Phase 2 Completed N=119 Randomized Quadruple-blind Treatment

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Dyslipidemias · High Cholesterol · Hypercholesterolemia

Source: ClinicalTrials.gov NCT05266586 ↗

Enrolled (actual)

119

Serious AEs

1.7%

Results posted

Jul 2024

Primary outcomePrimary: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald] — -0.83; -59.07 percent change from baseline — p=<.0001

Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, 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) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	-0.83; -59.07	<.0001 sig
PRIMARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	-6.35; -63.40	<.0001 sig
PRIMARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	-0.85; -59.23	<.0001 sig
PRIMARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	-1.49; -59.51	<.0001 sig
PRIMARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	-3.95; -62.80	<.0001 sig
PRIMARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	-1.54; -59.69	<.0001 sig
SECONDARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	-0.83; -39.35	<.0001 sig
SECONDARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	-6.35; -43.50	<.0001 sig
SECONDARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	-0.85; -39.20	<.0001 sig
SECONDARY Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]	-1.49; -39.04	<.0001 sig
SECONDARY Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]	-3.95; -43.55	<.0001 sig
SECONDARY LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]	-1.54; -38.75	<.0001 sig
SECONDARY Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo	0.51; -34.66	<.0001 sig
SECONDARY Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo	-2.05; -34.40	<.0001 sig
SECONDARY LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo	0.72; -34.95	<.0001 sig
SECONDARY Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo	0.51; -21.73	<.0001 sig
SECONDARY Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo	-2.05; -24.20	<.0001 sig
SECONDARY LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo	0.72; -21.56	<.0001 sig

Eligibility Criteria

Inclusion Criteria

LDL-C > 70 mg/dL and Triglycerides = 40 kg/m2
Significant cardiovascular disease
HbA1c >= 10%
Uncontrolled hypertension
Active muscle disease
estimated glomerular filtration rate < 60 mL/min
Hepatic dysfunction
History of participation in any clinical trial evaluating obicetrapib
Anemia
History of malignancy
Alcohol abuse
Treatment with investigational product
Treatment with PCSK9
Clinically significant condition
Known CETP inhibitor allergy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05266586). 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.