Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy (ROSE2)

NewAmsterdam Pharma

Status and phase: Completed; Phase 2

Conditions: Dyslipidemias; Hypercholesterolemia; High Cholesterol

Treatments: Other: Obicetrapib placebo; Drug: Ezetimibe 10mg; Other: Ezetimibe placebo; Drug: Obicetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05266586

TA-8995-202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

once-daily placebo tablet and placebo capsule

Treatment:

Other: Ezetimibe placebo

Other: Obicetrapib placebo

monotherapy

Experimental group

Description:

once-daily obicetrapib 10 mg tablet and placebo capsule

Treatment:

Drug: Obicetrapib

Other: Ezetimibe placebo

combination therapy

Experimental group

Description:

once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

Treatment:

Drug: Obicetrapib

Drug: Ezetimibe 10mg