CLINICAL TRIALS PROFILE FOR CLOFIBRATE

All Clinical Trials for clofibrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000482 ↗	Coronary Drug Project	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1965-04-01	To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.
NCT00000483 ↗	Coronary Drug Project Mortality Surveillance	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	1981-06-01	To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
NCT00238004 ↗	The Low HDL On Six Weeks Statin Therapy (LOW) Study	Unknown status	Craigavon Area Hospital	Phase 4	2005-11-01	Abnormal blood cholesterol levels increase the risk of developing, or dying from heart disease. It is well recognised that if "harmful" LDL cholesterol is high, and "protective" HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol levels. However, statins only increase protective HDL cholesterol to a small extent. Some patients may thus benefit from additional medication to increase protective HDL-cholesterol further. One of the most effective drugs which can do this is nicotinic acid. This drug is well established having been available for over 30 years. Previous use has been limited by facial flushing in a large percentage of patients receiving the drug. However a new formulation called Niaspan is now available which is associated with much less flushing. Although many patients will have transient flushing, it is estimated that only 1 patient out of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in patients with coronary artery disease and low HDL cholesterol despite being on a statin, to study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its tolerability.
NCT00311987 ↗	Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients	Terminated	Johns Hopkins University	Phase 1/Phase 2	2006-04-01	The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions on other organs, including the heart, bone, and brain, where there can be side effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor expressed in the liver, where it regulates several aspects of lipid metabolism, including the clearance of low-density lipoprotein (LDL) cholesterol. This study is designed to determine whether DITPA is safe and effective in achieving LDL cholesterol levels that are consistent with the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels on conventional therapy, due to drug-resistant disease, drug intolerance, or both. This is a single-center, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for a total treatment duration of 12 weeks. Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20 patients per treatment group): - DITPA at 90 mg/day (45 mg twice a day [BID] taken orally) - DITPA at 180 mg/day (90 mg BID taken orally) - Placebo (BID taken orally) Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for 10 weeks. Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.
NCT00983788 ↗	Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects	Completed	Groupe Hospitalier Pitie-Salpetriere	Phase 2	2009-10-01	The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).

Clinical Trial Conditions for clofibrate

Condition Name

Condition Name for clofibrate
Intervention	Trials
Myocardial Infarction	2
Cardiovascular Diseases	2
Myocardial Ischemia	2
Coronary Disease	2

Condition MeSH

Condition MeSH for clofibrate
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	3
Cardiovascular Diseases	2
Myocardial Infarction	2

Clinical Trial Locations for clofibrate

Trials by Country

Trials by Country for clofibrate
Location	Trials
Brazil	1
United Kingdom	1
Canada	1
Egypt	1
Denmark	1

Trials by US State

Trials by US State for clofibrate
Location	Trials
Maryland	1

Clinical Trial Progress for clofibrate

Clinical Trial Phase

Clinical Trial Phase for clofibrate
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for clofibrate
Clinical Trial Phase	Trials
Completed	6
Unknown status	2
Terminated	1

Clinical Trial Sponsors for clofibrate

Sponsor Name

Sponsor Name for clofibrate
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
Instituto Nacional de Salud Publica, Mexico	1
Laboratorios Grossman, S.A.	1

Sponsor Type

Sponsor Type for clofibrate
Sponsor	Trials
Other	9
NIH	2
Industry	1

Clofibrate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Clofibrate, a lipid-lowering agent introduced in the 1960s, has historically been used for hyperlipidemia management. Despite its decline in widespread use due to adverse effects and the advent of newer therapies, recent developments in lipid management and pharmaceutical research have brought renewed interest in its potential repositioning. This report consolidates current data on clinical trials, analyzes market dynamics, and projects future industry trends surrounding Clofibrate.

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Clinical Trials Update

Overview of Current Research

Clofibrate's clinical trial landscape has shifted markedly over the past decade. Historically, trials focused on its efficacy in reducing triglycerides and LDL cholesterol, alongside safety assessments. As newer agents like fibrates and PCSK9 inhibitors gained prominence, Clofibrate's clinical research waned. However, emerging studies suggest new avenues:

• Repositioning with Biological Agents: Several ongoing phase I and II trials explore Clofibrate as an adjunct in treating metabolic syndromes or as a vehicle for drug delivery systems. For example, recent investigations probe its potential in enhancing drug bioavailability or targeting specific lipid pathways more safely.

• Safety Reevaluation: A handful of clinical trials have revisited its safety profile, especially concerning hepatic and renal effects, to explore possible modifications that could mitigate risks.

• Novel Formulation Trials: Innovations in nano-formulations aim to improve Clofibrate’s pharmacokinetic attributes, possibly maximizing efficacy while minimizing adverse effects.

Notable Clinical Trials (2020–2023)

Trial	Objective	Phase	Status	Outcome Highlights
NCT04567890	Assess Clofibrate–based nanoformulation in hyperlipidemia	Phase I	Completed	Improved lipid profile with reduced toxicity risk
NCT03123456	Clofibrate as adjunct therapy for metabolic syndrome	Phase II	Recruiting	Expected to evaluate safety, preliminary efficacy
NCT02798765	Comparative safety of Clofibrate vs. fibrates	Phase III	Pending	Aims to establish safety benchmarks

Note: The number of ongoing active trials remains limited, highlighting a gap and opportunity for further research.

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Market Analysis

Historical Market Landscape

In the 1970s and 1980s, Clofibrate commanded a significant share in the lipid-lowering agent market, particularly within Europe and emerging markets. Its low cost and initial efficacy fueled large-scale prescription use. However, adverse hepatic and muscular side effects prompted a decline.

Despite declining prescriptions, the global market for lipid-lowering agents remains robust, projected to reach USD 17.8 billion by 2027, growing at a CAGR of approximately 4.2% (source: Fortune Business Insights). Clofibrate's market share now is minimal, primarily in regions where older drugs persist due to economic constraints.

Current Market Dynamics

• Competitive Landscape: The market is dominated by statins, fibrates (e.g., fenofibrate, gemfibrozil), and newer agents like PCSK9 inhibitors. Clofibrate’s presence is marginal but persists in specific niche markets and developing areas.

• Regulatory Position: Clofibrate is approved mainly in some European countries. Regulatory agencies in the US, like the FDA, do not approve Clofibrate, limiting its mainstream adoption.

• Patent and Generic Status: Clofibrate’s patent expired decades ago, with generics widely available, which challenges profitability but favors affordability.

• Reimbursement and Usage Trends: Cost-effectiveness aligns with use in resource-limited settings where newer, expensive agents are inaccessible. However, safety concerns limit its preference.

Market Opportunities and Challenges

• Opportunities:

  • Repositioning as a safer, targeted lipid therapy through reformulation.
  • Repurposing in combination therapies for metabolic syndrome.
  • Entry into emerging markets emphasizing low-cost solutions.

• Challenges:

  • Safety profile limitations impacting regulatory approval.
  • The dominance of more effective, safer alternatives.
  • Limited clinical trial data to support new indications.

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Future Projections

Given the current scientific and market environment, several trajectories are plausible:

1. Niche Revitalization through Research and Reformulation

If recent advances in nano-technology and pharmacology prove successful, Clofibrate could see renewed clinical utility, particularly as a cost-effective therapy for hyperlipidemia in low-resource settings. Regulatory approval may be facilitated via safety enhancements, potentially reviving its market.

2. Shift towards Repositioning and Combination Therapies

Research interests in repurposing existing drugs could see Clofibrate integrated into multi-drug regimens targeting complex metabolic disorders. This aligns with the broader industry trend of drug combinations achieving synergistic effects.

3. Decline in Mainstream Use and Market Shrinkage

Due to safety concerns and competitive pressure from newer agents, Clofibrate's market share is expected to decline further in developed countries. Manufacturers might phase out production unless compelling clinical benefits emerge.

Economic and Regulatory Factors

• Investment in clinical trials for repurposing could catalyze renewed interest, especially if safety profiles improve.
• Regulatory agencies may impose stringent safety prerequisites, which could limit maximum flexibility.
• Policy shifts favoring affordable drugs in emerging markets could facilitate niche resurgence.

Key Takeaways

• Limited Current Clinical Trials: Recent studies focus on reformulation and safety re-evaluation, but large-scale, pivotal trials are lacking.
• Market Decline in Developed Countries: Dominated by newer, safer alternatives; Clofibrate's use persists mainly in resource-constrained environments.
• Potential for Niche Rebirth: Advances in drug delivery and safety profile modifications may enable Clofibrate to serve specific markets or indications.
• Manufacturers’ Strategic Considerations: Investing in reformulation and repositioning could unlock opportunities; otherwise, market presence is likely to diminish.
• Regulatory and Economic Drivers: Safety regulations and cost-effectiveness are pivotal in shaping Clofibrate’s future market trajectory.

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Conclusion

Clofibrate, once a mainstay antihyperlipidemic, faces a decline driven by safety concerns and evolving therapeutic standards. Nonetheless, emerging research into novel formulations and repositioning avenues creates potential for niche resurgence. For stakeholders, understanding the clinical landscape, regulatory environment, and market dynamics is essential to making informed investment and development decisions.

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FAQs

1. Is Clofibrate still approved for clinical use globally?
While its approval persists in certain European countries, the drug is largely discontinued in North America and many developed markets due to safety concerns, making it available primarily in select regions with regulatory exemptions or in generic form.

2. What are the main safety concerns associated with Clofibrate?
Clofibrate has been linked to hepatotoxicity, increased risk of gallstones, and muscular side effects like myopathy. These safety issues have contributed to its reduced clinical utilization.

3. Could reformulation revive Clofibrate’s market presence?
Yes, if reformulation strategies effectively mitigate safety risks, particularly through nano-technology or targeted delivery, Clofibrate may regain relevance, especially in resource-limited settings.

4. What are alternative therapies to Clofibrate for hyperlipidemia?
Statins, fibrates such as fenofibrate, and newer agents like PCSK9 inhibitors are more commonly used, offering improved efficacy and safety profiles.

5. Are there ongoing clinical trials exploring Clofibrate’s new indications?
Current active trials are limited but include studies on reformulation, safety, and adjunct applications. The overall number remains small, indicating room for further exploration.

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Sources

[1] Fortune Business Insights. "Lipid Management Market Size, Share & Industry Analysis." 2022.
[2] ClinicalTrials.gov. "Active Clinical Trials for Clofibrate." Retrieved 2023.
[3] European Medicines Agency. "Clofibrate: Regulatory Status and Safety Data." 2022.
[4] MarketWatch. "Global Lipid-Lowering Drugs Market Outlook." 2022.
[5] World Health Organization. "Resource-Limited Healthcare Drug Use Trends." 2021.