BROOKLYN: Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

Sponsor

NewAmsterdam Pharma (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05425745

Collaborator

(none)

300

Enrollment

Locations

Arms

24.2

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias High Cholesterol Hypercholesterolemia Familial Hypercholesterolemia Lipid Metabolism Disorder Metabolic Disease Lipid Metabolism, Inborn Errors Genetic Disease, Inborn Hyperlipoproteinemias	Drug: Obicetrapib Drug: Placebo	Phase 3

Detailed Description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards, patients will be randomized to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Placebo-Controlled, double-blind, randomizedPlacebo-Controlled, double-blind, randomized

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

placebo tablet made to resemble active

Primary Purpose:

Treatment

Official Title:

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH Who Are Not Adequately Controlled by Their Lipid Modifying Therapies

Actual Study Start Date :

Jul 25, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo one placebo tablet once daily	Drug: Placebo placebo tablet made to resemble active
Experimental: Obicetrapib 10 mg one 10 mg Obicetrapib tablet once daily	Drug: Obicetrapib 10 mg Obicetrapib tablet

Arm

Intervention/Treatment

Placebo Comparator: Placebo

one placebo tablet once daily

Drug: Placebo

placebo tablet made to resemble active

Experimental: Obicetrapib 10 mg

one 10 mg Obicetrapib tablet once daily

Drug: Obicetrapib

10 mg Obicetrapib tablet

Outcome Measures

Primary Outcome Measures

LDL-C [Percent change from baseline to Day 84 in LDL-C]
Obicetrapib compared to placebo on LDL-C

Secondary Outcome Measures

Apolipoprotein B (ApoB) [Percent change from baseline to Day 84 in ApoB]
obicetrapib compared to placebo on ApoB
non-HDL-C [Percent change from baseline to Day 84 in HDL-C]
obicetrapib compared to placebo on non-HDL-C
HDL-C [Percent change from baseline to Day 84 in HDL-C]
obicetrapib compared to placebo on HDL-C

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of > 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV 40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses)
Fasting serum LDL-C ≥70 and < 100 mg/dL (≥1.8 and <2.6 mmol/L)

Exclusion Criteria:

New York Heart Association class II or IV heart failure or last known 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;
HbA1c ≥10%, or fasting glucose
Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 01009	Sarasota	Florida	United States	34230
2	Site 01012	Iowa City	Iowa	United States	52240
3	Site 01007	Baton Rouge	Louisiana	United States	70809
4	Site 01005	Port Gibson	Mississippi	United States	39105
5	Site 01006	Saint Louis	Missouri	United States	63130
6	Site 01011	Lincoln	Nebraska	United States	68510
7	Site 01004	Norfolk	Nebraska	United States	68701
8	Site 01002	Morristown	New Jersey	United States	07960
9	Site 01010	New Providence	New Jersey	United States	07901
10	Site 01001	North Massapequa	New York	United States	11758
11	Site 01008	Chattanooga	Tennessee	United States	37405
12	Site 01013	Houston	Texas	United States	76706