Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Trygg Pharma

Status and phase: Unknown; Phase 3

Conditions: Severe Hypertriglyceridemia

Treatments: Drug: AKR-963

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229566

TRGG-963-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

Active Comparator

Active Comparator group

Description:

Active comparator

Treatment:

Drug: AKR-963

Placebo

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: AKR-963

AKR-963

Experimental group

Description:

Investigational drug

Treatment:

Drug: AKR-963