Clinical trial NCT05266586: Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemias
High Cholesterol
Hypercholesterolemia
Keywords: obicetrapib
statin
LDL-C
cholesterol
atherosclerosis
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled, double-blind, randomized
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

Eligibility criteria: Inclusion Criteria:

* LDL-C \> 70 mg/dL and Triglycerides \< 400 mg/dL,
* Treated with a high-intensity statin therapy

Exclusion Criteria:

* BMI \>= 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

Primary outcomes:
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
timeFrame: 12-weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
timeFrame: 12-Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
timeFrame: 12-Weeks
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
timeFrame: 12-Weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
timeFrame: 12-Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
timeFrame: 12-Weeks
Secondary outcomes:
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
timeFrame: 12-weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
timeFrame: 12-Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
timeFrame: 12-Weeks
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
timeFrame: 12-Weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
timeFrame: 12-Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
timeFrame: 12-Weeks
measure: Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
timeFrame: 12-weeks
measure: Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
timeFrame: 12-Weeks
measure: LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
timeFrame: 12-Weeks
measure: Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
timeFrame: 12-weeks
measure: Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
timeFrame: 12-Weeks
measure: LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
timeFrame: 12-Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Westlake d.b.a National Research Institute
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Ocala
country: United States
facility: Ocala Cardiovascular Research
state: Florida
city: Pembroke Pines
country: United States
facility: A & R Research Group, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research - Savannah, GA
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Addison
country: United States
facility: Biofortis, Inc
state: Illinois
city: Arlington Heights
country: United States
facility: Northwest Heart Clinical Research, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Owensboro
country: United States
facility: Research Integrity LLC
state: Kentucky
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Cincinnati
country: United States
facility: Meridian Clinical Research- Springdale, OH
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Munroe Falls
country: United States
facility: Summit Research Group, LLC
state: Ohio
Study officials:
affiliation: NewAmsterdam Pharma
name: Marc Ditmarsch
role: STUDY_DIRECTOR
References: