Phase 3 N=407 Randomized Quadruple-blind Treatment

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Dyslipidemias · Hypercholesterolemia · Familial Hypercholesterolemia · ASCVD · High Cholesterol

Bottom Line

View on ClinicalTrials.gov: NCT06005597 ↗

Enrolled (actual)

407

Serious AEs

4.9%

Results posted

Oct 2025

Primary outcome: Primary: Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C — -45.58; 3.03 percent change from baseline — p=<.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Combination Therapy (Combination_product); Monotherapy obicetrapib (Drug); Monotherapy ezetimibe (Drug); Combination Therapy placebo (Other); Obicetrapib Placebo (Other); Ezetimibe Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NewAmsterdam Pharma
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C	-45.58; 3.03	<.0001 sig
PRIMARY Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C	-45.58; -17.63	<.0001 sig
PRIMARY Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C	-45.58; -28.82	0.0007 sig
PRIMARY Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C	-28.82; 3.03	<.0001 sig
SECONDARY Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C	-42.42; 2.71	<.0001 sig
SECONDARY Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)	-26.91; 2.28	<.0001 sig
SECONDARY Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C	-27.19; 2.71	<.0001 sig
SECONDARY Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)	-17.50; 2.28	<.0001 sig
SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C	-42.42; -16.98	<.0001 sig
SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)	-26.91; -12.71	<.0001 sig
SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C	-42.42; -27.19	0.0003 sig
SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)	-26.91; -17.50	0.007 sig

Summary

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

Eligibility Criteria

Inclusion Criteria

Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
LDL-C ≥ 70 mg/dL
Triglycerides 1.5 x upper limit of normal (ULN)
History of malignancy
Creatinine kinase (CK) >3 X ULN
Alcohol abuse
Treatment with investigational product
Treatment with gemfibrozil or ezetimibe
Previous participation in a trial evaluating obicetrapib
Known allergy to study drugs, placebo or excipients in study drugs of placebo
Other condition that would interfere with the conduct of the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06005597). 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.