This trial is active, not recruiting.

Condition severe hypertriglyceridemia
Treatment akr-963
Phase phase 3
Sponsor Trygg Pharma, Inc.
Start date October 2010
End date July 2012
Trial size 240 participants
Trial identifier NCT01229566, TRGG-963-002


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Active comparator
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
(Placebo Comparator)
Placebo control
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Investigational drug
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

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

Additional Information

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
Principal investigator Kevin C Maki, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Trygg Pharma, Inc..