Obicetrapib for High Cholesterol

(BROADWAY Trial)

Recruiting at 193 trial locations

Overseen By James Creager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NewAmsterdam Pharma

Must be taking: Statins, Ezetimibe, Bempedoic acid, PCSK-9

Must not be taking: Gemfibrozil

Disqualifiers: Heart failure, Hypertension, HoFH, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

2530 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of their current lipid-lowering medications, like statins, for at least 8 weeks before joining. You should not stop taking these medications if you want to participate.

What data supports the effectiveness of the drug Obicetrapib for high cholesterol?

Research shows that Obicetrapib, when used with high-intensity statins, significantly lowers bad cholesterol (LDL-C) and other harmful fats in the blood, while also increasing good cholesterol (HDL-C). This suggests it could be effective for people with high cholesterol who are at risk for heart disease. ^{1 2 3 4 5}

Is obicetrapib safe for humans?

Obicetrapib has been tested in clinical trials and showed an acceptable safety profile when used with high-intensity statins for patients with high cholesterol. ^{1 2 3 6 7}

How does the drug obicetrapib differ from other treatments for high cholesterol?

Obicetrapib is unique because it is a cholesteryl ester transfer protein (CETP) inhibitor that significantly lowers bad cholesterol (LDL-C) and increases good cholesterol (HDL-C) when added to high-intensity statin therapy, offering a new option for patients who do not achieve their cholesterol goals with statins alone. ^{1 2 3 5 8}

What is the purpose of this trial?

This trial is testing obicetrapib, a medication that helps lower bad cholesterol levels. It targets people with high cholesterol that isn't fully managed by their current treatments and diet. The medication works by reducing the amount of bad cholesterol in the blood, which can help prevent heart disease.

Research Team

Marc Ditmarsch

Principal Investigator

NewAmsterdam Pharma

Eligibility Criteria

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.

Inclusion Criteria

Your fasting triglyceride levels are within a certain range.

My cholesterol or other risk factors meet the study's criteria.

I have been on a stable dose of the highest statin dose I can tolerate for at least 4 weeks.

Exclusion Criteria

Your thyroid-stimulating hormone levels are higher than 1.5 times the normal limit.

Your blood sugar levels are very high, with HbA1c at 10% or fasting glucose at 270 mg/dL or more.

I have an ongoing liver condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants are randomized to receive either placebo or 10 mg obicetrapib daily for 365 days

52 weeks

Follow-up

Participants have an end of study follow-up visit to monitor safety and effectiveness

5 weeks

Treatment Details

Interventions

• Obicetrapib
• Placebo

Trial Overview 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.

Participant Groups

Group I: obicetrapib 10mg Experimental Treatment 1 Intervention

one 10mg obicetrapib tablet once daily

Group II: Placebo Placebo Group 1 Intervention

one placebo tablet once daily

Who Is Running the Clinical Trial?

NewAmsterdam Pharma

Lead Sponsor

Trials

17

Recruited

13,900+

Findings from Research

In a phase 2 trial with 97 patients, the combination of obicetrapib and ezetimibe significantly reduced LDL cholesterol levels by 63.4% compared to only 6.35% in the placebo group, demonstrating strong lipid-altering efficacy.

Obicetrapib was well tolerated with no safety issues reported, indicating that it is a safe adjunct therapy when added to high-intensity statin treatment for patients with elevated LDL cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obicetrapib plus ezetimibe as an adjunct to high-intensity statin therapy: A randomized phase 2 trial. Ballantyne, CM., Ditmarsch, M., Kastelein, JJ., et al.[2023]

In a randomized, double-blind, placebo-controlled trial involving 120 dyslipidaemic patients, the CETP inhibitor obicetrapib significantly reduced LDL cholesterol levels by up to 51% over 8 weeks when added to high-intensity statin therapy.

Obicetrapib also decreased apolipoprotein B and non-HDL cholesterol levels while increasing HDL cholesterol by up to 165%, demonstrating its potential as an effective treatment for high-cardiovascular-risk patients with an acceptable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nicholls, SJ., Ditmarsch, M., Kastelein, JJ., et al.[2022]

In a study of 850 patients with familial hypercholesterolemia, adding torcetrapib to atorvastatin significantly increased HDL cholesterol levels but did not improve the progression of atherosclerosis, as measured by carotid intima-media thickness.

The combination therapy actually led to a worsening in the common carotid artery's thickness, indicating that despite lowering LDL cholesterol and raising HDL cholesterol, torcetrapib did not provide the expected cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. Kastelein, JJ., van Leuven, SI., Burgess, L., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Obicetrapib plus ezetimibe as an adjunct to high-intensity statin therapy: A randomized phase 2 trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Safety of anacetrapib in patients with or at high risk for coronary heart disease. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

No clinically relevant drug-drug interactions when dalcetrapib is co-administered with a monophasic oral contraceptive (Microgynon® 30). [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of dalcetrapib. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A Multiregional, Randomized Evaluation of the Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients With Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Will torcetrapib be the next big thing in coronary heart disease risk reduction? [2019]