Efficacy of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia

NCT04239950 | Completed Phase 3

• 2 other identifiers: MND2112H3320191474
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ethyl icosapentate in Chinese patients with severe hypertriglyceridemia.

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (2)

• Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration

  Baseline and 12 weeks

• Adverse events after the start of study drug administration

  12 weeks

Secondary Outcomes (4)

• Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration

  Baseline and 12 weeks

• Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) level at 12 weeks after the start of study drug administration

  Baseline and 12 weeks

• Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration

  Baseline and 12 weeks

• Adverse drug reaction after the start of study drug administration

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo, orally, twice daily after breakfast and dinner for 12 weeks.

Drug: Placebo

Ethyl Icosapentate 1.8g

EXPERIMENTAL

Ethyl Icosapentate 0.9g, orally, twice daily after breakfast and dinner for 12 weeks.

Drug: Ethyl Icosapentate

Ethyl Icosapentate 3.6g

EXPERIMENTAL

Ethyl Icosapentate 1.8g, orally, twice daily after breakfast and dinner for 12 weeks.

Drug: Ethyl Icosapentate

Interventions

Placebo DRUG

Placebo

Placebo

Ethyl Icosapentate DRUG

Ethyl Icosapentate

Ethyl Icosapentate 1.8g; Ethyl Icosapentate 3.6g

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose serum Triglyceride (TG) level (fasting) from week -6 to week -4 is 500 mg/dL or higher and less than 2,000 mg/dL
• Patients who receive instructions for lifestyle improvement and are able to comply with all instructions throughout the study participation period
• Patients who are 18 to \< 75 years of age, regardless of sex, at the time of informed consent
• Patients who have provided written consent to participate in this clinical trial
• Patients whose serum TG level (fasting) is less than 2,000 mg/dL at Week -2
• Patients whose serum TG level (fasting) is less than 2,000 mg/dL at Week -1
• Patients in whom the average of Week -2 and Week -1 in serum TG level (fasting) is 500 mg/dL or higher and less than 2,000 mg/dL
• Outpatients

You may not qualify if:

• Patients whose HbA1c from week -6 to week -4 is 8.0% or higher
• Patients whose Alanine Aminotransferase (ALT) or Aspartate aminotransferase (AST) from week -6 to week -4 is more than 3 times the upper limit of normal
• Patients with, or with a history of, angina pectoris or myocardial infarction
• Patients with a history of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting
• Patients with familial lipoprotein lipase (LPL) deficiency, familial apolipoprotein C-II (apo C-II) deficiency, or familial type III, IV hyperlipidemia
• Patients with hypothyroidism, Cushing's syndrome, acromegaly, nephrotic syndrome, chronic renal failure, systemic lupus erythematosus, myeloma, or nonalcoholic steatohepatitis (NASH)
• Patients with hyperlipidemia induced by drugs (e.g., corticosteroids, beta-blockers, contraceptives, interferons, retinoids, and diuretics)
• Patients with, or with a history of, alcohol dependence or abuse or patients whose hyperlipidemia is presumed to be primarily caused by alcohol
• Patients with aortic aneurysm or who have undergone aortic aneurysmectomy within the last 6 months
• Patients with uncontrollable hypertension (patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg in a sitting position at Visit 1 (Week -4))
• Patients with, or with a history of, pancreatitis or patients suspected as pancreatitis by examination, etc
• Patients with a diagnosis of complication of pancreas or bile duct-related neoplastic disease
• Patients with type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy
• Patients with any of the following hemorrhagic findings within the last 6 months:
• Patients with, or with a history of, clinically significant hemorrhagic disease (e.g., cerebral hemorrhage, hemophilia, capillary fragility, gastrointestinal \[GI\] ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage)

Sponsors & Collaborators

• Mochida Pharmaceutical Company, Ltd.: lead
• Sumitomo Pharma (Suzhou) Co., Ltd.: collaborator

Study Sites (1)

Mochida Investigational sites

Changsha, China

Location

Related Publications (1)

• Wang Y, Long M, Chen F, Wu D, Pei Z, Wang X, Zhao W, Mori T, Zhao S. Efficacy and safety of highly purified ethyl icosapentate soft capsules (MND-21) for the treatment of severe hypertriglyceridemia: A 12-week, multi-center, placebo-controlled, randomized, double-blind, phase III clinical trial in China. J Clin Lipidol. 2025 Dec 14:S1933-2874(25)00539-2. doi: 10.1016/j.jacl.2025.12.007. Online ahead of print.

  PMID: 41500861 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

eicosapentaenoic acid ethanolamide

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Takuya Mori

  Mochida Pharmaceutical Company, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: January 20, 2020
• First Posted: January 27, 2020
• Study Start: May 9, 2020
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)