AzTrials
AzTrials

HypertriglyceridemiaPhase 3NCT04239950

Efficacy of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia

A Phase 3 study testing Ethyl Icosapentate in people with Hypertriglyceridemia, run by Mochida Pharmaceutical Company, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Hypertriglyceridemia
What is being tested?
Ethyl Icosapentate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
316 participants
Where
1 siteChina
Study dates
9 May 2020to 20 Jul 2023
Phase
Phase 3
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 35Show fewer
  • 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)
  • Patients with clinically significant bleeding tendency (e.g., menorrhagia, frequent epistaxis)
  • Patients with, or with a history of, severe trauma
  • Patients with a history of surgery requiring blood transfusion
  • Patients who have taken any EPA product
  • Patients who have received a PCSK9 (human proprotein convertase subtilisin/kexin type 9) inhibitor to treat hyperlipidemia
  • Patients who have taken antihyperlipidemic drugs within the last 4 weeks
  • Pregnant, possibly pregnant, or lactating women
  • Patients with a history of hypersensitivity to polyunsaturated fatty acids or gelatin
  • Patients with, or with a history of, malignant tumor
  • Patients with any serious disease, including hepatic, renal, hematologic, respiratory, GI, cardiovascular, psychological, neurologic, metabolic, and electrolyte disorders, or hypersensitivity
  • Patients who have received any other investigational drug within the last 3 months
  • Patients who are judged by the principal (or sub-) investigator to be ineligible as a study subject for any other reason
  • Patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg at Visit 2 (Week -2))
  • Patients who have changed the dosage of antidiabetic drug (except insulin) or who have switched from one drug to another since Visit 1 (Week -4)
  • Patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg at Visit 3 (Week -1)
  • Patients with an HbA1c level of ≥8.0% at Visit 2 (Week -2)
  • Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 2 (Week -2)
  • Patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg at Visit 4 (Week 0)
  • Patients with an HbA1c level of ≥8.0% at Visit 3 (Week -1)
  • Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 3 (Week -1)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Mochida Investigational sites

    Changsha

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia

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

Being tested
Placebo, Ethyl Icosapentate
Medical subject headings
Hypertriglyceridemia

What participants receive

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

  • PlaceboDrug

    Placebo

  • Ethyl IcosapentateDrug

    Ethyl Icosapentate

Study groups in NCT04239950
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo, orally, twice daily after breakfast and dinner for 12 weeks.
Receives: Drug: Placebo
Ethyl Icosapentate 1.8gExperimentalEthyl Icosapentate 0.9g, orally, twice daily after breakfast and dinner for 12 weeks.
Receives: Drug: Ethyl Icosapentate
Ethyl Icosapentate 3.6gExperimentalEthyl Icosapentate 1.8g, orally, twice daily after breakfast and dinner for 12 weeks.
Receives: Drug: Ethyl Icosapentate

What is being measured

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

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

    Measured: Baseline and 12 weeks

  2. Adverse events after the start of study drug administration

    Measured: 12 weeks

Secondary outcomes (4)

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

    Measured: Baseline and 12 weeks

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

    Measured: Baseline and 12 weeks

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

    Measured: Baseline and 12 weeks

  4. Adverse drug reaction after the start of study drug administration

    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 posted27 Jan 2020
  2. Study start9 May 2020
  3. Primary completion20 Jul 2023
  4. Study completion20 Jul 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04239950
Sponsor's protocol ID
MND2112H33
Other IDs
20191474
Status last verified
Jul 2024
First submitted
20 Jan 2020
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Feb;20(2):289-298. doi: 10.1016/j.jacl.2025.12.007. Epub 2025 Dec 14.

    PubMed 41500861

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ethyl Icosapentate in people with Hypertriglyceridemia, run by Mochida Pharmaceutical Company, Ltd. at 1 site in China.

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 8 inclusion and 35 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: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04239950, which also lists 1 linked publication.

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 15 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in