Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
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
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 24, 2011
November 1, 2010
1.8 years
October 21, 2010
November 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Active Comparator
ACTIVE COMPARATORActive comparator
Placebo
PLACEBO COMPARATORPlacebo control
AKR-963
EXPERIMENTALInvestigational drug
Interventions
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Illinois Recruiting
Chicago, Illinois, 60101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin C Maki, PhD
Addison, Illinois Recruiting
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 27, 2010
Study Start
October 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 24, 2011
Record last verified: 2010-11