NCT04662528

Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL

A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Matinas Biopharma, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of MAT9001 compared to placebo in lowering fasting triglyceride levels in subjects with very high fasting triglyceride levels ≥ 500 and \< 2000 mg/dL.

Detailed description

This will be a 12-week, randomized, double blind, placebo-controlled safety and efficacy study in men and women ≥18 years of age with fasting triglycerides ≥500 mg/dL and \<2000 mg/dL while following a Therapeutic Lifestyle changes (TLC) diet.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Placebo	4 x 1g capsules/day
DRUG	MAT9001 (omega-3 pentaenoic acid)	4 x 1g capsules/day

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-08-01
• Completion: 2022-10-01
• First posted: 2020-12-10
• Last updated: 2021-09-16

Regulatory

• FDA-regulated drug study