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UNKNOWNPHASE3

Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects With Severe Hypertriglyceridemia

NCT01229566•Trygg Pharma, Inc.

View on ClinicalTrials.gov

Summary

The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.

Detailed Description

Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, ages 18-79
•Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL
•Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria

•Women who are pregnant or lactating, or planning to become pregnant
•Use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects
•History of pancreatitis
•History of bariatric surgery or currently on weight loss drugs or in weight loss programs
•Treatment with any agent that may affect lipid levels or hepatic function
•Consumption of more than 3 alcoholic beverages per day
•History of cancer within last 2 years
•Participation in another clinical trial involving an investigational agent in the last 30 days
•Other parameters will be assessed at the study center to ensure eligibility for this study

Locations (1)

Illinois Recruiting

Chicago, Illinois, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

November 24, 2011

Enrollment

240

ESTIMATED participants

Conditions

Severe Hypertriglyceridemia

Interventions

AKR-963

DRUG

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

NCT05552326

Severe Hypertriglyceridemia

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COMPLETEDPHASE2

Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

NCT03452228

Severe Hypertriglyceridemia (sHTG)

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WITHDRAWNPHASE3

The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.