Phase 2
N=56
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01751984 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Apr 2022
Primary outcome: Primary: Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) — -32.0; -3.3 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
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) |
-32.0; -3.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C |
-19.5; -1.4; -31.0; -1.0; -32.6; -3.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C) |
-8.2; -2.4 | 0.1892 |
| SECONDARY Percent Change From Baseline to Week 8 in Non-HDL-C |
-25.4; -4.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline to Week 8 in Total Cholesterol |
-22.2; -3.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline to Week 8 in Triglycerides |
11.2; -7.4 | =0.0962 |
| SECONDARY Percent Change From Baseline to Week 8 in Apolipoprotein B |
-19.7; -4.4 | =0.0019 sig |
| SECONDARY Percent Change From Baseline to Week 8 in Apolipoprotein AI |
-4.2; 0.1 | =0.2555 |
| SECONDARY Percent Change From Baseline to Week 8 in Lipoprotein (a) |
10.4; -1.2 | 0.2563 |
| SECONDARY Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP) |
-22.6; 1.1 | 0.2565 |
| SECONDARY Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA) |
14.3; 10.4 | 0.7760 |
| SECONDARY Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment |
21; 0; 13; 17 | <0.0001 sig |
| SECONDARY Number or Participants With Treatment-emergent Adverse Events (TEAEs) |
26; 15 | — |
| SECONDARY Number of Participants With Muscle-Related TEAEs |
12; 7 | — |
Summary
This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.
Eligibility Criteria
Key Inclusion Criteria
- A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
- For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides <350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
- For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG <400 mg/dL
Key Exclusion Criteria
- Acute significant cardiovascular disease
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT01751984). 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.