Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type2 Diabetes, Dyslipidemia

In brief

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: * nonfatal Myocardial Infarction (MI) * nonfatal ischemic stroke * coronary revascularization; or * Cardio Vascular (CV) death.

Key facts

Study ID

NCT03071692

Run by

Kowa Research Institute, Inc.

People needed

10544

Starts

2017-03-23

Expected to finish

2022-07-27

Last updated by the study team

2025-09-25

Who can join

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

You may qualify if…

• Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
• HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
• Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ≥ 126 mg/dL [7.0 mmol/L], 2-hour ≥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either
• Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
• Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:
• i. Prior MI or ischemic (non-hemorrhagic) stroke
• ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
• iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
• iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis
• v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing [eg, toe-brachial index, angiogram, or other imaging study])
• vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)

You may not qualify if…

• Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
• Known sensitivity to PPAR-α agonists or tablet excipients
• Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin > 100 mg/day or dietary supplements or prescription omega-3 fatty acids > 1 g/day
• Type 1 diabetes mellitus

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• VA Medical Center - Birmingham — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Fundamental Research, LLC — Gulf Shores, Alabama, United States
• Mobile Heart Specialists, PC — Mobile, Alabama, United States
• Terence T. Hart, MD — Tuscumbia, Alabama, United States
• Synexus Clinical Research US, Inc. — Chandler, Arizona, United States
• Synexus Clinical Research US, Inc. — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Peoria, Arizona, United States
• Phoenix Veterans Adminstration Health Care System — Phoenix, Arizona, United States
• Synexus Clinical Research US, Inc. — Phoenix, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Surprise, Arizona, United States
• Synexus Clinical Research US, Inc. — Tucson, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• Clinical Research Alliance, Inc — Alhambra, California, United States
• Aurora Care Clinic — Costa Mesa, California, United States
• AMCR Institute, Inc. — Escondido, California, United States
• National Institute of Clinical Research — Huntington Beach, California, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Eastside Clinical Research Associates — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Richard S. Cherlin, MD — Los Gatos, California, United States
• Synexus Clinical Research US, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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