CLINICAL TRIALS PROFILE FOR EZETIMIBE

All Clinical Trials for EZETIMIBE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079638 ↗	Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL	Completed	Kos Pharmaceuticals	Phase 4	2004-04-01	The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
NCT00090298 ↗	Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-04-01	A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.
NCT00092573 ↗	Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-04-01	The purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
NCT00092599 ↗	Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-02-01	This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.
NCT00092560 ↗	Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-12-01	The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
NCT00092586 ↗	Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-09-01	The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.
NCT00045812 ↗	SCH-58235 (Ezetimibe) to Treat Homozygous Sitosterolemia	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2001-03-01	This study will test the safety and effectiveness of SCH-58235 (Ezetimibe) in lowering sitosterol, plant sterol and cholesterol blood levels in patients with homozygous sitosterolemia when added to the patients' current treatment regimen. Homozygous sitosterolemia is an inherited disorder of sterol metabolism in which an excess of many plant sterols, including sitosterol, is absorbed and not enough excreted. (Sterols are substances used to form hormones, vitamins and membranes found in animal and plant lipids.). Patients can develop atherosclerosis with coronary heart disease as early as childhood, as well as other problems including arthritis, arthralgia, and tendon xanthomas (lipid deposits). Current sitosterolemia treatments may include a low sterol diet, medications, intestinal surgery, or a combination of these. Ezetimibe is a member of a new class of drugs called "specific cholesterol absorption inhibitors" that may lower cholesterol, sitosterol and other plant sterol blood levels. Patients with homozygous sitosterolemia 10 years of age and older may be eligible for this study. Participants will have a medical history and physical examination and will be randomly assigned to one of two treatment groups. One group, which will include about 80 percent of all study participants, will take 10 mg of Ezetimibe a day, and the second group (20 percent of participants) will take a placebo (an inactive look-a-like pill). Patients will have 7 clinic visits during the 12-week study, when some or all of the following procedures and tests will be done: - Measurement of vital signs (heart rate, blood pressure, breathing rate and temperature) - Dietary maintenance - interview about how well that patient is adhering to the diet - Medication review - interview about other medications the patient is taking - Blood draw for tests - Urine sample for tests - Pregnancy test for women of childbearing potential - Electrocardiogram (ECG) to measure the electrical activity of the heart - Blood draw to determine sitosterol, other plant sterol levels, and lipid levels (cholesterol and other blood lipid concentrations) - Xanthoma measurement (with a ruler and X-ray of the foot)

Clinical Trial Conditions for EZETIMIBE

Condition Name

Condition Name for EZETIMIBE
Intervention	Trials
Hypercholesterolemia	140
Atherosclerosis	24
Hyperlipidemia	21
Coronary Artery Disease	17

Condition MeSH

Condition MeSH for EZETIMIBE
Intervention	Trials
Hypercholesterolemia	170
Coronary Artery Disease	48
Myocardial Ischemia	45
Coronary Disease	43

Clinical Trial Locations for EZETIMIBE

Trials by Country

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Trials by Country for EZETIMIBE
Location	Trials
United States	518
Canada	52
Korea, Republic of	48
China	43
United Kingdom	29

Trials by US State

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Trials by US State for EZETIMIBE
Location	Trials
California	28
Ohio	28
Texas	25
New York	24
North Carolina	23

Clinical Trial Progress for EZETIMIBE

Clinical Trial Phase

Clinical Trial Phase for EZETIMIBE
Clinical Trial Phase	Trials
Phase 4	117
Phase 3	123
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for EZETIMIBE
Clinical Trial Phase	Trials
Completed	240
Recruiting	35
Unknown status	26

Clinical Trial Sponsors for EZETIMIBE

Sponsor Name

Sponsor Name for EZETIMIBE
Sponsor	Trials
Merck Sharp & Dohme Corp.	118
Sanofi	15
Regeneron Pharmaceuticals	14

Sponsor Type

Sponsor Type for EZETIMIBE
Sponsor	Trials
Industry	264
Other	222
NIH	11

Ezetimibe: Clinical Trials, Market Analysis, and Projections

Introduction to Ezetimibe

Ezetimibe is a non-statin oral medication used to lower low-density lipoprotein cholesterol (LDL-C) levels, particularly in patients at high risk of cardiovascular disease (CVD). It works by inhibiting the absorption of cholesterol in the small intestine.

Current Clinical Trials

TANDEM Clinical Trial

One of the most significant ongoing clinical trials involving ezetimibe is the TANDEM trial conducted by NewAmsterdam Pharma. This Phase 3 trial evaluates the fixed-dose combination (FDC) of obicetrapib and ezetimibe in patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalents.

• Trial Design: The TANDEM trial is a double-blind, placebo-controlled study that enrolled 407 patients. The primary objective is to assess the effect of the FDC on LDL-C levels compared to ezetimibe and obicetrapib monotherapy and placebo. Secondary objectives include evaluating the effects on lipoprotein(a) (Lp(a)), apolipoprotein B (ApoB), and non-high-density lipoprotein cholesterol (non-HDL-C)[1][3][4].

• Enrollment and Data: Enrollment for the TANDEM trial has been completed, and the company expects to report topline data in the first quarter of 2025. This trial is part of NewAmsterdam Pharma's comprehensive Phase 3 program, which also includes the BROOKLYN, BROADWAY, and PREVAIL trials[1][3][4].

Market Analysis

Global Market Size and Growth

The global market for ezetimibe has been growing steadily. As of 2023, the market was estimated to be worth US$ 315 million. It is forecasted to reach US$ 460.8 million by 2030, with a compound annual growth rate (CAGR) of 6.1% during the forecast period of 2024-2030[2].

Market Segmentation

The ezetimibe market is segmented by type, application, and region. Key players in the market include Merck, Teva, Zydus Pharmaceuticals, Amneal Pharmaceuticals, and several others. The market analysis also includes revenue and volume forecasts, company shares, competitive landscapes, and growth factors and trends[2][5].

Combination Medications

Ezetimibe is often used in combination with other lipid-lowering therapies, such as statins (e.g., simvastatin, rosuvastatin) and other agents (e.g., bempedoic acid, atorvastatin). These combination medications are a significant segment of the market, with various manufacturers producing different combinations to cater to diverse patient needs[5].

Market Projections

Revenue and Volume Forecasts

The global ezetimibe combination medications market is expected to see substantial growth. The revenue share by application is forecasted to change between 2025 and 2030, with different regions such as the US, Canada, Europe, and Asia contributing to the overall growth. The market is also analyzed by type, with various combinations showing different growth rates[5].

Regional Analysis

The market is segmented by region, with detailed analyses of sales and revenue in the US, Canada, Europe, and Asia. These regions are further broken down into country-level data to provide a comprehensive view of the market's geographical distribution[5].

Key Players and Competitive Landscape

Major manufacturers of ezetimibe and its combination medications include Merck, Teva, Zydus Pharmaceuticals, Amneal Pharmaceuticals, Alkem Laboratories, APOTEX, Sandoz, Glenmark Pharmaceuticals, Mylan Pharmaceuticals, Aurobindo Pharma, and Accord Healthcare. The competitive landscape is characterized by these companies' market shares, product portfolios, and strategic initiatives[2][5].

Financial Guidance and Funding

NewAmsterdam Pharma, which is conducting several pivotal Phase 3 trials involving ezetimibe, believes its existing cash will be sufficient to fund operations through 2026, beyond the anticipated readout of its ongoing trials. This financial stability is crucial for the completion and success of these clinical programs[3].

Expert Insights and Quotes

Michael Davidson, M.D., Chief Executive Officer at NewAmsterdam Pharma, emphasized the significance of the TANDEM trial and the potential of the obicetrapib and ezetimibe combination:

"Supported by compelling data from our Phase 2 ROSE2 trial, which demonstrated meaningful reductions in LDL-C, non-HDL, and ApoB in patients already using high-intensity statin therapy, we believe the combination of obicetrapib, if approved, and ezetimibe, in a simple and convenient once-daily tablet, is highly synergistic, with the potential to significantly improve cardiovascular disease treatment for millions of people living with dyslipidemia."[1]

Safety and Tolerability

The TANDEM trial also evaluates the safety and tolerability profile of the obicetrapib and ezetimibe FDC. This is a critical aspect, as the combination's safety will be a key factor in its potential approval and adoption by healthcare providers[4].

Key Takeaways

• Clinical Trials: The TANDEM trial is a pivotal Phase 3 study evaluating the FDC of obicetrapib and ezetimibe, with topline data expected in the first quarter of 2025.
• Market Growth: The global ezetimibe market is projected to grow from US$ 315 million in 2023 to US$ 460.8 million by 2030, with a CAGR of 6.1%.
• Market Segmentation: The market is segmented by type, application, and region, with various combination medications being a significant segment.
• Competitive Landscape: Major players include Merck, Teva, and several other pharmaceutical companies.
• Financial Stability: NewAmsterdam Pharma has sufficient funding to support its clinical programs through 2026.

FAQs

What is the primary objective of the TANDEM clinical trial?

The primary objective of the TANDEM trial is to evaluate the effect of the fixed-dose combination of obicetrapib and ezetimibe on the change in LDL-C levels from baseline, compared to both ezetimibe and obicetrapib monotherapy and to placebo[1][3][4].

What is the forecasted market size of ezetimibe by 2030?

The global market for ezetimibe is forecasted to reach US$ 460.8 million by 2030[2].

Which companies are major players in the ezetimibe market?

Major players include Merck, Teva, Zydus Pharmaceuticals, Amneal Pharmaceuticals, Alkem Laboratories, APOTEX, Sandoz, Glenmark Pharmaceuticals, Mylan Pharmaceuticals, Aurobindo Pharma, and Accord Healthcare[2][5].

What is the expected CAGR of the ezetimibe market from 2024 to 2030?

The expected CAGR is 6.1% during the forecast period of 2024-2030[2].

When is the topline data from the TANDEM trial expected to be reported?

The topline data from the TANDEM trial is expected to be reported in the first quarter of 2025[1][3][4].

Sources

1. NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD. NewAmsterdam Pharma. Retrieved March 12, 2024.
2. Ezetimibe - Market, Report Size, Worth, Revenue, Growth, Industry. Valuates Reports. Retrieved 2024.
3. NewAmsterdam Pharma Announces 2024 Strategic Priorities. NewAmsterdam Pharma. Retrieved January 4, 2024.
4. NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib plus Ezetimibe in Patients with HeFH and/or ASCVD or ASCVD Risk Factors. NewAmsterdam Pharma.
5. Global Ezetimibe Combination Medications Market Insights. QYResearch. Retrieved October 30, 2024.