Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

November 23, 2011 updated by: Trygg Pharma, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60101
        • Illinois Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trygg Pharma, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 26, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 23, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRGG-963-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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