Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Severe Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01229566
• Other study ID #: TRGG-963-002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 21, 2010
• Last updated: November 23, 2011
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2010
• Source: Trygg Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Severe Hypertriglyceridemia

Intervention

Drug:
• AKR-963
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Locations

Country	Name	City	State
United States	Illinois Recruiting	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Trygg Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 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).	12 weeks	No