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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewAmsterdam Pharma

Criteria

Inclusion Criteria:

• 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 with additional risk factors

• Are on maximally tolerated lipid-modifying therapy, including a maximally tolerated statin, at a stable dose for at least 4 weeks prior to Screening

• Atorvastatin 40 or 80 mg; or

• Rosuvastatin 20 or 40 mg;

• Fasting serum LDL-C ≥70 and < 100 mg/dL (≥1.8 and <2.6 mmol/L) at Screening;

• Fasting triglyceride (TG) < 400 mg/dL (<4.52 mmol/L) at Screening; and

• Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min at Screening

Exclusion Criteria:

• New York Heart Association class IV heart failure or last known left ventricular ejection fraction < 25%;

• Major adverse cardiac event (MACE) within 3 months prior to Randomization;

• 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% 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 Screening;

• 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;

• 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