Phase 2
Completed N=120
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Dyslipidemias · High Cholesterol · Hypercholesterolemia
Source: ClinicalTrials.gov NCT04753606 ↗
Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Jun 2024
Primary outcomePrimary: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] — -5.48; -37.97; -43.35 percent change from baseline — p=<.0001
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] |
-5.48; -37.97; -43.35 | <.0001 sig |
| PRIMARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] |
0; -42.90; -45.65 | <.0001 sig |
| PRIMARY LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] |
-5.00; -37.97; -44.18 | <.0001 sig |
| PRIMARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
-7.11; -35.98; -46.06 | <.0001 sig |
| PRIMARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
-6.50; -41.45; -50.75 | <.0001 sig |
| PRIMARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
-6.70; -35.65; -46.77 | <.0001 sig |
| SECONDARY Mean Percent Change in Apolipoprotein B (ApoB) |
-4.67; -22.62; -27.19 | <.0001 sig |
| SECONDARY Median Percent Change in Apolipoprotein B (ApoB) |
-2.60; -24.40; -29.75 | <.0001 sig |
| SECONDARY LS Mean Percent Change in Apolipoprotein B (ApoB) |
-4.13; -22.40; -28.12 | <.0001 sig |
| SECONDARY Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-4.22; -34.28; -39.25 | <.0001 sig |
| SECONDARY Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-3.50; -38.90; -44.40 | <.0001 sig |
| SECONDARY LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-3.83; -34.37; -39.86 | <.0001 sig |
| SECONDARY Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) |
-6.62; 123.92; 156.41 | <.0001 sig |
| SECONDARY Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) |
-4.90; 135.40; 164.95 | <.0001 sig |
| SECONDARY LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) |
-6.98; 122.29; 157.35 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- LDL-C > 70 mg/dL and TG 40 kg/m
- Significant cardiovascular disease
- HbA1c > 10%
- Uncontrolled hypertension
- Active muscle disease
- GFR < 60 ml/min
- Hepatic dysfunction
- Anemia
- History of malignancy
- Alcohol abuse
- Treatment with investigational product
- Treatment with PCSK9
- Clinically significant condition
- Known CETP inhibitor allergy
Data sourced from ClinicalTrials.gov (NCT04753606). 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.