Study Stopped
Management decision to suspend the study due to recruitment issues
Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm, 12-week Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 1, 2 and 4 mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
1 other identifier
interventional
124
1 country
33
Brief Summary
To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2017
Longer than P75 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedStudy Start
First participant enrolled
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFebruary 8, 2023
February 1, 2023
6.7 years
March 24, 2017
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change in triglyceride cholesterol levels
Percentage change in triglyceride cholesterol levels from baseline to Week 12.
12 Weeks
Secondary Outcomes (2)
Percentage change in TG-C
8 Weeks
Percentage change in lipid profile.
12 Weeks
Study Arms (4)
Saroglitazar magnesium 1 mg
EXPERIMENTALSaroglitazar magnesium 1 mg tablet orally once a day for 12 weeks
Saroglitazar magnesium 2 mg
EXPERIMENTALSaroglitazar magnesium 2 mg tablet orally once a day for 12 weeks
Saroglitazar magnesium 4 mg
EXPERIMENTALSaroglitazar magnesium 4 mg tablet orally once a day for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo tablet orally once a day for 12 weeks
Interventions
Randomly assigned patients will receive saroglitazar magnesium 1 mg orally once each morning before breakfast for 12 weeks
Randomly assigned patients will receive saroglitazar magnesium 2 mg orally once each morning before breakfast for 12 weeks
Randomly assigned patients will receive saroglitazar magnesium 4 mg orally once each morning before breakfast for 12 weeks
Randomly assigned patients will receive placebo orally once each morning before breakfast for 12 weeks
Eligibility Criteria
You may qualify if:
- Adults subjects (≥18 year) of either gender.
- Average fasting TG-C ≥500 mg/dL and ≤1500 mg/dL (from Visits 2 and 2.1).
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
You may not qualify if:
- History of pancreatitis within 6 months of the initial screening visit (Visit 1); patients that have an episode of pancreatitis after Visit 1 but before randomization will not be randomized.
- Patients with any history of pancreatitis may not be on GLP-1 agonists, DPP-4 inhibitors or pramlintide, with their last dose no sooner than 3 months prior to Visit 1; use of these agents by this population is prohibited throughout the duration of the trial and follow-up period. \[Patients without a history of pancreatitis on these agents must be on a stable dose as of 3 months prior to Visit 1.\]
- History of \>5% weight gain or weight loss or participation in weight gain/loss program in past 3 months and not in the maintenance phase as of Visit 1.
- Diabetic (as per ADA guideline) patients with HbA1c \>9.5 %.
- Patients on prandial/rapid acting insulin, thiazolidinediones (TZDs) or glitazars in the 3 months prior to Visit 1.
- Patients on unstable doses of basal insulin (i.e., glargine, detemir, NPH) with unstable defined as a greater than 20% fluctuation in daily dose within the past 3 months.
- Patients on anti-obesity medications within 6 months of Visit 1 (orlistat, lorcaserin, phentermine, naltrexone/bupropion etc.).
- Patients on drugs that may promote weight loss (i.e., anti-epileptic agents such as topiramate, zonisamide and the anti-depressant bupropion) may not be taken, unless the dose is stable for 3 months and the indication for use is not weight loss.
- Patients on prohibited nutraceutical supplements contained in Annexure 1 that are unwilling to wash-out starting at Visit 1 (and abstain from use throughout the duration of the study, including follow-up).
- Patients with unexplained hematuria prior to or first noted during Visit 1.
- Patients with anemia who are undergoing repletion of deficiencies (iron, folate, B12) not in the maintenance phase as of Visit 1.
- Patients on concomitant lipid-lowering medications and not willing to participate in Lead-in/Run-in Phase (Please refer Lead-in/Run-in Phase).
- Patients having heart failure of NYHA class (III-IV), unstable angina, acute myocardial infarction, stroke, transient ischaemic attack, any coronary revascularisation procedure and hospitalization for acute coronary syndrome and discharge within 6 months prior to screening.
- Patients with Left Ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) \<40%, as measured through ECHO).
- Uncontrolled hypertension (SBP \>160 and/or DBP\>100).
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Encompass Clinical Research
Encinitas, California, 92023, United States
Integrated Research Center
San Diego, California, 92117, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Colorado Springs Health Partners
Colorado Springs, Colorado, 80906, United States
Meridien Research - Bradenton
Bradenton, Florida, 34201, United States
Meridien Research - Lakeland
Lakeland, Florida, 33805, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Meridien Research - Tampa
Tampa, Florida, 33634, United States
River Birch Research Alliance LLC
Blue Ridge, Georgia, 30513, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Herman Clinical Research, LLC
Suwanee, Georgia, 30024, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Einstein Clinical Research
Charlotte, North Carolina, 28277, United States
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45227, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45246, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Ohio Clinical Research - Lyndhurst
Lyndhurst, Ohio, 44124, United States
Awasty Research Network, LLC
Marion, Ohio, 43302, United States
Ohio Clinical Research, LLC - Willoughby Hills
Willoughby Hills, Ohio, 44094, United States
Columbia Research Group, Inc.
Portland, Oregon, 97239, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620, United States
Jackson Clinic
Jackson, Tennessee, 38301, United States
Pioneer Research Solutions Inc.
Houston, Texas, 77099, United States
National Clinical Research - Richmond, Inc
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Deven V Parmar, MD
Zydus Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2017
First Posted
March 31, 2017
Study Start
April 6, 2017
Primary Completion
December 1, 2023
Study Completion
January 1, 2024
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
See above.