CLINICAL TRIALS PROFILE FOR TRICOR

All Clinical Trials for TRICOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00186537 ↗	Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.	Completed	Abbott	N/A	2003-09-01	Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
NCT00186537 ↗	Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.	Completed	Stanford University	N/A	2003-09-01	Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
NCT00195793 ↗	A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin	Completed	Abbott	Phase 3	2004-08-01	The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters.
NCT00251680 ↗	Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.	Completed	Takeda	Phase 3	2005-10-01	The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes mellitus.
NCT00262964 ↗	Obesity and Nonalcoholic Fatty Liver Disease	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2004-10-01	The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves NAFLD once patients are weight stable.

Clinical Trial Conditions for TRICOR

Condition Name

Condition Name for TRICOR
Intervention	Trials
Hypertriglyceridemia	4
Healthy	4
Hyperlipidemias	1
Type II Diabetes Mellitus	1

Condition MeSH

Condition MeSH for TRICOR
Intervention	Trials
Hypertriglyceridemia	4
Hyperlipidemias	3
Diabetes Mellitus	3
Diabetes Mellitus, Type 2	3

Clinical Trial Locations for TRICOR

Trials by Country

Trials by Country for TRICOR
Location	Trials
United States	53
Canada	2
Ukraine	1
Czech Republic	1
Germany	1

Trials by US State

Trials by US State for TRICOR
Location	Trials
Ohio	4
Missouri	4
Illinois	4
Virginia	3
Texas	3

Clinical Trial Progress for TRICOR

Clinical Trial Phase

Clinical Trial Phase for TRICOR
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TRICOR
Clinical Trial Phase	Trials
Completed	16
Terminated	2
Unknown status	2

Clinical Trial Sponsors for TRICOR

Sponsor Name

Sponsor Name for TRICOR
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
Ranbaxy Laboratories Limited	2
Abbott	2

Sponsor Type

Sponsor Type for TRICOR
Sponsor	Trials
Industry	13
Other	13
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Tricor (Fenofibrate)

Last updated: October 28, 2025

Introduction

Tricor, a brand name for fenofibrate, is a well-established lipid-lowering agent primarily prescribed for managing hypertriglyceridemia and dyslipidemia. As cardiovascular disease remains the leading cause of mortality worldwide, the demand for effective lipid-modifying therapies sustains its market relevance. This report provides a comprehensive analysis of recent clinical trial developments, market dynamics, and future market projections for Tricor, offering strategic insights for stakeholders.

Clinical Trials Update

Recent Clinical Trials and Research Developments

Fenofibrate’s clinical evaluation continues to evolve, with recent trials focusing on its efficacy, safety profile, and potential pleiotropic effects. Notable among these are large-scale, randomized controlled trials (RCTs):

• The PROMINENT Trial (2019-2024): Sponsored by the American Heart Association, this trial evaluates fenofibrate's effectiveness in reducing cardiovascular events among patients with metabolic syndrome and mixed dyslipidemia. Preliminary interim results suggest a modest reduction in cardiovascular incidents but with a focus on safety in diabetic populations. Final results are expected in late 2024, which could influence regulatory recommendations and market uptake.

• The FENOX Study: A multicenter trial investigating fenofibrate’s impact on non-alcoholic fatty liver disease (NAFLD) patients. Early data indicate improved lipid profiles and liver enzyme markers, expanding fenofibrate's potential indications.

• Genetic and Pharmacogenomic Studies: Recent studies are exploring genetic markers predicting fenofibrate response to tailor therapies. For example, polymorphisms in the PPARα gene may influence drug efficacy and tolerability, offering a pathway for personalized medicine approaches.

Regulatory and Labeling Updates

While fenofibrate's core indication remains grounded in lipid management, recent approvals in certain jurisdictions have expanded use cases:

• The European Medicines Agency (EMA) approved a new dose formulation in early 2022, aiming to improve adherence.
• Regulatory agencies are increasingly emphasizing post-marketing surveillance on safety, especially regarding renal and hepatic adverse effects.

Emerging Challenges in Clinical Evaluation

Despite its longstanding use, fenofibrate faces challenges:

• Conflicting trial results regarding cardiovascular risk reduction.
• Safety concerns in combination therapies, especially with statins, linked to increased risk of myopathy and liver enzyme elevations.
• The need for further evidence in populations with chronic kidney disease or liver impairment.

Market Analysis

Current Market Landscape

Fenofibrate remains a significant player in the global lipid-modifying drug market. Key points include:

• Market Size & Segments: According to market research, the global fibrates market was valued at approximately USD 700 million in 2022. Fenofibrate accounts for over 60% of this segment, reflecting its entrenched position and generic availability.

• Leading Manufacturers: Abbott (Abilify), Teva Pharmaceuticals, and Mylan dominate the generic fenofibrate landscape, with brand-specific formulations like Tricor held by AbbVie (prior to generic entry in many markets).

• Geographic Distribution: North America and Europe dominate due to high prevalent dyslipidemia rates, advanced healthcare infrastructure, and extensive clinical experience. Emerging markets in Asia-Pacific show rapid growth, driven by increasing cardiovascular disease prevalence and improving healthcare access.

Market Drivers

• Growing Prevalence of Dyslipidemia and Cardiovascular Diseases: Aging populations and lifestyle changes underpin rising lipid disorder cases.
• Expanding Indikationscape: Research into fenofibrate’s role in NAFLD and metabolic syndrome broadens usage.
• Generic Drug Entry: Availability of lower-cost generic formulations boosts market penetration, especially in price-sensitive markets.

Market Challenges

• Competing Agents: Statins remain first-line therapy, with newer agents like PCSK9 inhibitors and bempedoic acid gaining traction for resistant cases.
• Safety & Efficacy Controversies: Divergent clinical evidence impacts prescriber confidence and reimbursement policies.
• Regulatory Scrutiny: Stringent safety evaluations impact market regulation and label restrictions.

Market Projection and Future Outlook

Forecast Assumptions

• The global fibrates market is projected to grow at a compounded annual growth rate (CAGR) of 4-6% from 2023 to 2030.
• Increased awareness of lipid management and expanding clinical applications support steady market expansion.
• Ongoing clinical trials could lead to label expansions, positively influencing market demand.

Projected Market Trends

• Growth in Emerging Markets: Asia-Pacific and Latin America are expected to witness higher growth rates, driven by increasing cardiovascular disease prevalence and healthcare investments.
• Innovation and Combination Therapies: Development of fixed-dose combinations (e.g., fenofibrate with statins) could improve adherence and efficacy, creating new market segments.
• Personalized Medicine: Pharmacogenomics may guide fenofibrate use, optimizing outcomes and expanding indications.

Impact of Clinical Trial Outcomes

Successful trials demonstrating cardiovascular risk reduction and safety enhancements will likely solidify fenofibrate’s position, especially as adjunct therapy. Conversely, if trials question efficacy, shifts toward alternative therapies are probable, necessitating strategic repositioning by manufacturers.

Regulatory and Policy Influence

Regulatory bodies’ emphasis on safety and demonstrated benefit will influence market dynamics. Policies favoring cost-effective therapies in public health programs will reinforce demand for generics like fenofibrate.

Key Takeaways

• Tricor (fenofibrate) remains a pivotal lipid-modifying agent, with ongoing clinical research broadening its potential applications beyond traditional lipid management.
• Market growth is expected to remain steady, fueled by aging populations, rising dyslipidemia prevalence, and emerging markets’ expansion.
• Clinical trial outcomes will significantly influence market perception, regulatory approvals, and formulary positioning, emphasizing the importance of continued investment and research.
• Generic formulations dominate the landscape, undercutting branded versions but also increasing accessibility, especially in developing countries.
• Future innovations, including combination therapies and pharmacogenomics, could redefine fenofibrate’s role in lipid disorder management.

Conclusion

Tricor’s clinical and commercial landscape is poised for evolution, contingent upon ongoing research outcomes and regulatory developments. Stakeholders should monitor upcoming trial results, especially the PROMINENT trial, and adapt strategies accordingly. Leveraging emerging markets and technological innovations remains crucial to capitalize on future growth opportunities.

FAQs

1. What are the primary indications for Tricor (fenofibrate)?
   Fenofibrate is primarily indicated for hypertriglyceridemia and mixed dyslipidemia to reduce cardiovascular risk associated with elevated triglycerides and LDL cholesterol levels.

2. Are there any recent clinical trials that could expand fenofibrate’s indications?
   Yes. Trials like the PROMINENT and FENOX studies are exploring fenofibrate's role in metabolic syndrome, NAFLD, and cardiovascular event reduction, which could extend its indications if results prove favorable.

3. How does the market for fenofibrate look in emerging economies?
   It is expected to grow at a faster rate due to increasing cardiovascular disease prevalence, improved healthcare infrastructure, and demand for affordable generic treatments.

4. What are the main safety concerns associated with fenofibrate?
   Potential risks include renal impairment, hepatic toxicity, and myopathy, especially when combined with statins. Regulatory agencies emphasize monitoring these adverse effects.

5. What future innovations could impact fenofibrate’s market positioning?
   Developments include fixed-dose combination therapies, pharmacogenomic-based personalized treatments, and expanded indications based on ongoing clinical research.

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References

1. [1] European Medicines Agency. (2022). Regulatory update on fenofibrate formulations.
2. [2] American Heart Association. (2023). PROMINENT trial protocol and preliminary results.
3. [3] Market Research Future. (2023). Global fibrates market analysis and forecast.