Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension

NCT02178098 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1002-014
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 43

Brief Summary

This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.

Conditions

Hypercholesterolemia; Hypertension

Keywords

LDL; Cholesterol

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6

  Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. For the Week 6 endpoint, missing values at Week 6 were imputed using the last observation carried forward (LOCF) procedure, with only post-Baseline values carried forward. Modified Intent-to-Treat (mITT) Population is defined as all randomized participants who received at least 1 dose of study drug, had a Baseline assessment, and had at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of study drug

  Baseline; 6 weeks

Secondary Outcomes (17)

• Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6

  Baseline; 6 weeks

• Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6

  Baseline; 6 weeks

• Change From Baseline in Mean Daytime SBP to Week 6

  Baseline; 6 weeks

• Change From Baseline in Mean Daytime DBP to Week 6

  Baseline; 6 weeks

• Change From Baseline in Mean Nighttime SBP to Week 6

  Baseline; 6 weeks

Study Arms (2)

ETC-1002

EXPERIMENTAL

ETC-1002 180 mg/day

Drug: ETC-1002

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

ETC-1002 DRUG

ETC-1002 capsules taken once daily

ETC-1002

Placebo DRUG

Placebo capsules taken once daily

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:

• Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
• or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
• Fasting LDL-C between 100 and 220 mg/dL
• Fasting triglycerides less than 400 mg/dL
• Body mass index (BMI) between 18 and 45 kg/m2

You may not qualify if:

• Known or suspected secondary hypertension or history of malignant hypertension
• Taking more than two anti-hypertension medications at the first visit
• History or current clinically significant cardiovascular disease
• History or current type 1 diabetes or type 2 diabetes

Sponsors & Collaborators

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

Study Sites (43)

Unknown Facility

Birmingham, Alabama, 35209, United States

Location

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Muscle Shoals, Alabama, 35662, United States

Location

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Chandler, Arizona, 85224, United States

Location

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Glendale, Arizona, 85306, United States

Location

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Los Angeles, California, 90057, United States

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DeLand, Florida, 32720, United States

Location

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Fort Lauderdale, Florida, 33306, United States

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Hialeah, Florida, 33012, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Pembroke Pines, Florida, 33026, United States

Location

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Pembroke Pines, Florida, 33029, United States

Location

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Port Orange, Florida, 32127, United States

Location

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Meridian, Idaho, 83646, United States

Location

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Chicago, Illinois, 60607, United States

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Gurnee, Illinois, 60031, United States

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Indianapolis, Indiana, 46260, United States

Location

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Paducah, Kentucky, 42003, United States

Location

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Auburn, Maine, 04210, United States

Location

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Olive Branch, Mississippi, 38654, United States

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Butte, Montana, 59701, United States

Location

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Las Vegas, Nevada, 89123, United States

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Berlin, New Jersey, 08009, United States

Location

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Endwell, New York, 13760, United States

Location

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Wilmington, North Carolina, 28401, 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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Cincinnati, Ohio, 45246, United States

Location

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Lyndhurst, Ohio, 44124, United States

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Willoughby Hills, Ohio, 44094, United States

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Tulsa, Oklahoma, 74136, United States

Location

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Eugene, Oregon, 97404, United States

Location

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Downingtown, Pennsylvania, 19335, United States

Location

Site 1

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 2

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Simpsonville, South Carolina, 29681, United States

Location

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Corpus Christi, Texas, 78404, United States

Location

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Dallas, Texas, 75230, United States

Location

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Dallas, Texas, 75234, United States

Location

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Houston, Texas, 77036, United States

Location

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Salt Lake City, Utah, 84107, United States

Location

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Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

Kenosha, Wisconsin, 53142, United States

Location

Unknown Facility

Madison, Wisconsin, 53719, United States

Location

Related Publications (4)

• 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

• 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

• 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

• 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

MeSH Terms

Conditions

Hypercholesterolemia; Hypertension

Interventions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Esperion Therapeutics, Inc.

medinfo@esperion.com

1-833-377-7633

Study Officials

• Medpace Medical Monitor

  Medpace, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 16, 2014
• First Posted: June 30, 2014
• Study Start: June 16, 2014
• Primary Completion: May 22, 2015
• Study Completion: May 22, 2015
• Last Updated: April 4, 2023
• Results First Posted: April 4, 2023

Record last verified: 2023-03

Locations

US (43)