Phase 2
N=177
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01262638 ↗Enrolled (actual)
177
Serious AEs
0.6%
Results posted
Mar 2021
Primary outcome: Primary: Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) — -17.9; -25.0; -26.6; -2.1 Percent Change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ETC-1002 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Esperion Therapeutics, Inc.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) |
-17.9; -25.0; -26.6; -2.1 | <0.0001 sig |
| PRIMARY Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum |
-17.8; -21.9; -29.2; 0.3; -17.8; -28.1 | — |
| SECONDARY Percent Change From Baseline to Week 12 in TG |
-15.1; -10.6; 1.1; -1.2 | — |
| SECONDARY Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C) |
7.2; 0.9; 4.4; 2.4 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Non-HDL-C |
-17.4; -22.7; -23.0; -2.3 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Total Cholesterol (TC) |
-11.5; -17.8; -17.1; -1.4 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) |
-14.6; -18.4; -22.1; -0.9 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI) |
2.9; -2.7; 0.0; -3.1 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Lipoprotein (a) |
0.3; 7.6; 16.2; -2.7 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA) |
2.5; -14.4; 5.3; 3.6 | — |
| SECONDARY Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP) |
18.4; 57.0; 48.0; 86.6 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Total LDL Particles |
-14.8; -16.3; -20.7; 1.9 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Total HDL Particles |
5.7; 3.6; 7.3; 0.4 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
34; 32; 31; 33 | — |
| SECONDARY Number of Participants With Clinically Significant Physical Examination Findings |
2; 2; 0; 2 | — |
| SECONDARY Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12 |
4; 3; 3; 4; 5; 6 | — |
Summary
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
Eligibility Criteria
Major Inclusion Criteria:
- Provision of written informed consent prior to any study-specific procedure
- Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
- Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements
- BMI between 18 and 35 mg/kg2
Major Exclusion Criteria:
- Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
- Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
Data sourced from ClinicalTrials.gov (NCT01262638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.