← Back to Search

Obicetrapib for High Cholesterol (BROADWAY 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
Are on maximally tolerated lipid-modifying therapy including statins, ezetimibe, bempedoic acid, or PCSK-9 targeted therapy
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
Must not have
Active liver disease
Uncontrolled severe hypertension with specified blood pressure ranges
Timeline
Screening 3 weeks
Treatment Varies
Follow Up percent change from baseline to day 84, day 180, and day 365 in tc
Awards & highlights

Summary

This trial will study whether obicetrapib is effective and safe in people with familial hypercholesterolemia or ASCVD.

Who is the study for?
This trial is for adults with high cholesterol or heart disease who are already on the highest dose of cholesterol-lowering meds they can handle. They should have a specific genetic condition (HeFH) or a history of cardiovascular disease, and their kidneys must work well. Pregnant or breastfeeding women, or those planning to become pregnant during the study, cannot participate.Check my eligibility
What is being tested?
The trial is testing Obicetrapib's effectiveness when added to existing treatments for lowering cholesterol compared to a placebo. It's in phase 3, meaning it's closer to potentially being approved if results are positive. Participants won't know whether they're getting the real drug or a dummy pill.See study design
What are the potential side effects?
While not specified here, common side effects from drugs like Obicetrapib may include digestive issues, muscle pain or weakness, liver problems which might show up as fatigue or yellowing skin/eyes, and increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking the highest dose of cholesterol medication that I can tolerate.
Select...
I've been on the highest dose of cholesterol medication I can handle for at least 8 weeks.
Select...
I have a genetic condition that causes high cholesterol or a history of heart disease.
Select...
My LDL cholesterol levels fall within the required range.
Select...
I am currently taking Atorvastatin or Rosuvastatin at the specified doses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an ongoing liver condition.
Select...
My blood pressure is very high and not under control.
Select...
My heart's pumping ability is severely reduced.
Select...
I have been diagnosed with homozygous familial hypercholesterolemia.
Select...
I was hospitalized for heart failure within the last 5 years.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Apolipoprotein A1 (ApoA1)
HDL-C
LDL-C
+5 more
Other outcome measures
Cardiovascular hospitalizations
Major adverse cardiac event (MACE)

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT04753606
5%
Hypertension
5%
Fatigue
5%
Type 2 diabetes mellitus
3%
Dizziness
3%
Pyrexia
3%
Rhinitis allergic
3%
Constipation
3%
Nausea
3%
Lipase increased
3%
Urinary tract infection
3%
Arthralgia
3%
Rhinorrhoea
3%
Back pain
3%
Polycythaemia
3%
Blood creatine phosphokinase increased
3%
Fall
3%
Vision blurred
3%
Arthritis
3%
Vaccination complication
3%
Ovarian cyst
3%
Epicondylitis
3%
Toothache
3%
Visual acuity reduced
3%
Headache
3%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Obicetrapib 5 mg
Obicetrapib 10 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: obicetrapib 10mgExperimental Treatment1 Intervention
one 10mg 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high cholesterol include statins, ezetimibe, PCSK9 inhibitors, and CETP inhibitors. Statins work by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis, thereby lowering LDL-C levels. Ezetimibe reduces cholesterol absorption in the intestines. PCSK9 inhibitors increase the number of LDL receptors on liver cells, enhancing the clearance of LDL-C from the bloodstream. CETP inhibitors, such as Obicetrapib, raise HDL-C levels and lower LDL-C levels by inhibiting the protein that transfers cholesteryl esters from HDL to LDL particles. These mechanisms are crucial for high cholesterol patients as they help reduce the risk of cardiovascular events by effectively managing and lowering harmful cholesterol levels.
New Approaches in Detection and Treatment of Familial Hypercholesterolemia.Cholesteryl ester transfer protein (CETP) deficiency and CETP inhibitors.

Find a Location

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
11,181 Total Patients Enrolled
6 Trials studying High Cholesterol
1,159 Patients Enrolled for High Cholesterol
Marc DitmarschStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
527 Total Patients Enrolled
3 Trials studying High Cholesterol
527 Patients Enrolled for High Cholesterol

Media Library

Obicetrapib Clinical Trial Eligibility Overview. Trial Name: NCT05142722 — Phase 3
High Cholesterol Research Study Groups: Placebo, obicetrapib 10mg
High Cholesterol Clinical Trial 2023: Obicetrapib Highlights & Side Effects. Trial Name: NCT05142722 — Phase 3
Obicetrapib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142722 — Phase 3
High Cholesterol Patient Testimony for trial: Trial Name: NCT05142722 — Phase 3
~707 spots leftby Jul 2025