Phase 2
Completed N=102
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
Dyslipidemia · Hypercholesterolemia · High Cholesterol
Source: ClinicalTrials.gov NCT05421078 ↗
Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Sep 2024
Primary outcomePrimary: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] — -0.78; -25.90; -33.78; -36.80 percent change from baseline — p=<.0001
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] |
-0.78; -25.90; -33.78; -36.80 | <.0001 sig |
| PRIMARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] |
-0.89; -24.81; -31.94; -45.80 | <.0001 sig |
| PRIMARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] |
-0.48; -26.32; -33.82; -36.60 | <.0001 sig |
| PRIMARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
0.43; -26.10; -30.50; -36.29 | <.0001 sig |
| PRIMARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
0.67; -25.97; -30.40; -43.72 | <.0001 sig |
| PRIMARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
0.69; -26.51; -30.54; -36.12 | <.0001 sig |
| SECONDARY Mean Percent Change in Apolipoprotein B (ApoB) |
-1.23; -19.80; -24.48; -26.66 | <.0001 sig |
| SECONDARY Median Percent Change in Apolipoprotein B (ApoB) |
-0.36; -22.50; -21.43; -29.67 | <.0001 sig |
| SECONDARY LS Mean Percent Change in Apolipoprotein B (ApoB) |
-1.42; -20.43; -23.87; -26.29 | <.0001 sig |
| SECONDARY Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-1.80; -25.42; -30.38; -30.25 | <.0001 sig |
| SECONDARY Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-0.37; -23.74; -29.82; -36.96 | <.0001 sig |
| SECONDARY LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-1.72; -25.66; -30.11; -30.28 | <.0001 sig |
| SECONDARY Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) |
5.57; 134.75; 153.16; 158.75 | <.0001 sig |
| SECONDARY Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) |
5.22; 114.29; 144.44; 158.90 | <.0001 sig |
| SECONDARY LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) |
3.90; 137.00; 151.30; 159.87 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- LDL-C > 70 mg/dL and TG or =35 kg/m2
- Significant cardiovascular disease
- HbA1c > 10%
- Uncontrolled hypertension
- Active muscle disease
- GFR < 60 ml/min
- Hepatic dysfunction
- Anemia
- Existing CETP deficiency
- History of Homozygous Familial Hypercholerstrolemia
- History of malignancy
- Alcohol abuse
- Treatment with investigational product
- Treatment with PCSK9
- Clinically significant condition
- Known CETP inhibitor allergy
Data sourced from ClinicalTrials.gov (NCT05421078). 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.