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PPAR Agonist

Saroglitazar Magnesium for Non-alcoholic Fatty Liver Disease in HIV (SARONAPLUS Trial)

Phase 2
Recruiting
Research Sponsored by Zydus Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (≥18 years of age) with documented HIV
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 72
Awards & highlights

SARONAPLUS Trial Summary

This trialstudies a drug to treat fatty liver in people living with HIV in the US.

Who is the study for?
Adults with HIV and confirmed NASH from a recent liver biopsy can join this trial. They must have controlled HIV for at least 6 months, be on stable antiretroviral therapy, and agree to an end-of-treatment liver biopsy. Excluded are those with severe liver conditions like cirrhosis, uncontrolled diabetes or hypertension, significant alcohol consumption history, certain medication use including PPAR agonists and CYP2C8 inhibitors/substrates, unstable heart disease or other serious health issues.Check my eligibility
What is being tested?
The trial is testing Saroglitazar Magnesium (4 mg) against a placebo in people living with HIV who have non-alcoholic steatohepatitis (NASH). Participants will randomly receive either the drug or a placebo to see if it helps improve their liver health.See study design
What are the potential side effects?
While specific side effects of Saroglitazar Magnesium aren't listed here, similar medications often cause digestive issues, potential changes in blood lipid levels, fatigue, allergic reactions and possibly affect blood sugar control.

SARONAPLUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult with confirmed HIV.

SARONAPLUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo in improving NASH, defined as an improvement of at least 2 points (without worsening of fibrosis) in the NAFLD activity score (NAS)
Secondary outcome measures
To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on body mass index (BMI)
To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on body weight
To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in 10-year Atherosclerotic cardiovascular disease (ASCVD) risk score (ACC/AHA Guideline on the Assessment of Cardiovascular Risk, 2013)
+8 more
Other outcome measures
Evaluate the safety and tolerability of Saroglitazar Magnesium 4 mg compared with Placebo
To assess the safety and tolerability of Saroglitazar Magnesium 4 mg compared with placebo
To evaluate the safety and tolerability of Saroglitazar Magnesium 4 mg compared with Placebo

SARONAPLUS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Saroglitazar Magnesium 4 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (72 weeks)
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (72 weeks).

Find a Location

Who is running the clinical trial?

Zydus Therapeutics Inc.Lead Sponsor
14 Previous Clinical Trials
1,191 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
472 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Deven V ParmarStudy DirectorZydus Therapeutics Inc.

Media Library

Saroglitazar Magnesium 4 mg (PPAR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05211284 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Saroglitazar Magnesium 4 mg, Placebo Arm
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Saroglitazar Magnesium 4 mg Highlights & Side Effects. Trial Name: NCT05211284 — Phase 2
Saroglitazar Magnesium 4 mg (PPAR Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211284 — Phase 2
~46 spots leftby Feb 2025
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