A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

NewAmsterdam Pharma

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia; Dyslipidemia; High Cholesterol

Treatments: Drug: Placebo; Drug: Obicetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05421078

TA-8995-203

Details and patient eligibility

About

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable 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 stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 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 visit.

Enrollment: 102 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 stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20

Exclusion criteria

• BMI > or =35 kg/m2
• Significant cardiovascular disease
• HbA1c > 10%
• Uncontrolled hypertension
• Active muscle disease
• GFR < 60 ml/min
• Hepatic dysfunction
• Anemia
• Existing CETP deficiency
• History of Homozygous Familial Hypercholerstrolemia
• 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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102 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Once-daily placebo

Treatment:

Drug: Placebo

2.5 mg Obicetrapib

Experimental group

Description:

once-daily Obicetrapib

Treatment:

Drug: Obicetrapib

5 mg Obicetrapib

Experimental group

Description:

once-daily Obicetrapib

Treatment:

Drug: Obicetrapib

10 mg Obicetrapib

Experimental group

Description:

once-daily Obicetrapib

Treatment:

Drug: Obicetrapib