Obicetrapib for High Cholesterol

(BROADWAY Trial)

No longer recruiting at 205 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill, obicetrapib, to determine if it can lower bad cholesterol levels in individuals with high cholesterol due to genetic factors or heart disease. The trial compares obicetrapib to a placebo (a pill with no active ingredients) to assess its effectiveness and safety. Individuals with genetic high cholesterol or heart disease who are already on medications like statins but still require better cholesterol control may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the development of a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that obicetrapib is likely to be safe for humans?

Research has shown that obicetrapib is generally well-tolerated. One study compared obicetrapib to a placebo (a harmless pill with no active drug) and found a similar number of unwanted side effects in both groups. Another review of several studies found that obicetrapib has a good safety record, indicating it did not cause many serious side effects. However, researchers have not fully studied the safety of obicetrapib in all types of patients, so unknown risks may still exist. Overall, early findings suggest that obicetrapib is safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for high cholesterol, which typically involves statins like atorvastatin or rosuvastatin, obicetrapib works by inhibiting cholesteryl ester transfer protein (CETP). This mechanism is different because it aims to not only lower LDL cholesterol but also potentially increase HDL cholesterol, providing a twofold benefit. Researchers are excited about obicetrapib because it could offer an alternative for patients who cannot tolerate statins or need additional cholesterol-lowering effects beyond what statins can provide.

What evidence suggests that obicetrapib might be an effective treatment for high cholesterol?

Research has shown that obicetrapib, which participants in this trial may receive, effectively lowers bad cholesterol (LDL-C) levels. In studies, participants taking obicetrapib experienced a reduction in LDL-C by about 29.9% to 35.4%. It also increases good cholesterol (HDL-C) and reduces other harmful fats in the blood, making obicetrapib a promising option for people with high cholesterol, especially those at risk for heart problems. The treatment improves lipid profiles, which are important for heart health. ^{1 2 4 5 6}

Who Is on the Research Team?

Marc Ditmarsch

Principal Investigator

NewAmsterdam Pharma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40337982/

Safety and Efficacy of Obicetrapib in Patients at High ... The efficacy and safety of obicetrapib have not been fully characterized among patients at high risk for cardiovascular events. Methods: We ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1933287425003563

Updated meta-analysis of the lipid-lowering efficacy ... Results. Obicetrapib significantly improved lipid profiles. LDL-C decreased markedly (MD –35.4 mg/dL), especially at higher doses, particularly ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2025.07.056

Impact of Obicetrapib on Major Adverse Cardiovascular ... Obicetrapib is a highly selective and potent CETP inhibitor, with evidence of lowering levels of LDL-C, ApoB, and lipoprotein(a) [Lp(a)] and raising HDL-C, when ...

4. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2415820

Safety and Efficacy of Obicetrapib in Patients at High ... ... high risk for cardiovascular events, obicetrapib reduced LDL cholesterol levels by 29.9%. ... A data sharing statement provided by the ...

5. jwatch.org jwatch.org/na59194/2025/09/19/obicetrapib-and-cardiovascular-outcomes-early-insights

Obicetrapib and Cardiovascular Outcomes: Early Insights Compared with placebo, obicetrapib showed greater reductions in LDL-C and increases in HDL-C at 1 year. Patients who received obicetrapib ...

6. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00721-4/abstract

Fixed-dose combination of obicetrapib and ezetimibe for ... Obicetrapib monotherapy decreased LDL cholesterol by 31·9% (22·1 to 41·6) versus placebo. Adverse event rates were similar in the FDC (52 [51%] ...