Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL

Paused · Phase 2 · Has a placebo group

Conditions studied: Dyslipidemias

In brief

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.

Key facts

Study ID

NCT03097107

Run by

Zydus Therapeutics Inc.

People needed

124

Starts

2017-04-06

Expected to finish

2024-01-01

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• An uncontrolled thyroid disorder
• Uncontrolled hyperthyroidism is defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine (RAI) and/or surgery -or- that has been treated with RAI and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or proplythiouracil) within 6 months of Visit 1.
• Uncontrolled hypothyroidism is defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy within 3 months of Visit 1.
• History of GI malabsorption or history of gastric bypass, banding, or diversional bariatric surgery.
• History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT ≥2 times of upper normal limit (UNL) or bilirubin ≥1.5 times UNL at Visit 1.
• History of myopathies or evidence of active muscle diseases demonstrated by CPK ≥5 times UNL at Visit 1.
• History of any other concurrent serious illness or malignancy (except successfully treated basal and squamous cell carcinoma of the skin), within the past 5 years (e.g. tuberculosis, HIV).
• Positive HIV, hepatitis A (positivity of IgM), hepatitis B, or hepatitis C at Visit 1.
• History of excessive consumption of alcoholic beverages (consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking). For the remainder of the study, patients should agree to refrain from excessive alcohol consumption (i.e., >2 alcoholic beverages per day), to maintain their current dietary regimen, and to not alter their normal activity routines. (Note: patients should not drink alcohol for at least 24 hrs prior to any site visit).
• History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.

Where it is running

• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• Encompass Clinical Research — Encinitas, California, United States
• Integrated Research Center — San Diego, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Colorado Springs Health Partners — Colorado Springs, Colorado, United States
• Meridien Research - Bradenton — Bradenton, Florida, United States
• Meridien Research - Lakeland — Lakeland, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• Meridien Research - Tampa — Tampa, Florida, United States
• River Birch Research Alliance LLC — Blue Ridge, Georgia, United States
• Drug Studies America — Marietta, Georgia, United States
• Herman Clinical Research, LLC — Suwanee, Georgia, United States
• Cedar-Crosse Research Center — Chicago, Illinois, United States
• Heartland Research Associates, LLC — Newton, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• MD Medical Research — Oxon Hill, Maryland, United States
• Mercury Street Medical — Butte, Montana, United States
• Einstein Clinical Research — Charlotte, North Carolina, United States
• Triad Clinical Trials LLC — Greensboro, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Metabolic and Atherosclerosis Research Center — Cincinnati, Ohio, United States
• Sterling Research Group, Ltd. — Cincinnati, Ohio, United States
• Wells Institute for Health Awareness — Kettering, Ohio, United States

Full record on ClinicalTrials.gov

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