omega-3 ethylester concentrate / Generic mfg. - LARVOL DELTA

Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: Carsten Skarke, MD | Trial completion date: Nov 2028 ➔ Nov 2029 | Trial primary completion date: Nov 2026 ➔ Nov 2027

Biomarker • Trial completion date • Trial primary completion date

Severe Hypertriglyceridemia in Pregnancy: A Case Highlighting Therapeutic Challenges (AHA 2025) - "Prior to conception, she had been treated with a biguanide for diabetes and a combination of fish oil, fenofibrate, and a statin for HTG, which were discontinued for fetal safety. Given the markedly elevated TG level, a multidisciplinary decision was made to urgently reinitiate lipid-lowering therapy with omega-3 acid ethyl esters 4g daily (Lovaza) and subcutaneous insulin glargine...Traditional lipid-lowering agents, including statins, PCSK9 inhibitors, ezetimibe, bempedoic acid, and lomitapide, are generally avoided during pregnancy due to limited fetal safety data...Thus, cardio-obstetric management of high-risk women with metabolic disorders should center around preconception risk assessment, multidisciplinary care, intensive lifestyle modification, selective use of non-statin agents or apheresis, and vigilant monitoring throughout pregnancy. There remains a significant gap in evidence regarding the safety and efficacy of lipid-lowering therapies during pregnancy,..."

Clinical • Diabetes • Dyslipidemia • Gynecology • Hypertriglyceridemia • Obstetrics • Pancreatitis • Severe Hypertriglyceridemia • Type 2 Diabetes Mellitus

Management of Acute Pancreatitis Due to Hypertriglyceridemia in Pregnancy (ACG 2025) - "Plasmapheresis was considered due to the severity and risk to the pregnancy, but ultimately, the patient was treated supportively and improved clinically with bowel rest, insulin drip, fenofibrate, Niaspan, and Lovaza. In conclusion, patients with suspected familial hypertriglyceridemia should be counseled on triglyceride management before pregnancy to prevent this complication. Furthermore, in the event of developing hypertriglyceridemia-induced acute pancreatitis in pregnancy, plasmapheresis can be considered for treatment."

Diabetes • Dyslipidemia • Gastroenterology • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Pancreatitis • Type 2 Diabetes Mellitus

Effect of Omega-3 Free Fatty Acid Supplementation on Crohn's Disease: A Meta-Analysis of Randomized Controlled Trials (ACG 2025) - "used 12-month fish oil capsules; Lorenz-Meyer et al., an 8-week EPA-enriched enteral formula; Feagan et al., Omacor for 58 weeks... Five randomized controlled trials (n = 414) were included. The pooled mean difference in CDAI scores between omega-3 and control groups was 38.73 (95% CI: -10.85 to 88.32, p = 0.126), showing no statistically significant effect. Heterogeneity was high (I² = 97.5%, τ² = 2674.12, Q = 79.18, p < 0.0001)."

Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Trends in utilization and cost of triglyceride-lowering therapies among Medicare beneficiaries: An analysis from the Medicare part D database. (PubMed, Am J Prev Cardiol) - "We used the Medicare Part D Prescriber dataset from 2013 to 2021 to identify all generic and brand name formulations of triglyceride-lowering therapies (fibrates, omega-3 acid ethyl esters, and niacin)...These trends likely reflect changes in the evidence base and guideline recommendations for hypertriglyceridemia treatment. While most beneficiaries received generic medications when available, substantial spending on brand name medications persists, indicating potential missed opportunities for cost savings."

Journal • Medicare • Reimbursement • US reimbursement • Atherosclerosis • Cardiovascular • Dyslipidemia • Hypertriglyceridemia

The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery (clinicaltrials.gov) - P2 | N=90 | Enrolling by invitation | Sponsor: University of Missouri-Columbia | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Cardiovascular • CNS Disorders • Geriatric Disorders

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jun 2025 ➔ Mar 2025

Biomarker • Trial primary completion date • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

OMECARDIO trial: a randomized, double-blind, placebo-controlled study on the impact of omega-3 on inflammageing biomarkers and vascular stiffness in hypertensive and dyslipidemic patients (ESC-WCC 2025) - "Participants were randomly assigned (1:1) to receive either 2 grams of omega-3 ethyl esters (46% EPA, 38% DHA, and 4 mg of soy alpha-tocopherol) or a matching placebo daily for 12 weeks... The reduction in levels of inflammatory biomarkers and vascular stiffness associated with the intake of 2 grams of omega-3 daily in patients with higher cardiovascular risk due to hypertension and dyslipidemia suggests that this could be a highly accessible and scalable strategy to address the challenge of inflammaging in this population. While this is a surrogate outcome, it is linked to an increased risk of accelerated aging and events, particularly in an era of rising longevity and the need to reduce exposure to chronic systemic inflammation."

Biomarker • Clinical • Cardiovascular • Dyslipidemia • Hypertension • CRP

A Prospective, Multicenter, Randomized, Controlled, Open-Label, Blinded Endpoint Trial Evaluating the Efficacy, Safety, and Cost-Effectiveness of Omega-3 Ethyl Esters in Mixed Dyslipidemia (ChiCTR) - P=N/A | N=492 | Not yet recruiting | Sponsor: Beiing Anzhen Hospital. Capital Medical University; Beijing Association of Holistic Integrative Medicine

HEOR • New trial • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

Comparative Risk of Atrial Fibrillation Onset in Statin-Treated Patients Initiating Icosapent Ethyl and Omega-3 Acid Ethyl Esters: A Retrospective Cohort Study. (PubMed, J Am Heart Assoc) - "These findings suggest that, in adult patients who are AF naïve, IPE may be associated with a higher risk of AF compared with DHA/EPA when used as add-on therapy with statins."

Journal • Retrospective data • Atrial Fibrillation • Cardiovascular • Dyslipidemia • Metabolic Disorders

Enhancing tofacitinib's therapeutic efficacy in murine arthritis with a synbiotic formulation comprising Bacillus megaterium DSM 32963 and an Omega-3 fatty acid lysine salt. (PubMed, Front Immunol) - "Our findings reveal that a combination of low-dose tofacitinib and the synbiotic (ldTofa+Syn) significantly improved all measured arthritis severity parameters, outperforming either single treatment as well as supplementation with a conventional omega-3 ethyl ester that showed no effects on disease severity. Additionally, there was a marked trend towards lower levels of the key inflammatory cytokines TNFα, IL-1β, and IL-6 in the ldTofa+Syn group. In conclusion, the specific synbiotic formulation shows promise as a complementary nutritional therapy for RA, improving disease outcomes and modulating immune responses."

Journal • Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • CXCL1 • IL1B • IL6 • TNFA

An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin (clinicaltrials.gov) - P4 | N=17 | Completed | Sponsor: Provident Clinical Research | N=13 ➔ 17 | Unknown status ➔ Completed

Enrollment change • Trial completion • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=75 ➔ 19 | Trial completion date: Aug 2025 ➔ May 2026

Biomarker • Enrollment change • Enrollment closed • Trial completion date • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

The effectiveness of the current lipid-lowering therapy for refractory dyslipidaemia in patients with coronary artery disease: the price of "the lower, the better" - results of a survey by Japanese cardiologists. (PubMed, Expert Opin Pharmacother) - "The use of maximally tolerated statins in routine clinical practice did not differ between the low and high groups, but ezetimibe (5.73 vs. 6.26; p = 0.0357), EPA (2.51 vs. 2.98; p = 0.0339), and omega-3-acid ethyl esters (2.03 vs. 2.55; p = 0.0124) were more prescribed in the latter than in the former group. Cardiologists prescribe ezetimibe to patients with refractory DL-CAD even with maximally tolerated statin doses. They have shifted to a strategy of intervening with high triglycerides and polyunsaturated fatty acids to reduce residual risk if maximally tolerated statin and ezetimibe fail to achieve the target low density lipoprotein cholesterol."

Journal • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2027 ➔ Oct 2027

Enrollment open • Trial primary completion date • Breast Cancer • Obesity • Oncology • Solid Tumor

The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: University of Missouri-Columbia | Trial completion date: Nov 2025 ➔ Feb 2027 | Initiation date: Nov 2024 ➔ Aug 2025 | Trial primary completion date: Nov 2025 ➔ Aug 2026

Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • CNS Disorders • Geriatric Disorders

TRENDS IN UTILIZATION AND COST OF TRIGLYCERIDE-LOWERING THERAPIES AMONG MEDICARE BENEFICIARIES: AN ANALYSIS FROM THE MEDICARE PART D DATABASE - Krista Zachariah (ACC 2025) - "Among Medicare Part D beneficiaries, use and spending on fibrates and niacin declined, while use and spending on omega-3 acid ethyl esters increased. These trends likely reflect changes in the evidence base and guideline recommendations for hypertriglyceridemia treatment. While most beneficiaries received generic medications when available, substantial spending on brand-name medications persists, indicating potential missed opportunities for cost savings."

Medicare • Reimbursement • US reimbursement • Cardiovascular • Dyslipidemia • Hypertriglyceridemia

EMiRA: The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation (clinicaltrials.gov) - P3 | N=174 | Completed | Sponsor: Joe Chan | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Mar 2025

Trial completion • Trial completion date • Fibrosis • Immunology • Nephrology • Transplantation

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: May 2025 ➔ Aug 2025 | Trial primary completion date: May 2025 ➔ Aug 2025

Biomarker • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2027 ➔ Jan 2028

Trial completion date • Breast Cancer • Obesity • Oncology • Solid Tumor • AGR2 • FOXA1 • LEP

OMECARDIO: Effect of Omega 3 in Hypertensive Patients (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: Santa Maria de la Salud, Argentina

New trial • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Unmasking a Rare Genetic Mutation: The Importance of Genetic Testing in Refractory Hypertriglyceridemia. (PubMed, AACE Clin Case Rep) - "A 45-year-old Hispanic female presented with serum triglyceride levels of 749 mg/dL, refractory to rosuvastatin 10 mg daily and omega-3 ethyl esters 2 g daily...Despite treatment escalation with gemfibrozil, fenofibrate, and icosapent ethyl, her triglyceride levels remained elevated, peaking at 4300 mg/dL...We underscore the importance of genetic testing in refractory hypertriglyceridemia despite a lack of clinical signs. A definitive diagnosis can alleviate patient burden, improve therapeutic adherence, and enhance the patient-physician relationship."

Journal • Dyslipidemia • Familial Chylomicronemia Syndrome • Hypertriglyceridemia • Metabolic Disorders • Pancreatitis • APOA5 • LPL

QUILT-3.060t: QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: ImmunityBio, Inc. | N=80 ➔ 6 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

Enrollment change • Trial termination • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Biomarker • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Icosapent Ethyl-Associated New Atrial Fibrillation Incidence compared to Omega-3 Fatty Acids: An Observational Cohort Study (AHA 2024) - "Introduction: Icosapent ethyl (IE), an ethyl ester derivative of eicosapentanoic acid (EPA), and omega-3 acid ethyl esters, an ethyl ester derivative of both EPA and docosahexaenoic acid (DHA), are approved as adjunct to statin therapy for reducing MACE in patients with elevated triglyceride levels. IE is associated with a higher risk of AF compared to DHA/EPA combined products, indicating the need for careful risk-benefit discussion between clinicians and patients considering IE therapy."

Observational data • Atrial Fibrillation • Cardiovascular