Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Phase 2

Completed

• Conditions: Dyslipidemias; High Cholesterol; Hypercholesterolemia
• Interventions: Drug: Obicetrapib

• Registration Number: NCT04753606
• Lead Sponsor: NewAmsterdam Pharma

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Study Start: 2021-02-18
• Primary Completion: 2021-05-24
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Results First Submitted: 2024-05-13
• Results First Submitted QC: 2024-06-10
• Results First Posted: 2024-06-11
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Obicetrapib	once-daily placebo
obicetrapib 5 mg	Obicetrapib	once-daily obicetrapib
obicetrapib 10 mg	Obicetrapib	once-daily obicetrapib

Primary Outcome Measures

Name	Time	Method
LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	8-Weeks	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),
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	8-Weeks	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).
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	8-weeks	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),
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	8-Weeks	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),
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	8-Weeks	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).
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	8-Weeks	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. LDL-C level was measured directly by preparative ultracentrifugation (PUC).

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	8-weeks	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
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	8-Weeks	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
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	8-Weeks	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
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	8-weeks	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.
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	8-Weeks	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.
Mean Percent Change in Apolipoprotein B (ApoB)	8-Weeks	Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
LS Mean Percent Change in Apolipoprotein B (ApoB)	8-Weeks	Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Median Percent Change in Apolipoprotein B (ApoB)	8-Week	Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	8-Weeks	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.

Trial Locations

Locations (19)

National Research Institute - Wilshire; 🇺🇸 Los Angeles, California, United States

Midwest Institute for Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

IACT Health; 🇺🇸 Columbus, Georgia, United States

Evanston Premier Healthcare Research LLC; 🇺🇸 Evanston, Illinois, United States

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Ocala Cardiovascular Research; 🇺🇸 Ocala, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Metabolic and Atherosclerosis Research Center; 🇺🇸 Cincinnati, Ohio, United States

Oakland Medical Research Center; 🇺🇸 Troy, Michigan, United States

Diabetes and Endocrinology Consultants, P.C.; 🇺🇸 Morehead City, North Carolina, United States

Lillestol Research, LLC; 🇺🇸 Fargo, North Dakota, United States

Summit Research Group, LLC; 🇺🇸 Munroe Falls, Ohio, United States

Health Concepts; 🇺🇸 Rapid City, South Dakota, United States

Manassas Clinical Research Center; 🇺🇸 Manassas, Virginia, United States

Juno Research, LL; 🇺🇸 Houston, Texas, United States

National Research Institute - Huntington Park; 🇺🇸 Huntington Park, California, United States

Monument Health Clinical Research; 🇺🇸 Rapid City, South Dakota, United States

Clinical Trials Research; 🇺🇸 Sacramento, California, United States