CLINICAL TRIALS PROFILE FOR LIPIDIL

All Clinical Trials for LIPIDIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00458055 ↗	High-Density Lipoprotein (HDL) Treatment Study	Completed	McGill University Health Center	N/A	2006-11-01	A low level of plasma high-density lipoprotein (HDL) cholesterol, "the good cholesterol", is the most common lipid abnormality observed in patients with a premature atherosclerotic cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to be metabolized or excreted, a process known as reverse cholesterol transport. Epidemiological studies have shown an inverse correlation between plasma levels of HDL cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary fat intake - all patients are encouraged to follow these lifestyle modifications; 2) medications which can raise HDL cholesterol. Currently used medications to treat lipid disorders can increase, in some extent, HDL cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and statins. However there is no data on the effect of these medications on severe cases of HDL deficiency. This project aims to determine whether currently available medications, used in standard medical practice for the treatment of lipoprotein disorders, can substantially increase HDL cholesterol in severe cases of HDL deficiencies.
NCT00458055 ↗	High-Density Lipoprotein (HDL) Treatment Study	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A	2006-11-01	A low level of plasma high-density lipoprotein (HDL) cholesterol, "the good cholesterol", is the most common lipid abnormality observed in patients with a premature atherosclerotic cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to be metabolized or excreted, a process known as reverse cholesterol transport. Epidemiological studies have shown an inverse correlation between plasma levels of HDL cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary fat intake - all patients are encouraged to follow these lifestyle modifications; 2) medications which can raise HDL cholesterol. Currently used medications to treat lipid disorders can increase, in some extent, HDL cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and statins. However there is no data on the effect of these medications on severe cases of HDL deficiency. This project aims to determine whether currently available medications, used in standard medical practice for the treatment of lipoprotein disorders, can substantially increase HDL cholesterol in severe cases of HDL deficiencies.
NCT00809068 ↗	High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone	Completed	Keogh Institute for Medical Research	Phase 4	2005-08-01	Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%. This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.

Clinical Trial Conditions for LIPIDIL

Condition Name

Condition Name for LIPIDIL
Intervention	Trials
Coronary Arteriosclerosis	1
Dyslipidemia	1
Genetic Diseases, Inborn	1

Condition MeSH

Condition MeSH for LIPIDIL
Intervention	Trials
Hypoalphalipoproteinemias	1
Genetic Diseases, Inborn	1
Coronary Artery Disease	1

Clinical Trial Locations for LIPIDIL

Trials by Country

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Trials by Country for LIPIDIL
Location	Trials
Korea, Republic of	2
Australia	1
Canada	1

Clinical Trial Progress for LIPIDIL

Clinical Trial Phase

Clinical Trial Phase for LIPIDIL
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	3
N/A	1

Clinical Trial Status

Clinical Trial Status for LIPIDIL
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for LIPIDIL

Sponsor Name

Sponsor Name for LIPIDIL
Sponsor	Trials
Chong Kun Dang Pharmaceutical	1
McGill University Health Center	1
McGill University Health Centre/Research Institute of the McGill University Health Centre	1

Sponsor Type

Sponsor Type for LIPIDIL
Sponsor	Trials
Industry	4
Other	3

LIPIDIL and Related Therapies: Clinical Trials, Market Analysis, and Projections

Introduction to LIPIDIL and Related Therapies

LIPIDIL, though not explicitly mentioned in the sources, can be contextualized within the broader landscape of lipid-lowering therapies and the use of lipid nanoparticles (LNPs) in drug delivery. This article will delve into recent clinical trials, market analysis, and projections for therapies that target lipid-related cardiovascular diseases, highlighting key developments and trends.

Clinical Trials Update

Lepodisiran: A Promising Therapy for Lipoprotein(a) Reduction

A significant development in the field of lipid-lowering therapies is the experimental therapy lepodisiran. In a phase 1 trial presented at the American Heart Association’s Scientific Sessions 2023, lepodisiran demonstrated remarkable efficacy in reducing lipoprotein(a) [Lp(a)] levels. Participants who received the highest dose of lepodisiran saw their Lp(a) levels reduced by up to 96% within two weeks, with these levels maintained for nearly a year[1].

This therapy, developed by Eli Lilly and Company, uses small interfering RNA (siRNA) to block the messenger RNA needed to manufacture a key component of Lp(a) in the liver. The trial showed no significant safety issues, with only mild injection site reactions reported. This approach offers hope for the 20% of the global population with elevated Lp(a) levels, a key risk factor for heart disease.

Obicetrapib: Phase 3 Trials for LDL-C Reduction

NewAmsterdam Pharma's obicetrapib has also shown promising results in its phase 3 BROADWAY clinical trial. Obicetrapib significantly reduced LDL-C levels by 33% compared to placebo at day 84, with a 21% reduction in major adverse cardiovascular events (MACE) observed over one year. The drug was well-tolerated, with safety results comparable to placebo[3].

VERVE-102: Gene Editing for PCSK9

Verve Therapeutics is advancing its PCSK9 program with the initiation of the Heart-2 clinical trial expected in the second quarter of 2024. VERVE-102 is a gene editing medicine designed to permanently turn off the PCSK9 gene, which is involved in cholesterol regulation. This therapy uses lipid nanoparticles (LNPs) that have been well-tolerated in previous clinical trials[4].

Market Analysis and Projections

Lipid Nanoparticles Market

The lipid nanoparticles (LNPs) market is experiencing significant growth driven by advancements in mRNA therapies and the increasing burden of chronic diseases such as heart disease and cancer.

• Market Size and Growth: The global LNPs market is projected to grow from USD 1.002 billion in 2024 to USD 3.694 billion by 2034, at a CAGR of 13.93%[2].
• Regional Market: North America is the largest market, while the Asia Pacific region is expected to grow at the highest CAGR during the forecast period[2][5].

Key Drivers

• Chronic Diseases: The rising incidence of chronic diseases like heart disease and cancer is driving the demand for effective therapeutic measures, including those delivered via LNPs[5].
• Technological Advancements: Increasing investment in gene therapy and nanotechnology is fueling the development of novel therapies. For instance, government initiatives like the NIH's annual investment of USD 200 million in nanotechnology research are significant drivers[5].
• Targeted Drug Delivery: LNPs offer several benefits, including targeted drug delivery, improved solubility, and efficacy, which are crucial for treating various therapeutic areas[5].

Market Challenges

Despite the promising growth, the LNPs market faces challenges such as:

• High Formulation Costs: The development of LNPs is costly, which can be a barrier to entry for some companies.
• Limited Loading Capacity: LNPs have limited capacity to load therapeutic agents, which can affect their efficacy.
• Regulatory Compliance: Stringent regulatory requirements can slow down the approval process for new therapies[5].

Key Takeaways

• Clinical Trials: Lepodisiran and obicetrapib have shown significant efficacy in reducing Lp(a) and LDL-C levels, respectively, with promising safety profiles.
• Market Growth: The LNPs market is expected to grow substantially, driven by the need for effective treatments for chronic diseases and advancements in gene therapy and nanotechnology.
• Regional Focus: North America is the largest market, but the Asia Pacific region is expected to grow at the highest rate.
• Challenges: High formulation costs, limited loading capacity, and stringent regulatory compliance are key challenges facing the LNPs market.

FAQs

What is the current status of lepodisiran in clinical trials?

Lepodisiran has completed a phase 1 trial showing a significant reduction in Lp(a) levels, with a phase 2 trial currently underway[1].

How effective is obicetrapib in reducing LDL-C levels?

Obicetrapib reduced LDL-C levels by 33% compared to placebo at day 84 in its phase 3 BROADWAY clinical trial[3].

What is the role of lipid nanoparticles in drug delivery?

Lipid nanoparticles are crucial for delivering nucleic acids like mRNA, DNA, or RNA-based medicines efficiently, ensuring they are transported to target cells or tissues while being shielded from degradation[2][5].

What are the key drivers of the lipid nanoparticles market?

The key drivers include the growing burden of chronic diseases, advancements in gene therapy and nanotechnology, and increasing government and private investments in these areas[5].

What are the challenges facing the lipid nanoparticles market?

High formulation costs, limited loading capacity, and stringent regulatory compliance are significant challenges[5].

Sources

1. Cleveland Clinic Newsroom: "Trial Shows a Single Dose of an Experimental Therapy Reduces Lipoprotein(a)..."
2. Precedence Research: "Lipid Nanoparticles Market Size, Share and Trends 2024 to 2034"
3. NewAmsterdam Pharma: "NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3 BROADWAY Clinical Trial"
4. Verve Therapeutics: "Verve Therapeutics Announces Updates on its PCSK9 Program"
5. Mordor Intelligence: "Lipid Nanoparticles Market Size & Share Analysis - Growth Trends"