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PPAR Agonist
Saroglitazar for NAFLD in PCOS
Verified 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
Are you a female of the age 18-45 years old?
Have you been diagnosed with Non-Alcoholic Steatohepatitis (NASH) or Fatty Liver Disease?
Must not have
Have you had weight loss surgery (including bypass or sleeve surgery)?
Have you been diagnosed with any of the following medical conditions often associated with a PCOS diagnosis: *large waist size (overweight/obesity) *high cholesterol *high triglycerides *high blood pressure *Type 2 Diabetes/Prediabetes ?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights
Study Summary
This trial is testing if a new drug, Saroglitazar Magnesium, is effective and safe for women with PCOS.
Who is the study for?
This trial is for women aged 18-45 with PCOS and Non-Alcoholic Fatty Liver Disease or NASH. Participants should not be pregnant, nursing, or have had weight loss surgery. They also shouldn't have related conditions like obesity, high cholesterol, triglycerides, blood pressure, or Type 2 Diabetes.Check my eligibility
What is being tested?
The study tests Saroglitazar Magnesium's effectiveness and safety in treating NAFLD in women with PCOS compared to a placebo. It's a phase 2A trial where participants are randomly assigned to either the drug or placebo without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects of Saroglitazar Magnesium aren't listed here, common ones may include headache, fatigue, nausea, and potential liver-related issues due to its action on liver fat metabolism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 18 and 45.
Select...
I have been diagnosed with NASH or Fatty Liver Disease.
Select...
I have been diagnosed with PCOS.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had weight loss surgery.
Select...
I have been diagnosed with conditions related to PCOS, such as obesity or high blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hepatic fat content
Secondary outcome measures
Accumulation index calculated as a ratio of AUCtau (last dose)/AUCtau (first dose) (For Multiple Dose)
Apparent Clearance [CL/F,ss] (For Multiple Dose)
Apparent Clearance [CL/F] (For Single Dose)
+30 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Saroglitazar Magnesium 4 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium once daily in the morning before breakfast
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet once daily in the morning before breakfast
Find a Location
Who is running the clinical trial?
Zydus Therapeutics Inc.Lead Sponsor
13 Previous Clinical Trials
1,111 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
542 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Deven Parmar, MDStudy DirectorZydus Therapeutics Inc.
2 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with NASH or Fatty Liver Disease.I have been diagnosed with PCOS.I am a woman aged between 18 and 45.I have been diagnosed with conditions related to PCOS, such as obesity or high blood pressure.I have had weight loss surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Saroglitazar Magnesium 4 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT03617263 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the United States Food and Drug Administration sanctioned Saroglitazar Magnesium 4 mg Tablet?
"After careful assessment, Saroglitazar Magnesium 4 mg Tablet was deemed to be 2 out of 3 on the safety scale due to limited clinical data indicating its efficacy."
Answered by AI
What is the total count of clinical centers currently conducting this research?
"Currently, this experiment is recruiting from 9 different sites. These include Miami, Aurora and Indianapolis along with 6 other cities. To minimise travel demands it would be ideal to choose the nearest location if you decide to sign up for the trial."
Answered by AI
What criteria are required of individuals to be eligible participants in the clinical trial?
"Qualification for this research requires having fatty liver disease and being between 18-45 years old. At present, 90 individuals are targeted to join the trial."
Answered by AI
Is enrollment in this trial still open?
"Affirmative, according to clinicaltrials.gov the trial, which was initially published on December 4th 2018, is still recruiting participants. A total of 90 volunteers are needed from 9 different locations for this investigation."
Answered by AI
Is this research study enrolling participants who are over twenty years of age?
"All subjects hoping to be enrolled in this trial must have reached 18 years of age, but should not exceed 45."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Alabama
California
What site did they apply to?
University of California, San Francisco
Dr.Melanie Cree Green
Other
Dr.Robert Allen Jenders
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0
Why did patients apply to this trial?
I want to be healthy. To help with research. I am interested in the study.
PatientReceived no prior treatments
Find out more about my liver. I wanted to control my symptoms.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the study? How long is this study?? How many visits to the doctor are involved? How long does each visit take?
PatientReceived no prior treatments
How long is the screening visits how often do i have to come in? Will i have transportation to and from the clinical site?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Dr.Robert Allen Jenders: < 24 hours
- University of California, San Francisco: < 48 hours
Average response time
- < 2 Days
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