Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Phase 3

• Conditions: Severe Hypertriglyceridemia
• Interventions: Drug: AKR-963

• Registration Number: NCT01229566
• Lead Sponsor: Trygg Pharma, Inc.

Brief 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).

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Status Verified: 2010-11
• Last Update Submitted: 2011-11-23
• Last Update Posted: 2011-11-24
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	AKR-963	Placebo control
AKR-963	AKR-963	Investigational drug
Active Comparator	AKR-963	Active comparator

Primary Outcome Measures

Name	Time	Method
Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]	12 weeks	The percent change in TG levels from baseline (average of Weeks -2, -1, and 0) to the end of Period A, first 12-week double-blind treatment, (average of Weeks 11 and 12).

Trial Locations

Locations (1)

Illinois Recruiting; 🇺🇸 Chicago, Illinois, United States