A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)

Summary

The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be screened to obtain 245 randomized subjects following a 2.5:1 treatment allocation ratio (CaPre: placebo).

Timeline

Start

2018-01-23

Primary completion

2019-07-21

Completion

2019-11-20

Outcome

Met primary endpoint

paper mean treatment difference, -10.9% [95% CI, -20.4% to -1.5%]; P = .02 PMID 34989797 ↗

Publications

• Mozaffarian D, Maki KC, Bays HE, Aguilera F, Gould G, Hegele RA, Moriarty PM, Robinson JG, Shi P, Tur JF, Lapointe JF, Aziz S, Lemieux P; TRILOGY (Study of CaPre in Lowering Very High Triglycerides) investigators. Effectiveness of a Novel omega-3 Krill Oil Agent in Patients With Severe Hypertriglyceridemia: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2141898. doi: 10.1001/jamanetworkopen.2021.41898.

Drugs

Indications