Phase 2
Completed N=143
Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
Source: ClinicalTrials.gov NCT02178098 ↗Enrolled (actual)
143
Serious AEs
4.2%
Results posted
Apr 2023
Primary outcomePrimary: Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6 — 3.16; -21.08 Percent Change — p=<0.0001
Summary
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6 |
3.16; -21.08 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6 |
-0.64; -2.28 | 0.2808 |
| SECONDARY Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6 |
-0.05; -1.10 | 0.3461 |
| SECONDARY Change From Baseline in Mean Daytime SBP to Week 6 |
-0.35; -2.66 | 0.1852 |
| SECONDARY Change From Baseline in Mean Daytime DBP to Week 6 |
-0.01; -1.47 | 0.2481 |
| SECONDARY Change From Baseline in Mean Nighttime SBP to Week 6 |
-1.18; -1.57 | 0.8181 |
| SECONDARY Change From Baseline in Mean Nighttime DBP to Week 6 |
-0.52; -0.33 | 0.8817 |
| SECONDARY Change From Baseline in Sitting Cuff SBP to Week 6 |
-4.98; -3.45 | 0.4040 |
| SECONDARY Change From Baseline in Sitting Cuff DBP to Week 6 |
-3.32; -2.53 | 0.5061 |
| SECONDARY Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6 |
19.61; -25.00 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol to Week 6 |
2.90; -13.77 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6 |
4.77; -14.13 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6 |
3.20; -15.49 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) to Week 6 |
-3.75; -0.07 | 0.3689 |
| SECONDARY Percent Change From Baseline in HDL-C to Week 6 |
2.42; -5.76 | 0.0006 sig |
| SECONDARY Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6 |
1.08; 9.56 | 0.3093 |
| SECONDARY Change From Baseline in Body Weight to Week 6 |
-0.335; -0.009 | — |
| SECONDARY Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228 |
6666.20; 6817.45; 6836.36; 1219.60; 1220.79; 1221.32 | — |
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
Data sourced from ClinicalTrials.gov (NCT02178098). 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. Informational only — not medical advice.