Randomized Study of Obicetrapib as an Adjunct to Statin Therapy (ROSE)

NewAmsterdam Pharma

Status and phase: Completed; Phase 2

Conditions: Dyslipidemias; Hypercholesterolemia; High Cholesterol

Treatments: Drug: Obicetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04753606

TA-8995-201

Details and patient eligibility

About

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.

Full description

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib 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, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• LDL-C > 70 mg/dL and TG < 400 mg/dL,
• Treated with a high-intensity statin therapy

Exclusion criteria

• BMI > 40 kg/m
• Significant cardiovascular disease
• HbA1c > 10%
• Uncontrolled hypertension
• Active muscle disease
• GFR < 60 ml/min
• Hepatic dysfunction
• 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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120 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

once-daily placebo

Treatment:

Drug: Obicetrapib

obicetrapib 5 mg

Experimental group

Description:

once-daily obicetrapib

Treatment:

Drug: Obicetrapib

obicetrapib 10 mg

Experimental group

Description:

once-daily obicetrapib

Treatment:

Drug: Obicetrapib