CLINICAL TRIALS PROFILE FOR LIRAGLUTIDE RECOMBINANT

All Clinical Trials for Liraglutide Recombinant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154401 ↗	Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 2	2005-01-01	This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
NCT00154414 ↗	Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 2	2005-01-01	This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
NCT00294723 ↗	To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c	Terminated	Novo Nordisk A/S	Phase 3	2006-02-01	This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).
NCT00318422 ↗	Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2006-05-01	This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.
NCT00318461 ↗	To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together	Completed	Novo Nordisk A/S	Phase 3	2006-05-01	This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Clinical Trial Conditions for Liraglutide Recombinant

Condition Name

Condition Name for Liraglutide Recombinant
Intervention	Trials
Diabetes Mellitus, Type 2	109
Diabetes	109
Obesity	85
Type 2 Diabetes	45

Condition MeSH

Condition MeSH for Liraglutide Recombinant
Intervention	Trials
Diabetes Mellitus	229
Diabetes Mellitus, Type 2	205
Diabetes Mellitus, Type 1	36
Obesity	35

Clinical Trial Locations for Liraglutide Recombinant

Trials by Country

Trials by Country for Liraglutide Recombinant
Location	Trials
Canada	142
India	133
China	118
South Africa	63
Denmark	60

Trials by US State

Trials by US State for Liraglutide Recombinant
Location	Trials
California	66
Texas	61
Florida	59
New York	57
Ohio	50

Clinical Trial Progress for Liraglutide Recombinant

Clinical Trial Phase

Clinical Trial Phase for Liraglutide Recombinant
Clinical Trial Phase	Trials
Phase 4	114
Phase 3	106
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for Liraglutide Recombinant
Clinical Trial Phase	Trials
Completed	271
Recruiting	50
Unknown status	37

Clinical Trial Sponsors for Liraglutide Recombinant

Sponsor Name

Sponsor Name for Liraglutide Recombinant
Sponsor	Trials
Novo Nordisk A/S	181
Eli Lilly and Company	10
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	9

Sponsor Type

Sponsor Type for Liraglutide Recombinant
Sponsor	Trials
Other	388
Industry	243
NIH	18

Liraglutide Recombinant: Clinical Trials, Market Analysis, and Projections

Introduction to Liraglutide

Liraglutide, a recombinant polypeptide, is a glucagon-like peptide-1 (GLP-1) receptor agonist used primarily in the treatment of type 2 diabetes and chronic obesity. It is marketed under the brand names Victoza and Saxenda.

Mechanism and Therapeutic Areas

Liraglutide works by mimicking the action of the natural hormone GLP-1, enhancing glucose-dependent insulin secretion, suppressing inappropriate glucagon secretion, and slowing gastric emptying. This mechanism helps in improving glycemic control, reducing body weight, and decreasing cardiovascular risk[3].

Key Therapeutic Areas

• Type 2 Diabetes: Liraglutide is approved for the treatment of type 2 diabetes to improve glycemic control.
• Obesity: A higher dose of liraglutide (3.0 mg) is approved for the treatment of obesity.
• Cardiovascular Outcomes: Liraglutide has been shown to positively affect cardiovascular outcomes in individuals with type 2 diabetes[3].

Clinical Trials Update

Recent Studies and Findings

• Cardiovascular Stability: A randomized clinical trial compared the effects of liraglutide versus placebo on time to death and rehospitalization for heart failure. The study found no significant differences in the primary end points, but it did note fewer hyperglycemic events in the liraglutide group[4].
• Alcohol Use Disorder (AUD): A study indicated that liraglutide, along with semaglutide, was associated with a lower risk of AUD hospitalization. Liraglutide users had an adjusted hazard ratio of 0.72 for AUD hospitalization[1].
• Osteogenic Differentiation: Research has also explored liraglutide's effects on rat bone marrow mesenchymal stem cells, showing its potential in osteogenic differentiation and related regulatory mechanisms[1].

Ongoing Investigations

• New Formulations: Efforts are ongoing to develop an oral formulation of liraglutide and its analog semaglutide, which could improve treatment adherence. Semaglutide is currently in phase 3 clinical development for an oral formulation for type 2 diabetes[3].
• Additional Indications: Liraglutide and semaglutide are being investigated for new indications, including non-alcoholic fatty liver disease (NASH) and other metabolic disorders[3].

Market Analysis

Market Size and Growth

The liraglutide market is projected to grow significantly. Here are some key market statistics:

• Current Market Size: The liraglutide market size was estimated at USD 3.40 billion in 2024[5].
• Projected Growth: The market is expected to reach USD 3.51 billion in 2025 and grow at a CAGR of 3.16% to reach USD 4.10 billion by 2030[5].

Market Segmentation

• Geographical Segmentation: The market is segmented geographically into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. North America accounts for the largest market share and is expected to grow at the highest CAGR over the forecast period[5].
• Brand Segmentation: Liraglutide is sold under the brand names Victoza and Saxenda, with these brands driving the market growth[5].

Key Players

• Novo Nordisk A/S: Novo Nordisk is the major player in the liraglutide market, responsible for the development, manufacturing, and distribution of Victoza and Saxenda[5].

Technological Advancements

Production Technology

AVVA Pharmaceuticals Ltd has developed advanced technology for the production of liraglutide, including:

• Recombinant Plasmid DNA: For fusion protein expression.
• Specific Kanamycin-resistant E. coli Strain: This reduces contamination risk, increases protein yield, and optimizes purification processes[2].

Market News and Partnerships

• Biocon and Juno Pharmaceuticals Partnership: Biocon has partnered with Juno Pharmaceuticals for the commercialization of liraglutide in the Canadian market, focusing on type 2 diabetes and obesity treatment[5].
• Supply Agreement in New Zealand: Due to a global supply issue of dulaglutide, Pharmac in New Zealand has funded liraglutide as an alternative treatment for type 2 diabetes[5].

Sales and Market Performance

• Sales Volume: In 2021, 21.7 million packs of liraglutide were sold, with a total market value of USD 6.1 billion[2].
• Regulatory Approvals: Liraglutide was first approved in the EU in 2009 and later in the USA in 2010[1].

Key Takeaways

• Clinical Efficacy: Liraglutide has shown significant clinical efficacy in managing type 2 diabetes, obesity, and cardiovascular outcomes.
• Market Growth: The liraglutide market is expected to grow steadily, driven by increasing demand and technological advancements.
• Technological Innovations: Advanced production technologies and ongoing research into new formulations and indications are key drivers of the market.
• Partnerships and Collaborations: Strategic partnerships are enhancing the global reach and availability of liraglutide.

FAQs

What is the primary mechanism of action of liraglutide?

Liraglutide works by mimicking the action of the natural hormone GLP-1, enhancing glucose-dependent insulin secretion, suppressing inappropriate glucagon secretion, and slowing gastric emptying[3].

Which are the main therapeutic areas for liraglutide?

Liraglutide is primarily used in the treatment of type 2 diabetes and chronic obesity, with additional benefits in cardiovascular outcomes[3].

What is the projected market size of liraglutide by 2030?

The liraglutide market is expected to reach USD 4.10 billion by 2030, growing at a CAGR of 3.16% from 2025[5].

Who are the major players in the liraglutide market?

Novo Nordisk A/S is the major player in the liraglutide market, responsible for the development, manufacturing, and distribution of Victoza and Saxenda[5].

What are the recent advancements in liraglutide production technology?

Recent advancements include the use of a specific kanamycin-resistant E. coli strain, which reduces contamination risk, increases protein yield, and optimizes purification processes[2].

Are there any ongoing clinical trials or investigations for new indications of liraglutide?

Yes, ongoing efforts include the development of an oral formulation and investigations into new indications such as non-alcoholic fatty liver disease (NASH)[3].