Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: AEGR-733; Drug: Atorvastatin

• Registration Number: NCT00690443
• Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Brief Summary

Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.

Detailed Description

Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2013-01-18
• Results First Submitted QC: 2013-01-18
• Results First Posted: 2013-02-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• M/F 18-70
• 0-1 risk factor, mean LDL-C -/> 160 and -/< 250 mg/dL (Visit 2 & 3)
• 2+ risk factors, mean LDL-C -/> 130 & -/< 250 mg/dL (Visit 2 & 3)
• Fasting mean TGs -/< 400 mg/dL
• Understanding and compliance of protocol
• sign consent

Exclusion Criteria

• Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
• Uncontrolled hypertension >180/95 at screening
• Hx of chronic renal insufficiency (serum creatinine > 2.5 mg/dL)
• Hx of liver disease or transaminases > 1.5 X ULN
• Positive for Hepatitis B or C
• Major surgery within past 3 mos
• Cardiac insufficiency defined as functional Class II-Class IV
• Hx of malignancy within previous 5 years
• Participation in another investigational drug study within past 6 wks
• Serious or unstable medical or psychological condition
• Regular alcohol use > 1 drink per day
• Regular consumers of grapefruit juice or medications known to be metabolized by CYP 3A4
• Use of other lipid-lowering meds (washout permitted)
• Acute CVD
• Diabetes Mellitus
• Fasting glucose >110 mg/dL
• BMI -/> 40 kg/m2
• Significant gastrointestinal symptoms such as IBS
• Use of fish oils, niacin, herbal wt. loss products (washout permitted)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AEGR-733	2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8
1	Atorvastatin	Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.

Primary Outcome Measures

Name	Time	Method
Percent Change in LDL-C After 8 Weeks of Therapy	Baseline and 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.	Baseline and 4 weeks

Trial Locations

Locations (5)

Michele Reynolds, MD; 🇺🇸 Dallas, Texas, United States

Linda Murray, DO - Radiant Research; 🇺🇸 Pinellas Park, Florida, United States

Dennis McCluskey, MD - Radiant Research; 🇺🇸 Mogadore, Ohio, United States

Sheila Rodstein, MD; 🇺🇸 Edina, Minnesota, United States

William Jennings, MD - Radiant Research; 🇺🇸 San Antonio, Texas, United States