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

A Randomized, Double Blind Comparator-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 and Atorvastatin 20 mg vs Atorvastatin Monotherapy in Subjects With Moderate Hypercholesterolemia

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: AEGR-733; Drug: Atorvastatin

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pinellas Park, Florida, United States, 33781
      • Linda Murray, DO - Radiant Research
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Sheila Rodstein, MD
  • Ohio
    • Mogadore, Ohio, United States, 44260
      • Dennis McCluskey, MD - Radiant Research
  • Texas
    • Dallas, Texas, United States, 75231
      • Michele Reynolds, MD
    • San Antonio, Texas, United States, 78229
      • William Jennings, MD - Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; 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	Drug: AEGR-733; 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
Active Comparator: 1; Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.	Drug: Atorvastatin; atorvastatin 20 mg tablets, daily dosing, for 8 weeks.; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in LDL-C After 8 Weeks of Therapy	Baseline and 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Aegerion Pharmaceuticals, Inc.
• Investigators: Study Director: Steven Belknap, MD, Medical Monitor at Radiant Research

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Hyperlipidemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: AEGR-733-006