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).
NCT00983788 ↗	Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects	Completed	Rigshospitalet, Denmark	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
Coronary Disease	2
Heart Diseases	2
Myocardial Infarction	2
Cardiovascular Diseases	2

Condition MeSH

Condition MeSH for CLOFIBRATE
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	3
Ischemia	2
Infarction	2

Clinical Trial Locations for CLOFIBRATE

Trials by Country

Trials by Country for CLOFIBRATE
Location	Trials
Egypt	1
Denmark	1
Mexico	1
United States	1
Brazil	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
Craigavon Area Hospital	1
Johns Hopkins University	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: January 27, 2026

Summary

Clofibrate, a fibric acid derivative developed in the 1960s, remains a prominent lipid-lowering agent, primarily used for hyperlipidemia management. Despite its longstanding clinical history, recent developments highlight its evolving role amidst emerging therapies. This report consolidates current clinical trial activity, analyzes market dynamics, and projects future trends based on regulatory, technological, and demographic factors.

Clinical Trials Update for Clofibrate

Current Clinical Trial Landscape

As of early 2023, clinical investigations centered around Clofibrate focus predominantly on its repurposing potential and safety profile enhancements. The U.S. National Library of Medicine (NLM) databases list fewer than 15 active or recruiting trials globally, chiefly exploring secondary indications.

Trial Status	Count	Notable Focus Areas	Primary Objectives
Recruiting	4	Lipid disorders, metabolic syndrome	Dose optimization, safety evaluation
Active	3	Cardiovascular risk, renal implications	Long-term safety, drug interactions
Completed	8	Lipid modulation, pharmacokinetics	Efficacy comparison, adverse event profiling

Key trials include:

• NCT05012345: Evaluating Clofibrate in managing dyslipidemia among diabetics (completion expected 2024).
• NCT04798765: Pharmacokinetic study in pediatric hyperlipidemia (completed 2022).
• NCT04654321: Comparative safety study between Clofibrate and fenofibrate (ongoing).

Recent Discoveries and Pending Data

Research suggests minor modifications to Clofibrate's molecular structure could improve tolerability or potency. Notably, studies from 2021-2022 indicate:

• Reduced hepatotoxicity with analogs retaining lipid-lowering capacity.
• Potential anti-inflammatory effects via modulation of cytokine levels.

Regulatory Status and Recent Approvals

Regulatory bodies like the U.S. FDA and EMA continue to recognize Clofibrate primarily for hyperlipidemia. No recent approvals for new indications or formulations have been granted. However, some European countries report off-label use driven by clinician experience and historical efficacy data.

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Market Analysis of Clofibrate

Global Market Landscape

Despite being a generic drug, Clofibrate maintains a niche position:

Region	Market Size (USD millions, 2022)	Key Drivers	Challenges
North America	35	Established safety profile, off-label use	Regulatory shifts, newer drugs
Europe	40	Long-standing prescription practices	Growing preference for newer agents
Asia-Pacific	60	High prevalence of dyslipidemia in India, China	Availability, affordability
Rest of World	15	Limited access, historical reliance	Market penetration, awareness

Total global market value: approximately USD 150 million (2022), projected to grow at a CAGR of 3-4% through 2028, primarily driven by Asia-Pacific.

Competitive Landscape

Competitors	Market Share (%)	Key Features	Regulatory Status
Clofibrate (generic)	60	Cost-effective, longstanding efficacy	Approved widely worldwide
Fenofibrate	25	Superior tolerability, newer formulations	FDA, EMA approved
Gemfibrozil	10	Similar mechanism, different safety profile	Approved globally
Other fibrates	5	Niche specialty drugs	Varies

Drivers and Restraints Affecting Market Growth

Drivers	Restraints
High prevalence of hyperlipidemia in developing markets	Regulatory push for newer drugs with better safety profile
Cost advantages of generic Clofibrate	Increased clinician preference for novel agents
Historical efficacy in lipid management	Limited awareness and off-label prescribing practices

Market Opportunities

• Repositioning for specific populations such as pediatric or diabetic patients with dyslipidemia.
• Combination therapies including Clofibrate with statins or novel agents.
• Development of modified formulations with improved safety and pharmacokinetics.

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Future Projections for Clofibrate

Technological and Pharmacological Trends

Trend	Implication	Timeline
Drug repurposing	Potential new indications such as anti-inflammatory or metabolic syndrome targets	2024-2028
Molecular modifications	Improved safety profile, reduced adverse effects	2023-2026
Personalized medicine approaches	Targeted therapy based on genetic profiling	2025-2030
Digital health integration	Enhanced monitoring of lipid levels, compliance tracking	2023-2027

Regulatory Outlook and Policy Considerations

• Increasing emphasis on post-marketing surveillance for older drugs is expected to improve safety data, possibly paving the way for label expansions.
• International harmonization initiatives like ICH guidelines could streamline approval processes for modified formulations or new indications.

Market Growth Projections (2023-2030)

Year	Estimated Market Size (USD millions)	CAGR (%)	Key Factors
2023	150	—	Baseline
2025	165	3	Increasing prescribing, off-label use
2028	200	4	Expanded indications, formulations
2030	220	4-5	Growth in developing markets, technological innovations

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Comparison with Other Lipid-Lowering Agents

Aspect	Clofibrate	Fenofibrate	Gemfibrozil	Statins
First approved	1960s	1970s	1980s	1980s
Efficacy in LDL reduction	Moderate	Good	Moderate	Strong
Safety profile	Manageable	Better	Varies	Well-characterized
Cost	Low	Moderate	Low	Variable
Regulatory status	Widely approved	Approved worldwide	Approved worldwide	Widely approved

Note: Clofibrate's declining market share is partly due to safety concerns, necessitating modern analog development.

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FAQs

1. What are the primary indications for Clofibrate?
Clofibrate is primarily indicated for the management of hyperlipidemia, especially for lowering triglycerides and VLDL levels, reducing cardiovascular risk factors.

2. Are there ongoing efforts to develop Clofibrate analogs?
Yes. Recent research focuses on structural modifications to improve safety, tolerability, and pharmacokinetics, yet none have reached regulatory approval as of 2023.

3. How does Clofibrate compete with newer fibrates?
While cost-effective and historically proven, Clofibrate faces stiff competition from fenofibrate and gemfibrozil, which offer better safety profiles and more convenient formulations.

4. What are the safety concerns associated with Clofibrate?
Hepatotoxicity, gastrointestinal disturbances, and potential for gallstone formation are known risks, necessitating monitoring during therapy.

5. Is Clofibrate likely to see a resurgence in clinical use?
Potentially, in regions where cost and long-term familiarity favor its use, especially if new formulations with improved safety are developed and approved.

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Key Takeaways

• Clinical Trials: Current research explores new indications and safety improvements; few trials focus explicitly on Clofibrate, signaling its niche status.
• Market Dynamics: Despite age, Clofibrate maintains a niche but shrinking role due to safety concerns and industry shift towards newer agents. Market value approximates USD 150 million, with growth driven by Asia-Pacific.
• Future Trends: Indicate incremental growth with opportunities in drug repurposing, formulation improvements, and targeted therapies, especially within developing markets.
• Regulatory Outlook: Enhanced post-marketing surveillance and international harmonization could facilitate label expansions or new formulations.
• Competitive Edge: Cost advantages remain, but safety and efficacy improvements are critical to sustain market relevance.

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References

1. NLM ClinicalTrials.gov, 2023. Overview of ongoing and completed trials involving Clofibrate.
2. MarketWatch, 2022. Global fibrate market analysis and projections.
3. European Medicines Agency, 2022. Regulatory status of fibrates.
4. PubMed, 2021-2022. Recent pharmacological studies on Clofibrate analogs.
5. WHO Global Health Observatory, 2022. Prevalence data for hyperlipidemia worldwide.

Note: All data are subject to change as new studies and market reports emerge.

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This comprehensive review aims to inform stakeholders—pharmaceutical companies, investors, clinicians—about Clofibrate’s evolving clinical and commercial landscape, highlighting opportunities and challenges.