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Cholesteryl Ester Transfer Protein (CETP) Inhibitor

Obicetrapib for High Cholesterol (BROOKLYN Trial)

Phase 3
Waitlist Available
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of heterozygous familial hypercholesterolemia (HeFH) by 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up percent change from baseline to day 84, 180, and 365 in apob
Awards & highlights

BROOKLYN Trial Summary

This trial will study whether the drug obicetrapib is effective in treating people with a history of HeFH, a condition that causes high cholesterol. The trial will be placebo-controlled, meaning some participants will receive a placebo, and double-blind, meaning neither the participants nor the researchers will know who is receiving the drug or the placebo.

Who is the study for?
This trial is for people with a genetic condition called heterozygous familial hypercholesterolemia (HeFH) who have high LDL cholesterol levels despite taking the maximum tolerated dose of lipid-modifying therapies. They must meet specific criteria based on their genetics and clinical history, but can't join if they have severe heart issues, uncontrolled diabetes or hypertension.Check my eligibility
What is being tested?
The study tests Obicetrapib's effectiveness in lowering cholesterol compared to a placebo. Participants will be randomly assigned to either receive Obicetrapib or a placebo without knowing which one they're getting, ensuring the results are unbiased.See study design
What are the potential side effects?
While the side effects of Obicetrapib aren't detailed here, similar medications often cause digestive discomfort, muscle pain or weakness, liver enzyme changes, and increased blood sugar levels.

BROOKLYN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed diagnosis of familial hypercholesterolemia.
Select...
I've been on the highest dose of cholesterol medication I can tolerate for 8 weeks.

BROOKLYN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~percent change from baseline to day 84, 180, and 365 in apob
This trial's timeline: 3 weeks for screening, Varies for treatment, and percent change from baseline to day 84, 180, and 365 in apob for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Apolipoproteins B
HDL-C
Low Density Lipoprotein-Cholesterol (LDL-C)
+4 more

BROOKLYN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Obicetrapib 10 mgExperimental Treatment1 Intervention
one 10 mg Obicetrapib tablet once daily
Group II: PlaceboPlacebo Group1 Intervention
one placebo tablet once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
2022
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
12,872 Total Patients Enrolled
6 Trials studying High Cholesterol
3,391 Patients Enrolled for High Cholesterol
Marc DitmarschStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
2,759 Total Patients Enrolled
3 Trials studying High Cholesterol
2,759 Patients Enrolled for High Cholesterol

Media Library

Obicetrapib (Cholesteryl Ester Transfer Protein (CETP) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05425745 — Phase 3
High Cholesterol Research Study Groups: Placebo, Obicetrapib 10 mg
High Cholesterol Clinical Trial 2023: Obicetrapib Highlights & Side Effects. Trial Name: NCT05425745 — Phase 3
Obicetrapib (Cholesteryl Ester Transfer Protein (CETP) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425745 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide the latest numbers regarding how many people are enrolled in this medical study?

"To move forward with this research, we need 300 individuals that meet the pre-determined criteria. These potential participants can come from various locations, such as Site 01005 in Port Gibson, Mississippi or DiGiovanna Institute for Medical Education and Research in North Massapequa, New york."

Answered by AI

Are there any available positions for candidates in this clinical trial?

"Yes, the trial is still recruiting patients. According to information on clinicaltrials.gov, this study was first posted on July 25th, 2022 and updated most recently on September 27th of the same year. They are looking for 300 participants across 14 sites."

Answered by AI

Where is this trial being conducted?

"Currently, this study is running at 14 sites. The locations are based in Port Gibson, North Massapequa and Morristown to name a few other locations. It is helpful to select the clinic nearest you to minimize travel demands if you enroll."

Answered by AI

Has the drug Obicetrapib been cleared by the FDA?

"Obicetrapib has received a score of 3 for safety. This is because it is a Phase 3 trial, which suggests that not only does some data support its efficacy, but multiple rounds of testing have shown it to be safe."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
North Carolina
Illinois
How old are they?
65+
What site did they apply to?
Overlook Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
2022. "Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425745.
All > Cholesterol
~37 spots leftby Jul 2024
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