CLINICAL TRIALS PROFILE FOR VICTOZA

All Clinical Trials for VICTOZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01232946 ↗	Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake	Completed	Novo Nordisk A/S	N/A	2012-01-01	27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).
NCT01232946 ↗	Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake	Completed	Indiana University	N/A	2012-01-01	27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).
NCT01226966 ↗	Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S		2010-09-01	This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.
NCT01029886 ↗	Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 3	2010-01-01	No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
NCT01029886 ↗	Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes	Completed	AstraZeneca	Phase 3	2010-01-01	No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
NCT00993720 ↗	Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes	Completed	Hvidovre University Hospital	Phase 2/Phase 3	2009-10-01	The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.

Clinical Trial Conditions for VICTOZA

Condition Name

Condition Name for VICTOZA
Intervention	Trials
Type 2 Diabetes	27
Type 2 Diabetes Mellitus	19
Obesity	18
Diabetes Mellitus, Type 2	9

Condition MeSH

Condition MeSH for VICTOZA
Intervention	Trials
Diabetes Mellitus	69
Diabetes Mellitus, Type 2	61
Diabetes Mellitus, Type 1	15
Overweight	7

Clinical Trial Locations for VICTOZA

Trials by Country

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Trials by Country for VICTOZA
Location	Trials
United States	168
China	29
Canada	25
Denmark	21
Germany	10

Trials by US State

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Trials by US State for VICTOZA
Location	Trials
California	13
New York	11
Texas	9
Florida	8
Ohio	7

Clinical Trial Progress for VICTOZA

Clinical Trial Phase

Clinical Trial Phase for VICTOZA
Clinical Trial Phase	Trials
Phase 4	45
Phase 3	22
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for VICTOZA
Clinical Trial Phase	Trials
Completed	80
Recruiting	12
Unknown status	12

Clinical Trial Sponsors for VICTOZA

Sponsor Name

Sponsor Name for VICTOZA
Sponsor	Trials
Novo Nordisk A/S	41
University of Copenhagen	5
Steno Diabetes Center	4

Sponsor Type

Sponsor Type for VICTOZA
Sponsor	Trials
Other	168
Industry	61
NIH	6

Clinical Trials, Market Analysis, and Projections for VICTOZA (Liraglutide)

Introduction to VICTOZA (Liraglutide)

VICTOZA, also known as liraglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk. It is used to treat type 2 diabetes and, in some cases, obesity. Here, we will delve into the current clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Ongoing and Upcoming Trials

Several clinical trials are currently underway or planned for liraglutide, focusing on various aspects of its efficacy and safety.

• SURPASS-CVOT and SURPASS-PEDS Trials:

  • The SURPASS-CVOT trial is examining the cardiovascular outcomes of tirzepatide, another GLP-1 receptor agonist, but it provides context for the broader class of medications that includes liraglutide. However, specific trials for liraglutide, such as the SURPASS-PEDS trial, are focused on children aged 10-17 years with type 2 diabetes. This trial aims to assess the change in A1c levels over 30 weeks, with an expected completion date moved up to February 2025[1].

• SURMOUNT Trials:

  • The SURMOUNT trials are a series of studies evaluating tirzepatide, but they are relevant in understanding the competitive landscape and potential future directions for liraglutide. For instance, the SURMOUNT-5 trial is comparing tirzepatide with semaglutide (another GLP-1 receptor agonist) in terms of weight reduction, with an expected completion date in November 2024[1].

• Cardiovascular Outcomes:

  • Trials focusing on cardiovascular outcomes are crucial for liraglutide. For example, studies have shown that liraglutide reduces the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease[3].

Adverse Reactions and Safety

Clinical trials and postmarketing reports have highlighted several adverse reactions associated with liraglutide, including nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. More serious adverse events include pancreatitis, acute renal failure, and the potential risk of medullary thyroid carcinoma (MTC), although the latter's causal relationship with liraglutide is still under investigation[3].

Market Analysis

Market Size and Growth

The liraglutide market, primarily driven by the brand Victoza, is expected to see significant growth. By 2025, the market is projected to reach USD 3.51 billion and is anticipated to grow at a CAGR of 3.16% to reach USD 4.10 billion by 2030. Victoza is expected to register the highest growth rate within this period, exceeding 4.21%[5].

Market Segmentation

The liraglutide market is segmented by brand and geography.

• Brand Segmentation:

  • Victoza and Saxenda are the primary brands under which liraglutide is marketed. Victoza is used for type 2 diabetes and cardiovascular risk reduction, while Saxenda is primarily used for obesity management[5].

• Geographical Segmentation:

  • The market is divided into regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. China, in particular, has seen significant growth in the liraglutide market, with Novo Nordisk being the sole manufacturer in the Chinese market as of 2020[2].

Market Drivers and Challenges

• Drivers:

  • The increasing prevalence of type 2 diabetes and obesity, coupled with the effective alleviation of COVID-19 impacts, are driving the growth of the liraglutide market. The medication's ability to reduce cardiovascular risk and improve glycemic control are key factors[2][5].

• Challenges:

  • Market challenges include the potential for adverse reactions, the need for continuous monitoring, and the presence of competitors within the GLP-1 receptor agonist class. Additionally, market threats such as the impact of generic versions and regulatory hurdles can affect market dynamics[2][5].

Market Projections

Generic Competition

The recent FDA approval of the first generic daily GLP-1 injection referencing liraglutide is expected to impact the market. This approval addresses ongoing shortages of GLP-1 agonists and provides a more affordable option for patients, which could influence market share and pricing strategies for branded products like Victoza[4].

Future Growth

Despite the introduction of generics, the liraglutide market is projected to grow due to its established efficacy and the expanding patient population. The medication's use in both type 2 diabetes and obesity management, along with its cardiovascular benefits, will continue to drive demand.

Regional Expansion

The Chinese market, in particular, is expected to see significant growth. The report on China's liraglutide market indicates a recovery growth from 2021 to 2025, driven by the effective management of COVID-19 and increasing healthcare spending[2].

Key Takeaways

• Clinical Trials: Ongoing trials are focusing on various aspects of liraglutide's efficacy and safety, including cardiovascular outcomes and pediatric use.
• Market Growth: The liraglutide market is projected to reach USD 3.51 billion by 2025 and USD 4.10 billion by 2030, driven by Victoza.
• Market Segmentation: The market is segmented by brand (Victoza and Saxenda) and geography, with significant growth expected in regions like China.
• Generic Competition: The introduction of generic versions may impact market dynamics but is not expected to halt the overall growth of the liraglutide market.
• Future Prospects: The medication's established benefits in type 2 diabetes and obesity management, along with its cardiovascular risk reduction, will continue to drive demand.

FAQs

What is VICTOZA used for?

VICTOZA (liraglutide) is used as an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older with type 2 diabetes. It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease[3][4].

What are the common adverse reactions associated with VICTOZA?

Common adverse reactions include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. More serious adverse events can include pancreatitis and acute renal failure[3].

Is VICTOZA approved for use in children?

Yes, VICTOZA is approved for use in children aged 10 to 17 years with type 2 diabetes, making it the first GLP-1 receptor agonist approved for this age group[4].

What is the market projection for VICTOZA?

The liraglutide market, primarily driven by Victoza, is expected to reach USD 3.51 billion by 2025 and grow to USD 4.10 billion by 2030[5].

How does the introduction of generic versions affect the market?

The introduction of generic versions of liraglutide may impact market share and pricing strategies for branded products like Victoza, but it is not expected to halt the overall growth of the liraglutide market due to its established efficacy and expanding patient population[4].

Sources

1. 2024 Medication Update - Clinical Trials.gov
2. Investigation Report on China's Liraglutide Markets, 2016-2020 - ResearchAndMarkets.com
3. FDA Approval Document for VICTOZA - accessdata.fda.gov
4. FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes - AJMC
5. Liraglutide Market Size & Share Analysis - Mordor Intelligence