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DyslipidemiasPhase 2NCT03097107

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

A Phase 2 study testing Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg in people with Dyslipidemias, run by Zydus Therapeutics Inc. at 33 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyslipidemias
What is being tested?
Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
33 sitesUnited States
Study dates
6 Apr 2017to Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 33Show fewer
  • 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.
  • Renal dysfunction demonstrated by abnormal eGFR <50 mL/min/1.73 m2.
  • History of clinically significant* systemic steroid therapy (intramuscular, intravenous, intra-articular, or oral route) within 3 months of the Visit 1 or anticipated requirement for systemic steroid therapy at Visit 1(however, topical, ophthalmic and inhaled steroids are allowed).
  • Clinically significant' (i.e., no more than 5 days of systemic steroids treatment within 3 months of Visit 1)
  • NSAID use in excess of a reasonably prescribed dose and/or use in individuals with a history of complications resulting from these agents.
  • Participation in any other clinical trial in the past 3 months in which investigational product was taken and/or a medical device was utilized. Patients that were screened but not randomized for another study must wait 30 days to participate in Visit 1.
  • Pregnancy (including a positive urine and serum pregnancy test at Visit 1), lactation or planned pregnancy/lactation during any time during the lead-in, study or follow-up periods.
  • Patients on hormonal contraception or hormone replacement therapy containing estrogen (progesterone based contraception and testosterone replacement therapy are permitted granted that dosing is stable for at least 3 months prior to Visit 1).
  • Women of childbearing potential (WOCBP) and men, UNLESS using effective contraceptive methods, such as an intra-uterine device or other mechanical contraception method with condom or diaphragm and spermicide) throughout the study. For male patients, contraception measures (condom and spermicide) must be taken during the study, either by the male participant or his female partner. (Note: Enrolled females otherwise must be surgically sterilize for at least the 6 months preceding Visit 1 or postmenopausal, defined as 12 months with no menses without an alternative medical cause).

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • River Birch Research Alliance LLC

    Blue Ridge, Georgia, 30513

  • Meridien Research - Bradenton

    Bradenton, Florida, 34201

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • Mercury Street Medical

    Butte, Montana, 59701

  • Einstein Clinical Research

    Charlotte, North Carolina, 28277

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Metabolic and Atherosclerosis Research Center

    Cincinnati, Ohio, 45227

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45246

  • Colorado Springs Health Partners

    Colorado Springs, Colorado, 80906

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Encompass Clinical Research

    Encinitas, California, 92023

  • Triad Clinical Trials LLC

    Greensboro, North Carolina, 27410

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • Jackson Clinic

    Jackson, Tennessee, 38301

  • Wells Institute for Health Awareness

    Kettering, Ohio, 45429

  • Meridien Research - Lakeland

    Lakeland, Florida, 33805

  • Ohio Clinical Research - Lyndhurst

    Lyndhurst, Ohio, 44124

  • Drug Studies America

    Marietta, Georgia, 30060

  • Awasty Research Network, LLC

    Marion, Ohio, 43302

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Columbia Research Group, Inc.

    Portland, Oregon, 97239

  • National Clinical Research - Richmond, Inc

    Richmond, Virginia, 23294

  • Integrated Research Center

    San Diego, California, 92117

  • Herman Clinical Research, LLC

    Suwanee, Georgia, 30024

  • Meridien Research - Tampa

    Tampa, Florida, 33634

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Ohio Clinical Research, LLC - Willoughby Hills

    Willoughby Hills, Ohio, 44094

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

SARO.15.001.04 is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel arm, 12-week study designed 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.

A total 124 subjects will be enrolled in a ratio of 1:1:1:1 to receive either Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, or placebo.

Conditions
Dyslipidemias
Being tested
Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, Placebo
Keywords
hypertriglyceridemia, dyslipidemia, saroglitazar magnesium, lipid disorder
Medical subject headings
Dyslipidemias, Hypertriglyceridemia, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saroglitazar Magnesium 1 mgDrug

    Randomly assigned patients will receive saroglitazar magnesium 1 mg orally once each morning before breakfast for 12 weeks

  • Saroglitazar Magnesium 2 mgDrug

    Randomly assigned patients will receive saroglitazar magnesium 2 mg orally once each morning before breakfast for 12 weeks

  • Saroglitazar Magnesium 4 mgDrug

    Randomly assigned patients will receive saroglitazar magnesium 4 mg orally once each morning before breakfast for 12 weeks

  • PlaceboDrug

    Randomly assigned patients will receive placebo orally once each morning before breakfast for 12 weeks

Study groups in NCT03097107
Study groupRoleWhat they receive
Saroglitazar magnesium 1 mgExperimentalSaroglitazar magnesium 1 mg tablet orally once a day for 12 weeks
Receives: Drug: Saroglitazar Magnesium 1 mg
Saroglitazar magnesium 2 mgExperimentalSaroglitazar magnesium 2 mg tablet orally once a day for 12 weeks
Receives: Drug: Saroglitazar Magnesium 2 mg
Saroglitazar magnesium 4 mgExperimentalSaroglitazar magnesium 4 mg tablet orally once a day for 12 weeks
Receives: Drug: Saroglitazar Magnesium 4 mg
PlaceboPlacebo comparatorPlacebo tablet orally once a day for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in triglyceride cholesterol levels

    Percentage change in triglyceride cholesterol levels from baseline to Week 12.

    Measured: 12 Weeks

Secondary outcomes (2)

  1. Percentage change in TG-C

    Percentage change from baseline to Week 4 and 8 in TG-C

    Measured: 8 Weeks

  2. Percentage change in lipid profile.

    Percentage change from baseline to 12 in lipid profile.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2017
  2. Study start6 Apr 2017
  3. Primary completionDec 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Management decision to suspend the study due to recruitment issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03097107
Sponsor's protocol ID
SARO.15.001.05
Status last verified
Feb 2023
First submitted
24 Mar 2017
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: See above.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg in people with Dyslipidemias, run by Zydus Therapeutics Inc. at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in triglyceride cholesterol levels (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03097107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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