NCT01242527 (EVOLVE) is a Phase 2/Phase 3 clinical trial of omefas in Severe Hypertriglyceridemia, sponsored by AstraZeneca.

Who is sponsoring NCT01242527?

NCT01242527 is sponsored by AstraZeneca.

What drugs are being tested in NCT01242527?

Interventions in NCT01242527: placebo, omefas, omefas, omefas.

What condition does NCT01242527 study?

NCT01242527 studies Severe Hypertriglyceridemia.

Is NCT01242527 still recruiting?

NCT01242527 is currently completed. Last updated 24 June 2016.

Are results published for NCT01242527?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-06-24 · How we verify

NCT01242527: EVOLVE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia

Completed Phase 2/Phase 3 Results posted Last updated 24 June 2016

What this trial tests

Phase 2/Phase 3 trial testing placebo in Severe Hypertriglyceridemia in 399 participants. Completed in 1 April 2012.

Timeline

1 January 2011

Primary endpoint
1 March 2012

1 April 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	399
Start date	1 January 2011
Primary completion	1 March 2012
Estimated completion	1 April 2012
Sites	68 locations across United States, Denmark, Hungary, India, Netherlands, Russia, Ukraine

Drugs / interventions tested

placebo
omefas — full drug profile →
omefas — full drug profile →
omefas — full drug profile →

Conditions studied

Severe Hypertriglyceridemia — all drugs for Severe Hypertriglyceridemia →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Severe Hypertriglyceridemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Fasting Serum Triglycerides
Time frame: 12 weeks
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups

Sponsor's own description

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial.
Kastelein JJ, Maki KC, Susekov A, Ezhov M, et al · · 2014 · cited 171× · PMID 24528690 · DOI 10.1016/j.jacl.2013.10.003
The effect of omega-3 fatty acids and its combination with statins on lipid profile in patients with hypertriglyceridemia: A systematic review and meta-analysis of randomized controlled trials.
Yang Y, Deng W, Wang Y, Li T, et al · · 2022 · cited 7× · PMID 36313109 · DOI 10.3389/fnut.2022.1039056
Established and emerging approaches for the management of dyslipidaemia.
Norata GD. · · 2012 · PMID 24278703 · DOI 10.6064/2012/482423

Verify or expand the search:

Other AstraZeneca trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01242527 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 24 June 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01242527.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing