/EOTPopulation: 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
Change from baseline in hepatic fat content
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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
Proportion of participants with reduction of at least 30% in hepatic fat content from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in Liver Stiffness Measurement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in Continuous Controlled Attenuation Parameter
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in Fibroscan-aspartate aminotransferase (FAST) score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in plasma pro-collagen type 3 (PRO-C3) levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in liver enzyme parameters (ALT and AST)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in fasting plasma glucose (FPG)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in body weight
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in BMI
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOTPopulation: 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.
Change from baseline in hip circumference and minimum waist circumference
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24/EOT.Population: 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.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 28Population: 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.
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=3 Participants
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).
|
Placebo Arm
n=1 Participants
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).
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium Compared to Placebo
|
0 Participants
|
0 Participants
|
Adverse Events
Saroglitazar Magnesium 4 mg
Placebo Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saroglitazar Magnesium 4 mg
n=3 participants at risk
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).
|
Placebo Arm
n=1 participants at risk
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).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory tract Infection
|
0.00%
0/3 • From Baseline to Week 28
|
100.0%
1/1 • Number of events 1 • From Baseline to Week 28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place