Clinical trial NCT02178098: Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Hypertension
Keywords: LDL
Cholesterol
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2014-06-30
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6
timeFrame: Baseline; 6 weeks
Secondary outcomes:
measure: Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in Mean Daytime SBP to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in Mean Daytime DBP to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in Mean Nighttime SBP to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in Mean Nighttime DBP to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in Sitting Cuff SBP to Week 6
timeFrame: Baseline: 6 weeks
measure: Change From Baseline in Sitting Cuff DBP to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in Total Cholesterol to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in Triglycerides (TG) to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in HDL-C to Week 6
timeFrame: Baseline; 6 weeks
measure: Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6
timeFrame: Baseline; 6 weeks
measure: Change From Baseline in Body Weight to Week 6
timeFrame: Baseline; 6 weeks
measure: Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228
timeFrame: Week 2, Week 4 and Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: DeLand
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Paducah
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: Olive Branch
country: United States
state: Mississippi
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Endwell
country: United States
state: New York
city: Wilmington
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Downingtown
country: United States
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Site 1
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site 2
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Kenosha
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Medpace, Inc.
name: Medpace Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.