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Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Trygg Pharma, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Trygg Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01229566
First received: October 21, 2010
Last updated: November 23, 2011
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Severe Hypertriglyceridemia
 Drug: AKR-963
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Further study details as provided by Trygg Pharma, Inc.:

Primary Outcome Measures:
  • Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 240
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229566

Locations
United States, Illinois
Illinois Recruiting
Chicago, Illinois, United States, 60101
Sponsors and Collaborators
Trygg Pharma, Inc.
Investigators
Principal Investigator: Kevin C Maki, PhD Addison, Illinois Recruiting
  More Information

No publications provided

Responsible Party: Trygg Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01229566     History of Changes
Other Study ID Numbers: TRGG-963-002
Study First Received: October 21, 2010
Last Updated: November 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013