Back to resultsEfficacy Study to Treat Subjects With Severe Hypertriglyceridemia
Primary Purpose
Severe Hypertriglyceridemia
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AKR-963
Sponsored by
About this trial
This is an interventional treatment trial for Severe Hypertriglyceridemia
Eligibility 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
Sites / Locations
- Illinois Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
Active Comparator
Placebo
AKR-963
Arm Description
Active comparator
Placebo control
Investigational drug
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229566
Brief Title
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trygg Pharma, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Active comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo control
Arm Title
AKR-963
Arm Type
Experimental
Arm Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
AKR-963
Intervention Description
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Primary Outcome Measure Information:
Title
Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]
Description
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).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C Maki, PhD
Organizational Affiliation
Addison, Illinois Recruiting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois Recruiting
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
12. IPD Sharing Statement
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Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
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