CLINICAL TRIALS PROFILE FOR GEMFIBROZIL

All Clinical Trials for Gemfibrozil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000461 ↗	Harvard Atherosclerosis Reversibility Project (HARP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1986-12-01	To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	Hennepin County Medical Center, Minneapolis	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00039663 ↗	Endothelial Dysfunction as a Risk Factor in HIV Study	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2002-05-01	Highly active antiretroviral therapy (HAART) has proven effective in altering the natural history of HIV infection in many patients. However, this therapy may not be sustainable because of the toxicities of the medications. Evidence suggests that HIV-infected patients on HAART may be at risk for premature coronary artery disease. The exact cause is unknown. It is possible that the medications directly affect the endothelium (the lining of the arteries that supply blood to the heart) and lead to premature heart disease. Or because the medications cause lipid abnormalities (high cholesterol) and a condition of relative insulin resistance, in which the body has a difficult time processing sugars; known risk factors for endothelial dysfunction and heart disease. Therapeutic intervention that reverses these lipid abnormalities and/or insulin resistance may lower these risk factors, normalize endothelial function, and decrease the risk of heart disease. This protocol aims to assess endothelial function among a group of HIV-infected patients with varying degrees of viral activity and levels of immune function on a variety of HAART regimens. It also aims to evaluate the effect of three different medications on lipids, insulin resistance, and thus endothelial function. Understanding the factors involved in causing endothelial dysfunction will help better characterize the relative risks and benefits of early versus late and continuous versus intermittent HAART therapy. The research may offer some insights into the causes of premature heart disease among HIV-infected patients on HAART that could be more thoroughly investigated in subsequent clinical trials. A total of 75 patients will be recruited: 25 for each arm of the study. Each arm evaluates the potential benefit of a particular medication and will enroll sequentially. An endothelial function test will be performed on an outpatient basis. The first 25 patients will be assigned at random to receive pravastatin sodium or placebo; the next 25 will receive gemfibrozil or placebo; the final 25 will receive rosiglitazone or placebo. Patients will take the pills for 6 weeks, no pills for the next 4 weeks, and then the opposite treatment for 6 more weeks. Two weeks after the start of the study drug, blood will be taken to check for potential toxic side effects. After each 6-week treatment, blood will be drawn and endothelial function tests will be performed.
NCT00108511 ↗	Effect of Gemfibrozil on Serum Glycosylphosphatidylinositol (GPI) Phospholipase D and Triglycerides	Completed	US Department of Veterans Affairs	Phase 1	2004-10-01	The purpose of this study is to examine the role of glycosylphosphatidylinositol-specific phospholipase D (GPI-PLD) in triglyceride metabolism.

Clinical Trial Conditions for Gemfibrozil

Condition Name

Condition Name for Gemfibrozil
Intervention	Trials
Healthy Subjects	5
Hypertriglyceridemia	3
Healthy	3
Healthy Volunteers	3

Condition MeSH

Condition MeSH for Gemfibrozil
Intervention	Trials
Hypertriglyceridemia	4
Diabetes Mellitus, Type 2	4
Dyslipidemias	3
Diabetes Mellitus	3

Clinical Trial Locations for Gemfibrozil

Trials by Country

Trials by Country for Gemfibrozil
Location	Trials
United States	62
Canada	11
Germany	2
United Kingdom	2
Netherlands	1

Trials by US State

Trials by US State for Gemfibrozil
Location	Trials
Texas	5
Florida	4
Maryland	4
Minnesota	4
Ohio	3

Clinical Trial Progress for Gemfibrozil

Clinical Trial Phase

Clinical Trial Phase for Gemfibrozil
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	5
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Gemfibrozil
Clinical Trial Phase	Trials
Completed	32
Recruiting	3
Terminated	3

Clinical Trial Sponsors for Gemfibrozil

Sponsor Name

Sponsor Name for Gemfibrozil
Sponsor	Trials
GlaxoSmithKline	4
National Institutes of Health Clinical Center (CC)	3
VA Office of Research and Development	2

Sponsor Type

Sponsor Type for Gemfibrozil
Sponsor	Trials
Industry	31
Other	22
NIH	6

Gemfibrozil: Clinical Trials, Market Analysis, and Projections

Introduction

Gemfibrozil is a fibric acid derivative used primarily to lower triglyceride levels and increase high-density lipoprotein (HDL) cholesterol in the blood. It is a crucial medication in the management of dyslipidemia and the prevention of cardiovascular events. Here, we will delve into the current status of clinical trials involving gemfibrozil, analyze the market trends, and provide projections for its future use.

Clinical Trials Update

Ongoing and Completed Trials

Several clinical trials have been conducted or are ongoing to assess the efficacy and safety of gemfibrozil in various contexts.

• Cardiovascular Health: The VA-HIT (Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial) study demonstrated that gemfibrozil significantly reduces major cardiovascular events in patients with low HDL-C levels and low LDL-C levels. The study showed a 22% reduction in the relative risk of nonfatal myocardial infarction and CHD death[3].
• Pharmacokinetics: A Phase I trial by AstraZeneca investigated the effect of gemfibrozil on the pharmacokinetics of rosuvastatin in healthy men and women. This trial aimed to understand the drug interactions between gemfibrozil and other statins[4].
• Batten Disease: Although not directly related to its primary use, gemfibrozil is being explored in the treatment of Batten disease. For example, Polaryx Therapeutics is conducting a Phase 3 trial using gemfibrozil (PLX-200) for CLN3, a subtype of Batten disease. However, there has been no update on this trial since November 2020[1].

Current Status and Future Directions

• Gemfibrozil in Batten Disease: The use of gemfibrozil in Batten disease is an area of ongoing research, but the lack of recent updates suggests that this avenue may not be as actively pursued as other treatments.
• Cardiovascular Trials: The VA-HIT study and similar trials have established gemfibrozil's efficacy in cardiovascular health. However, new trials are not frequently initiated for this indication, as the drug's benefits are well-documented.

Market Analysis

Global Market Size and Trends

The global fibrate drugs market, which includes gemfibrozil, is expected to grow significantly over the next decade.

• Market Size: The global fibrate drugs market is projected to reach USD 5.04 billion by 2032, according to a report by Polaris Market Research. This growth is driven by increasing awareness of cardiovascular health and the need for effective lipid-lowering therapies[2].
• Segmentation: The market is segmented by drug type, product type, form, distribution channel, and region. Gemfibrozil, along with other fibrates like clofibrate and fenofibrate, constitutes a significant portion of this market[2].

Gemfibrozil API Market

The active pharmaceutical ingredient (API) market for gemfibrozil is also experiencing growth.

• Market Size and Growth: The global gemfibrozil API market is analyzed in terms of market size, trends, and demand forecasts. The market is expected to grow due to increasing demand for gemfibrozil in various regions, with a focus on purity levels (e.g., ≥ 98% and ≥ 99%)[5].
• Regional Analysis: The market is broken down by region, including the US, Canada, Europe, China, and other areas. This segmentation helps in understanding the regional demand and supply dynamics[5].

Projections and Future Outlook

Market Projections

• Growth Rate: The global gemfibrozil API market is expected to grow at a significant compound annual growth rate (CAGR) from 2023 to 2030. This growth is driven by the increasing prevalence of cardiovascular diseases and the need for effective treatments[5].
• Regional Expansion: The market is expected to expand in regions with growing healthcare infrastructure and increasing awareness of cardiovascular health. Emerging markets in Asia, Africa, and Latin America are likely to contribute significantly to this growth[5].

Clinical and Therapeutic Projections

• Cardiovascular Health: Gemfibrozil will continue to play a crucial role in the management of dyslipidemia and the prevention of cardiovascular events. Its cost-effectiveness, as demonstrated by studies like the VA-HIT trial, makes it a valuable option in healthcare settings[3].
• Exploratory Uses: Although the use of gemfibrozil in Batten disease is not as prominent, ongoing research may uncover new therapeutic applications for this drug.

Cost-Effectiveness

Gemfibrozil has been shown to be cost-effective in the treatment of coronary heart disease (CHD) patients with low HDL-C levels.

• Lifetime Cost Savings: Studies have indicated that gemfibrozil therapy can result in lifetime cost savings. For example, using VA prices, gemfibrozil was found to be cost-saving, with a net lifetime cost savings of $110 per patient[3].
• Quality-Adjusted Life Years: The cost per quality-adjusted life year (QALY) saved by gemfibrozil therapy is well below the threshold considered cost-effective, making it a valuable therapeutic option in terms of both health outcomes and economic impact[3].

Key Takeaways

• Clinical Trials: Gemfibrozil has been extensively studied for its cardiovascular benefits, with ongoing research exploring its use in other conditions like Batten disease.
• Market Growth: The global fibrate drugs market and the gemfibrozil API market are expected to grow significantly over the next decade.
• Cost-Effectiveness: Gemfibrozil is a cost-effective treatment for CHD patients, offering both health and economic benefits.
• Future Outlook: The drug will continue to be a valuable option in cardiovascular health management and may see expanded use in other therapeutic areas.

FAQs

What is the primary use of gemfibrozil?

Gemfibrozil is primarily used to lower triglyceride levels and increase HDL cholesterol in the blood, helping to manage dyslipidemia and prevent cardiovascular events.

What are the key findings of the VA-HIT study?

The VA-HIT study demonstrated that gemfibrozil reduces major cardiovascular events in patients with low HDL-C levels and low LDL-C levels, showing a 22% reduction in the relative risk of nonfatal myocardial infarction and CHD death.

Is gemfibrozil cost-effective?

Yes, gemfibrozil has been shown to be cost-effective in the treatment of CHD patients, resulting in lifetime cost savings and a low cost per QALY saved.

What is the current status of gemfibrozil in Batten disease treatment?

Gemfibrozil is being explored in the treatment of Batten disease, but there have been no recent updates on the Phase 3 trial by Polaryx Therapeutics, suggesting this avenue may not be as actively pursued.

What are the market projections for gemfibrozil?

The global gemfibrozil API market is expected to grow significantly over the next decade, driven by increasing demand for lipid-lowering therapies and expanding healthcare infrastructure in various regions.

Sources

1. Clinical Trials & Natural History Studies - BDSRA Foundation
2. Fibrate Drugs Market Share, Size, Trends, Industry Analysis Report - Polaris Market Research
3. Cost-effectiveness of Gemfibrozil for Coronary Heart Disease - JAMA Internal Medicine
4. A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Trial - AstraZeneca Clinical Trials
5. Global Gemfibrozil API Market Insights, Forecast to 2030 - QYResearch