Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

NewAmsterdam Pharma120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Dyslipidemias High Cholesterol Hypercholesterolemia

Interventions

ObicetrapibDRUG

tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (19)

Pinnacle Research Group

Anniston, Alabama, United States

National Research Institute - Huntington Park

Outcomes

Primary Outcomes

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),

Time frame: 8-weeks

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),

Time frame: 8-Weeks

LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),

Time frame: 8-Weeks

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame: 8-Weeks

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Data from ClinicalTrials.gov

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Secondary Outcomes

Mean Percent Change in Apolipoprotein B (ApoB)

Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

Time frame: 8-Weeks

Median Percent Change in Apolipoprotein B (ApoB)

Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

Time frame: 8-Week

LS Mean Percent Change in Apolipoprotein B (ApoB)

Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

Time frame: 8-Weeks

Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Time frame: 8-weeks

Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Time frame: 8-Weeks

LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Time frame: 8-Weeks

Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.

Time frame: 8-weeks

Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.

Time frame: 8-Weeks

LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.

Time frame: 8-Weeks