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

Hypercholesterolemia Clinical Trial

— ROSE2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266586
• Other study ID #: TA-8995-202
• Status: Completed
• Phase: Phase 2
• Start date: March 9, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2022
• Source: NewAmsterdam Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 8, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia

Intervention

Drug:
• Obicetrapib
tablets
• Ezetimibe 10mg
capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Other:
• Obicetrapib placebo
tablets; no active ingredient
• Ezetimibe placebo
capsules; no active ingredient

Locations

Country	Name	City	State
United States	Biofortis, Inc	Addison	Illinois
United States	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois
United States	Mercury Street Medical	Butte	Montana
United States	Meridian Clinical Research- Springdale, OH	Cincinnati	Ohio
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Velocity Clinical Research - Westlake d.b.a National Research Institute	Los Angeles	California
United States	Velocity Clinical Research	Meridian	Idaho
United States	Summit Research Group, LLC	Munroe Falls	Ohio
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Ocala Cardiovascular Research	Ocala	Florida
United States	Research Integrity LLC	Owensboro	Kentucky
United States	A & R Research Group, LLC	Pembroke Pines	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Meridian Clinical Research - Savannah, GA	Savannah	Georgia
United States	Oakland Medical Research Center	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
NewAmsterdam Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of combination therapy compared with placebo on LDL-C	Percent change in LDL-C	12-weeks
Secondary	Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C	Percent change in LDL-C	12-weeks
Secondary	Effect combination therapy compared with placebo on ApoB	Percent change in ApoB	12-weeks
Secondary	Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB	Percent change in ApoB	12-weeks