CLINICAL TRIALS PROFILE FOR LIRAGLUTIDE

All Clinical Trials for liraglutide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
NCT00331851 ↗	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 in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.
NCT00333151 ↗	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 in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.
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).
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.

Clinical Trial Conditions for liraglutide

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for liraglutide

Trials by Country

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

Trials by US State

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−

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

Clinical Trial Progress for liraglutide

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for liraglutide

Sponsor Name

Sponsor Name for liraglutide
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
Sponsor	Trials
Other	388
Industry	243
NIH	18

Liraglutide: Clinical Trials, Market Analysis, and Projections

Introduction

Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been a significant player in the treatment of type 2 diabetes and obesity. Developed by Novo Nordisk, this drug has undergone extensive clinical trials and has seen substantial market growth. Here, we will delve into the recent clinical trials, market analysis, and future projections for liraglutide.

Clinical Trials Overview

STRIVE Trial

The STRIVE trial, a multicentre, open-label, randomized controlled trial, is a landmark study that demonstrated the efficacy of a targeted prescribing pathway for liraglutide 3 mg in managing obesity. Conducted from November 2017 to February 2020, the trial involved 434 participants, with 392 randomized into either the intervention or control groups. The results showed that more participants in the intervention group achieved a weight loss of ≥15% at 52 weeks compared to the control group (25.4% vs 6.5%, respectively)[1].

SCALE Trials

The FDA's approval of Saxenda (liraglutide) for obesity treatment was based on the SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Nondiabetic and Diabetic people) clinical trials. These Phase III trials, which lasted 56 weeks, enrolled over 5,000 participants and evaluated the safety and efficacy of liraglutide in obese or overweight individuals, with or without other weight-related conditions. The trials confirmed the drug's ability to induce significant weight loss and improve glycemic control[4].

Bioequivalence and Safety Trials

A recent clinical trial evaluated the bioequivalence and safety of a liraglutide injection manufactured by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. and Hangzhou Jiuyuan Gene Engineering Co., Ltd. The study, conducted in healthy subjects, showed that the pharmacokinetics of the test drug were bioequivalent to the original Victoza® formulation, with both formulations exhibiting a favorable safety profile. No serious adverse reactions were reported, and all adverse events were mild and resolved without treatment[3].

Market Analysis

Sales Growth and Market Expansion

Liraglutide sales have seen a steady increase from 2016 to 2020, particularly after its inclusion in the medical insurance reimbursement catalog in China in 2017. The sales value grew from CNY51.98 million in 2017 to CNY114.39 million in 2018, representing a 120.05% annual growth rate. Despite the impact of the COVID-19 pandemic, the sales value reached CNY286.73 million in 2020, with a compound annual growth rate (CAGR) of 61.87% from 2016 to 2020[2][5].

Competitive Landscape

The expiration of liraglutide's patent has led to an increase in the number of manufacturers. For instance, the drug registration application for liraglutide injection produced by Shenzhen Hanyu Pharmaceutical Co., Ltd. was accepted in 2019. This increase in competition is expected to drive market expansion and reduce prices, further boosting sales and market volume[2][5].

Impact of COVID-19

The COVID-19 pandemic had a moderate impact on liraglutide sales, with a lower growth rate in 2020 compared to previous years. However, analysts expect a recovery in sales growth from 2021 to 2025 as the pandemic's effects alleviate[5].

Market Projections

Future Growth

The market for liraglutide is projected to continue growing from 2021 to 2025. The huge patient population, particularly in China where 1 in 10 adults has diabetes and over 90% of these are type 2 diabetic patients, will drive demand. The increasing number of manufacturers and the expected decline in prices will also contribute to market expansion[2][5].

Regional and Manufacturer-Specific Trends

The market analysis indicates that regional differences in pricing and availability will influence the sales of liraglutide. For example, the approval of biosimilar versions, such as the one by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., will increase accessibility and reduce costs, making the drug more appealing to a broader patient base[3][5].

Key Benefits and Implications

Clinical Effectiveness

Liraglutide has been shown to be highly effective in achieving significant weight loss and improving glycemic control. The targeted prescribing pathway, as demonstrated in the STRIVE trial, enhances the drug's efficacy by ensuring that patients who do not meet certain weight loss milestones can adjust their treatment plan accordingly[1].

Personalized Medicine

The use of a targeted prescribing pathway aligns with the concept of personalized medicine, allowing for more tailored and cost-effective treatment strategies. This approach can help optimize the use of liraglutide, ensuring that patients receive the most beneficial treatment while minimizing unnecessary costs[1].

Cardiovascular and Metabolic Benefits

In addition to weight loss and glycemic control, liraglutide has been shown to delay β-cell failure, reduce cardiovascular complications, and improve lipid metabolism. These benefits make it a valuable treatment option for patients with type 2 diabetes and obesity[3].

Adverse Events and Safety Profile

Common Adverse Events

Clinical trials have identified common adverse events associated with liraglutide, including gastrointestinal symptoms such as nausea, vomiting, and diarrhea. However, most adverse events are mild and transient, with no serious adverse reactions reported in recent studies[1][3].

Conclusion

Liraglutide has established itself as a potent treatment for type 2 diabetes and obesity, backed by robust clinical trials and a growing market presence. The drug's efficacy in achieving significant weight loss and improving metabolic outcomes, combined with its favorable safety profile, makes it a valuable asset in the management of these conditions.

Key Takeaways

• Clinical Efficacy: Liraglutide has been shown to be highly effective in achieving ≥15% weight loss and improving glycemic control.
• Market Growth: Sales of liraglutide have increased significantly from 2016 to 2020, with a projected recovery and growth from 2021 to 2025.
• Competitive Landscape: The expiration of the patent and increasing number of manufacturers are expected to expand the market and reduce prices.
• Personalized Medicine: The use of targeted prescribing pathways aligns with personalized medicine, optimizing treatment and cost-effectiveness.
• Safety Profile: Liraglutide has a favorable safety profile, with most adverse events being mild and transient.

FAQs

What is the primary indication for liraglutide?

Liraglutide is primarily indicated for the treatment of type 2 diabetes and obesity, with additional benefits in delaying β-cell failure and reducing cardiovascular complications.

How effective is liraglutide in weight loss?

Clinical trials, such as the STRIVE and SCALE trials, have shown that liraglutide can achieve significant weight loss, with up to 25.4% of participants achieving a weight loss of ≥15% at 52 weeks.

What are the common adverse events associated with liraglutide?

Common adverse events include gastrointestinal symptoms such as nausea, vomiting, and diarrhea, but most are mild and transient.

How has the COVID-19 pandemic affected liraglutide sales?

The pandemic had a moderate impact on sales, but analysts expect a recovery in sales growth from 2021 to 2025 as the pandemic's effects alleviate.

What is the expected market trend for liraglutide from 2021 to 2025?

The market is projected to grow, driven by the increasing number of manufacturers, declining prices, and a large patient population, particularly in China.

Sources

1. The Lancet: "STRIVE: A multicentre, open-label, parallel-group, randomized controlled trial to investigate the clinical effectiveness of a targeted prescribing pathway for liraglutide 3 mg as adjunct to standard care in specialist weight management services (SWMS) vs standard SWMS care alone."
2. ResearchAndMarkets: "Investigation Report on China's Liraglutide Market 2021-2025."
3. Frontiers in Pharmacology: "Evaluating the bioequivalence and safety of liraglutide injection."
4. Clinical Trials Arena: "Saxenda (liraglutide) for the Treatment of Obesity, US."
5. Business Wire: "Investigation Report on China's Liraglutide Markets, 2016-2020, 2021-2025."