Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Completed · Phase 3 · Has a placebo group

Conditions studied: Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease

In brief

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy

Key facts

Study ID

NCT05142722

Run by

NewAmsterdam Pharma

People needed

2530

Starts

2021-12-15

Expected to finish

2024-09-26

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females may be enrolled if all 3 of the following criteria are met:
• They are not pregnant;
• They are not breastfeeding; and
• They do not plan on becoming pregnant during the study;
• Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD
• Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows:
• A statin at a maximally tolerated stable dose for at least 8 weeks prior to Screening
• Atorvastatin 40 and 80 mg; and
• Rosuvastatin 20 and 40 mg;
• Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening
• Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening
• A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening
• Have a fasting serum LDL-C at Screening as follows:
• Fasting serum LDL-C ≥ 55 to < 100 mg/dL (≥1.4 to <2.6 mmol/L) OR non-HDL-C ≥85 mg/dL (≥2.2 mmol/L) to < 130 mg/dL (<3.4 mmol/L) with at least 1 of the following risk enhancers at Screening;
• Recent MI (> 3 and < 12 months prior to Randomization);
• Type 2 diabetes mellitus;
• Current daily cigarette smoking;
• Age of > 60 years;
• High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L (≥19.0 nmol/L) at Screening or within 6 months prior to Screening
• Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L);
• Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or
• Fasting HDL-C < 40 mg/dL (<1.0 mmol/L); OR
• Fasting serum LDL-C ≥ 100 mg/dL (≥2.6 mmol/L) or non-HDL-C ≥130 mg/dL (≥3.4 mmol/L)
• Fasting triglyceride (TG) < 500 mg/dL (<5.7 mmol/L) at Screening; and
• Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening

You may not qualify if…

• New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%;
• Hospitalized for heart failure within 5 years prior to Screening
• Major adverse cardiac event (MACE) within 3 months prior to Screening;
• Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization;
• Formal diagnosis of homozygous familial hypercholesterolemia (HoFH);
• Active liver disease;
• HbA1c ≥10% or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening;
• Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN) at Screening;
• Creatine kinase > 3 X upper limit of normal (ULN) at Screening;
• History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization;
• Known history of alcohol and/or drug abuse within 5 years prior to Randomization
• Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer;
• Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
• Planned use of other investigational products or devices during the course of the study;
• Participated in any clinical trial evaluating obicetrapib; or
• Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
• Any condition that, according to the Investigator, could interfere with the conduct of the study

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Central Alabama Research — Birmingham, Alabama, United States
• Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC — Birmingham, Alabama, United States
• The Center for Clinical Trials, Inc — Saraland, Alabama, United States
• Syed Research Consultants, LLC — Sheffield, Alabama, United States
• Clinical Research Institute of Arizona, LLC — Sun City West, Arizona, United States
• Synexus Clinical Research US, Inc. / Orange Grove Family Practice — Tucson, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• American Institute of Research — Beverly Hills, California, United States
• Orange County Research Center — Tustin, California, United States
• Synexus Clinical Research US, Inc. — Vista, California, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Pioneer Clinical Studies — Ft. Pierce, Florida, United States
• New Generation of Medical Research — Hialeah, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• East Coast Institute for Research, LLC - Jacksonville University Blvd — Jacksonville, Florida, United States
• East Coast Institute for Research- Lake City — Lake City, Florida, United States
• ClinCloud LLC — Maitland, Florida, United States
• Columbus Clinical Services, LLC — Miami, Florida, United States
• Kendall South Medical Center, Inc. — Miami, Florida, United States
• Advanced Research Institute Inc — New Port Richey, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• East Coast Institute for Research — Saint Augustine, Florida, United States
• Synexus Clinical Research US, Inc. — The Villages, Florida, United States
• Lishui Central Hospital — Lishui, China

Full record on ClinicalTrials.gov

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