A Phase 3 interventional study of Placebo and Ethyl Icosapentate in Hypertriglyceridemia, sponsored by Mochida Pharmaceutical Company, Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 3, Interventional, and Treatment
Among 26 studies in Hypertriglyceridemia with a site in China — 14 open to participants now, 19 under way, 5 of them phase 3. Hypertriglyceridemia · China.
Among the 26 studies in Hypertriglyceridemia with a site in China, this one is the 9th largest by enrollment of the 25 interventional ones that give a count, is the only one that started in 2020, is one of 7 in phase 3, and was the 4th registered.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
Browse Hypertriglyceridemia studies →14 of the 26 studies in Hypertriglyceridemia with a site in China are open now. Recruiting first, the newest first:
General Hospital of Shenyang Military Region · Sites in China
Ages 18–75
Eli Lilly and Company · Sites in China, United States, Canada and 1 more country
Ages 18+
CorrectSequence Therapeutics Co., Ltd · Sites in China
Ages 18–55
Shanghai JMT-Bio Inc. · Sites in China
Ages 18–75
Arrowhead Pharmaceuticals · Sites in China, United States, Argentina and 24 more countries
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 22 Hypertriglyceridemia studies recruiting now, 9 (41%) set no upper age limit and 12 (55%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 74 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 6 · Phase 3 7 · Phase 4 4
First in 2011; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 316 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Median enrollment 119 across the 25 interventional studies, 250 across the 1 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 26 have an industry lead sponsor. The 10 most frequent:
Mochida Pharmaceutical Company, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Mochida Pharmaceutical Company, Ltd. has 3 studies filed under Hypertriglyceridemia — fewer than ten, so there is no comparison to draw.
8 of the studies in Hypertriglyceridemia with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07349615Phase 3Beijing Suncadia Pharmaceuticals Co., LtdA Study of SHR-1918 In Participants With Hypertriglyceridemia | 2027-03 |
| NCT07176923CorrectSequence Therapeutics Co., LtdCS-121 APOC3 Base Editing in FCS | 2026-12 |
| NCT07050134Junbo GeA Trial to Evaluate the Efficacy and Safety of DR10624 in Patients With Hypertriglyceridemia and Carotid Atherosclerotic Plaque | 2026-12-31 |
| NCT07388420General Hospital of Shenyang Military RegionAdding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis | 2026-12-31 |
| NCT07505043SUNHO（China）BioPharmaceutical CO., Ltd.First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics | 2027-02-28 |
Add all 8 to your calendar (.ics) → With an account.
Among the 26 studies in Hypertriglyceridemia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy and safety of ethyl icosapentate in Chinese patients with severe hypertriglyceridemia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with any of the following hemorrhagic findings within the last 6 months:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo, orally, twice daily after breakfast and dinner for 12 weeks.
Drug: Placebo
Ethyl Icosapentate 0.9g, orally, twice daily after breakfast and dinner for 12 weeks.
Drug: Ethyl Icosapentate
Ethyl Icosapentate 1.8g, orally, twice daily after breakfast and dinner for 12 weeks.
Drug: Ethyl Icosapentate
Placebo
Ethyl Icosapentate
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
Adverse events after the start of study drug administration
Time frame: 12 weeks
Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Adverse drug reaction after the start of study drug administration
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2020 to primary completion in Jul 2023, 38 months.
Of 28 industry-sponsored phase 3 interventional studies under Hypertriglyceridemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 31. This study's 38 months is above that.
Counting every sponsor, half of 29 studies reached it within 24 months; a quarter within 18 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eicosapentaenoic acid ethyl ester
Mochida Pharmaceutical Company, Ltd.