Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Sponsor

Trygg Pharma, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01229566

Collaborator

(none)

240

Enrollment

Location

Arms

Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Hypertriglyceridemia	Drug: AKR-963	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Comparator Active comparator	Drug: AKR-963 3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Placebo Comparator: Placebo Placebo control	Drug: AKR-963 3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Experimental: AKR-963 Investigational drug	Drug: AKR-963 3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Arm

Intervention/Treatment

Active Comparator: Active Comparator

Active comparator

Drug: AKR-963

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

Placebo Comparator: Placebo

Placebo control

Drug: AKR-963

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

Experimental: AKR-963

Investigational drug

Drug: AKR-963

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

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Illinois Recruiting	Chicago	Illinois	United States	60101

Sponsors and Collaborators

Trygg Pharma, Inc.

Investigators

Principal Investigator: Kevin C Maki, PhD, Addison, Illinois Recruiting

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Trygg Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT01229566

Other Study ID Numbers:

TRGG-963-002

First Posted:

Oct 27, 2010

Last Update Posted:

Nov 24, 2011

Last Verified:

Nov 1, 2010

Additional relevant MeSH terms:

Hypertriglyceridemia

Study Results

No Results Posted as of Nov 24, 2011