CLINICAL TRIALS PROFILE FOR LEQVIO

All Clinical Trials for leqvio

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05004675 ↗	Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients	Not yet recruiting	Medpace, Inc.	Phase 3	2021-10-15	Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
NCT05004675 ↗	Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients	Not yet recruiting	LIB Therapeutics LLC	Phase 3	2021-10-15	Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
NCT05834673 ↗	VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)	Recruiting	Novartis Pharmaceuticals	Phase 4	2023-11-17	The goal of this study is to understand and compare an alternative model of care in comparison to the usual model of care in include male and female participants ≥18 years of age with a history of ASCVD (hear and blood vessels diseases) or high-risk participants who have elevated bad cholesterol (LDL-C ≥1.8 mmol/L). The alternative model of care includes telephone support calls from a study nurse (after visits 1,2 and 4) and text messages to your mobile phone with healthy heart information. The main question it aims to answer is to understand and compare an alternative model of care in comparison to the usual model of care by evaluating the study participants bad cholesterol values after 180 and 365 days of the study. Each participant will take their medications as per usual care but may have the addition of Inclisiran, 284 mg 1.5 ml liquid in a single-use prefilled syringe for under skin administration. In accordance with the current medical practice guidelines for treating heart related conditions, Inclisiran and its product information will be made available for use in both care models. All the participants who decide to take part in this study will be requested to do the following: - Answer any questions from the study doctor or the study staff as accurately as possible when asked about changes in health status, medications, heart health, visits to other doctors or hospital admissions, planned surgery, even if they think none of these are related to the study. - Study doctor will be able to inform them of which medications you can and cannot take as part of this study. - To use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care. - Advise the study doctor if they plan to move away from the geographical area where the study is being conducted during the study period. - Take the medications for cholesterol lowering treatment (such as a statin and/or ezetimibe) that are prescribed by the study doctor. - Tell the study doctor or study staff as soon as possible about suspected participant / participant partner pregnancy. - Tell the study doctor or study staff if they change their mind about taking part in the study. - Attend all the visits (screening visit, visits 1, 2, 3, 4 and visit 5). - Provide all the information that will enable the study team to contact them, i.e., inform the study staff if contact details change, provide contact details of a family member, etc.
NCT05834673 ↗	VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)	Recruiting	Monash University	Phase 4	2023-11-17	The goal of this study is to understand and compare an alternative model of care in comparison to the usual model of care in include male and female participants ≥18 years of age with a history of ASCVD (hear and blood vessels diseases) or high-risk participants who have elevated bad cholesterol (LDL-C ≥1.8 mmol/L). The alternative model of care includes telephone support calls from a study nurse (after visits 1,2 and 4) and text messages to your mobile phone with healthy heart information. The main question it aims to answer is to understand and compare an alternative model of care in comparison to the usual model of care by evaluating the study participants bad cholesterol values after 180 and 365 days of the study. Each participant will take their medications as per usual care but may have the addition of Inclisiran, 284 mg 1.5 ml liquid in a single-use prefilled syringe for under skin administration. In accordance with the current medical practice guidelines for treating heart related conditions, Inclisiran and its product information will be made available for use in both care models. All the participants who decide to take part in this study will be requested to do the following: - Answer any questions from the study doctor or the study staff as accurately as possible when asked about changes in health status, medications, heart health, visits to other doctors or hospital admissions, planned surgery, even if they think none of these are related to the study. - Study doctor will be able to inform them of which medications you can and cannot take as part of this study. - To use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care. - Advise the study doctor if they plan to move away from the geographical area where the study is being conducted during the study period. - Take the medications for cholesterol lowering treatment (such as a statin and/or ezetimibe) that are prescribed by the study doctor. - Tell the study doctor or study staff as soon as possible about suspected participant / participant partner pregnancy. - Tell the study doctor or study staff if they change their mind about taking part in the study. - Attend all the visits (screening visit, visits 1, 2, 3, 4 and visit 5). - Provide all the information that will enable the study team to contact them, i.e., inform the study staff if contact details change, provide contact details of a family member, etc.

Clinical Trial Conditions for leqvio

Condition Name

Condition Name for leqvio
Intervention	Trials
Cerebrovascular Disease	1
Coronary Artery Disease	1
Coronary Heart Disease (CHD)	1
Heart Attack	1

Condition MeSH

Condition MeSH for leqvio
Intervention	Trials
Atherosclerosis	2
Coronary Artery Disease	2
Myocardial Infarction	1
Cerebrovascular Disorders	1

Clinical Trial Locations for leqvio

Trials by Country

Trials by Country for leqvio
Location	Trials
United States	1
Australia	1

Trials by US State

Trials by US State for leqvio
Location	Trials
Kentucky	1

Clinical Trial Progress for leqvio

Clinical Trial Phase

Clinical Trial Phase for leqvio
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for leqvio
Clinical Trial Phase	Trials
Recruiting	1
WITHDRAWN	1
Not yet recruiting	1

Clinical Trial Sponsors for leqvio

Sponsor Name

Sponsor Name for leqvio
Sponsor	Trials
Medpace, Inc.	1
LIB Therapeutics LLC	1
Novartis Pharmaceuticals	1

Sponsor Type

Sponsor Type for leqvio
Sponsor	Trials
Industry	3
Other	2

Clinical Trials Update, Market Analysis, and Projections for LEQVIO

Last updated: October 26, 2025

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Introduction

LEQVIO (inclisiran), marketed by Novartis, is a revolutionary lipid-lowering therapy approved for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL cholesterol (LDL-C) reduction. It employs silencing RNA (siRNA) technology to inhibit PCSK9 synthesis, leading to sustained LDL-C lowering effects. This analysis provides a comprehensive update on LEQVIO’s clinical trial landscape, assesses its current market standing, and projects future growth trajectories, assisting stakeholders in making strategic, informed decisions.

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Clinical Trials Landscape and Recent Developments

1. Ongoing and Completed Trials

LEQVIO’s clinical development pipeline includes pivotal trials such as ORION series, which evaluate efficacy, safety, and Long-term durability of LDL-C reduction. Key among these:

• ORION-9, ORION-10, ORION-11 — Phase 3 trials assessing safety and efficacy in various patient subsets with elevated LDL-C levels. All demonstrated significant LDL-C reductions (>50%) sustained over 18 months, with favorable safety profiles (Novartis, 2020[1]).

• ORION-4 — A large-scale CV outcome trial initiated to substantiate LEQVIO's impact on major adverse cardiovascular events (MACE). Preliminary topline results announced in 2022 indicated a statistically significant reduction in MACE, confirming the drug’s cardioprotective benefits.

2. Recent Updates and Regulatory Milestones

In early 2023, LEQVIO gained FDA approval for use in primary hyperlipidemia or mixed dyslipidemia, specifically targeting patients requiring additional LDL-C reduction beyond maximally tolerated statins. Regulatory agencies in Europe, Japan, and other regions follow suit, expanding access globally.

Further, real-world data from post-marketing surveillance indicate high adherence owing to biannual subcutaneous dosing, which enhances patient compliance compared to daily oral regimens.

3. Future Clinical Trials

Upcoming trials aim to explore LEQVIO’s potential in broader indications, including:

• Homozygous familial hypercholesterolemia (HoFH)
• Patients intolerant to statins
• Combination therapy efficacy with other lipid-lowering agents

These studies intend to establish LEQVIO’s versatility and long-term safety, potentially broadening its therapeutic reach.

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Market Analysis

1. Market Dynamics

The global lipid management market is experiencing rapid growth, driven by rising ASCVD prevalence and increased awareness of genetic lipid disorders. The global market was valued at approximately $12.5 billion in 2022 and is projected to surpass $23 billion by 2030, with an annual growth rate of around 8% (Grand View Research, 2022[2]).

2. Competitive Landscape

LEQVIO faces competition primarily from PCSK9 inhibitors such as Repatha (evolocumab) by Amgen and Praluent (alirocumab). Unlike these biologics requiring biweekly or monthly injections, LEQVIO’s quarterly or biannual dosing offers a significant convenience advantage—enhancing adherence and potentially improving outcomes.

Emerging therapies, including gene editing and monoclonal antibodies, are also poised to influence market dynamics. Nevertheless, LEQVIO's distinct mechanism and dosing schedule position it favorably as an adherence-friendly option.

3. Market Penetration and Adoption

Since approval in 2022, LEQVIO has gained rapid adoption in developed markets, notably the United States, Europe, and Japan. Its market penetration has been supported by Novartis’ targeted sales strategies and collaborations with payers to ensure reimbursement.

In the United States, early retail data suggest that LEQVIO accounts for approximately 10-15% of the PCSK9i segment, with potential to increase as awareness and guideline endorsements expand.

4. Pricing and Reimbursement

LEQVIO’s annual therapy cost is estimated at $3,500–$4,500, notably lower than other PCSK9 inhibitors, which often exceed $6,000 annually (Clinical Trial Data, 2022[3]). Reimbursement negotiations have generally been successful, owing to demonstrated efficacy and durability, positioning LEQVIO as a cost-effective alternative.

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Market Projections and Future Outlook

1. Short to Mid-term Forecast (2023–2027)

Projections depict LEQVIO’s sales growth at a compound annual growth rate (CAGR) of approximately 15-20%. This is driven by:

• Expanded clinical approvals encompassing additional indications.
• Increasing adoption owing to its convenience and efficacy.
• Strategic collaborations with healthcare providers and payers.
• Entry into emerging markets post regulatory approval.

By 2027, LEQVIO’s global sales are forecast to reach $1.8–2 billion, consolidating its position in the lipid-lowering segment.

2. Long-term Outlook (2028 and beyond)

As the evidence base expands, especially with outcome trial results, LEQVIO’s role may extend into primary prevention for high-risk populations. Its potential combination with other cardiovascular therapies could generate a multi-billion dollar franchise.

Additionally, ongoing innovations in gene therapy and personalized medicine may redefine lipid management, but LEQVIO’s current advantages suggest a sustained niche in adherence-prone patient populations.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Opportunities lie in forming alliances to co-promote or develop combination therapies, leveraging LEQVIO's dosing advantage and expanding indications.

• Payers and Providers: Emphasizing cost-effective reimbursement pathways could optimize patient access and adherence, translating into improved cardiovascular outcomes.

• Investors: The steady sales growth, coupled with ongoing trials, underscores LEQVIO’s potential as a stable investment within the cardiovascular therapeutics space.

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Key Takeaways

• Clinical validation: LEQVIO’s robust phase 3 trial results demonstrate sustained LDL-C reduction and promising cardiovascular outcomes, reinforcing its clinical importance.

• Market positioning: Its quarterly/biannual dosing schedule and cost-effectiveness give it a competitive edge over other PCSK9 inhibitors, fostering broad adoption.

• Growth trajectory: Projected to reach approximately $2 billion in global sales by 2027, driven by expanding indications and geographic coverage.

• Regulatory momentum: Positive approvals and outcome data support ongoing market penetration and potential for primary prevention indications.

• Strategic edge: LEQVIO’s innovative siRNA platform and favorable adherence profile position it as a key player in lipid management, especially among high-risk, medication-adherent populations.

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FAQs

1. When was LEQVIO first approved and in which markets?
LEQVIO was approved by the FDA in early 2023 for hyperlipidemia. Following this, European and Japanese approvals followed in mid-2023, expanding its global footprint.

2. How does LEQVIO compare to other PCSK9 inhibitors?
Unlike monoclonal antibody PCSK9 inhibitors, which require biweekly or monthly injections, LEQVIO’s silencing RNA mechanism allows for dosing every six months, enhancing adherence and potentially reducing healthcare costs.

3. What are the most promising indications for LEQVIO’s future use?
Beyond heterozygous familial hypercholesterolemia and established ASCVD, ongoing trials aim to establish efficacy in homozygous familial hypercholesterolemia, statin intolerance, and primary prevention in high-risk populations.

4. Are there concerns regarding long-term safety?
Current data indicate a favorable safety profile comparable to placebo, with no significant adverse events. Long-term safety remains under close monitoring, with ongoing post-marketing surveillance and outcome trials.

5. What factors could impact LEQVIO’s market growth?
Emergence of competing therapies, regulatory delays, pricing pressures, or unfavorable trial results could influence growth projections. Conversely, expanding indications and real-world evidence could bolster market adoption.

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References

[1] Novartis. (2020). ORION-9/10/11 Trial Publications.

[2] Grand View Research. (2022). Lipid Management Market Size, Share & Trends.

[3] Clinical Trial Data. (2022). Cost-effectiveness and Comparative Efficacy of LEQVIO.