Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

NCT02072161 | Completed Phase 2

• 1 other identifier: 1002-009
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 40

Brief Summary

The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Conditions

Hypercholesterolemia

Keywords

Statin; LDL; Cholesterol

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)

  12 weeks

Secondary Outcomes (9)

• Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)

  12 weeks

• Percent change in apolipoprotein B (ApoB)

  12 weeks

• Percent change in total cholesterol (TC)

  12 weeks

• Percent change in high-sensitivity C-reactive protein (hsCRP)

  12 weeks

• Percent change in triglycerides (TG)

  12 weeks

Study Arms (3)

ETC-1002 120 mg/day

EXPERIMENTAL

Orally, once daily in morning as capsules

Drug: ETC-1002; Drug: Statin Therapy

ETC-1002 180 mg/day

EXPERIMENTAL

Orally, once daily in morning as capsules

Drug: ETC-1002; Drug: Statin Therapy

Placebo

PLACEBO COMPARATOR

Orally, once daily in morning

Drug: Placebo; Drug: Statin Therapy

Interventions

ETC-1002 DRUG

ETC-1002 capsules, taken once daily oral

ETC-1002 120 mg/day; ETC-1002 180 mg/day

Placebo DRUG

Placebo capsules, taken once daily oral

Placebo

Statin Therapy DRUG

Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.

ETC-1002 120 mg/day; ETC-1002 180 mg/day; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
• Fasting mean TG level ≤400 mg/dL
• Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)

You may not qualify if:

• Clinically significant cardiovascular disease within 12 months of screening
• Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
• Type 1 diabetes or uncontrolled type 2 diabetes
• Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
• History of chronic musculoskeletal symptoms such as fibromyalgia
• Uncontrolled hypothyroidism
• Liver disease or dysfunction
• Renal dysfunction or nephritic syndrome
• Gastrointestinal conditions or procedures or surgeries
• Hematologic or coagulation disorders or low hemoglobin levels
• HIV or AIDS
• History of malignancy
• History of drug or alcohol abuse within 2 years
• Use of experimental or investigational drugs within 30 days of screening
• Use of ETC-1002 in a previous clinical study

Sponsors & Collaborators

• Esperion Therapeutics, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (40)

Unknown Facility

Muscle Shoals, Alabama, 35662, United States

Location

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Chandler, Arizona, 85224, United States

Location

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Chino, California, 91710, United States

Location

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Los Angeles, California, 90057, United States

Location

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Sacramento, California, 95821, United States

Location

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Walnut Creek, California, 94595, United States

Location

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Denver, Colorado, 80220, United States

Location

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Hartford, Connecticut, 06102, United States

Location

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Brandon, Florida, 33511, United States

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Jacksonville, Florida, 32216, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Ponte Vedra, Florida, 32081, United States

Location

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Tampa, Florida, 33606, United States

Location

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West Palm Beach, Florida, 33409, United States

Location

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Marietta, Georgia, 30066, United States

Location

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Boise, Idaho, 83704, United States

Location

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Meridian, Idaho, 83646, United States

Location

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46260, United States

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Wichita, Kansas, 67205, United States

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Louisville, Kentucky, 40213, United States

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Port Gibson, Mississippi, 39150, United States

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Rochester, New York, 14609, United States

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Salisbury, North Carolina, 28144, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Cincinnati, Ohio, 45245, United States

Location

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Columbus, Ohio, 43213, United States

Location

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Franklin, Ohio, 45005, United States

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Lyndhurst, Ohio, 44124, United States

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Marion, Ohio, 43302, United States

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Tulsa, Oklahoma, 74136, United States

Location

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Greer, South Carolina, 29651, United States

Location

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Mt. Pleasant, South Carolina, 29464, United States

Location

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Summerville, South Carolina, 29485, United States

Location

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Kingsport, Tennessee, 37660, United States

Location

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Houston, Texas, 77030, United States

Location

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Bountiful, Utah, 84010, United States

Location

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Orem, Utah, 84058, United States

Location

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Norfolk, Virginia, 23502, United States

Location

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Richmond, Virginia, 23294, United States

Location

Related Publications (4)

• Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.

  PMID: 24385236 BACKGROUND

• Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.

  PMID: 23770179 BACKGROUND

• Filippov S, Pinkosky SL, Lister RJ, Pawloski C, Hanselman JC, Cramer CT, Srivastava RAK, Hurley TR, Bradshaw CD, Spahr MA, Newton RS. ETC-1002 regulates immune response, leukocyte homing, and adipose tissue inflammation via LKB1-dependent activation of macrophage AMPK. J Lipid Res. 2013 Aug;54(8):2095-2108. doi: 10.1194/jlr.M035212. Epub 2013 May 24.

  PMID: 23709692 BACKGROUND

• Pinkosky SL, Filippov S, Srivastava RA, Hanselman JC, Bradshaw CD, Hurley TR, Cramer CT, Spahr MA, Brant AF, Houghton JL, Baker C, Naples M, Adeli K, Newton RS. AMP-activated protein kinase and ATP-citrate lyase are two distinct molecular targets for ETC-1002, a novel small molecule regulator of lipid and carbohydrate metabolism. J Lipid Res. 2013 Jan;54(1):134-51. doi: 10.1194/jlr.M030528. Epub 2012 Nov 1.

  PMID: 23118444 BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Diane E MacDougall

  Esperion Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 24, 2014
• First Posted: February 26, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

US (40)