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Last Updated: December 30, 2025

CLINICAL TRIALS PROFILE FOR LIRAGLUTIDE


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All Clinical Trials for liraglutide

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for liraglutide

Condition Name

Condition Name for liraglutide
Intervention Trials
Diabetes Mellitus, Type 2 111
Diabetes 109
Obesity 94
Type 2 Diabetes 47
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Condition MeSH

Condition MeSH for liraglutide
Intervention Trials
Diabetes Mellitus 230
Diabetes Mellitus, Type 2 212
Obesity 47
Diabetes Mellitus, Type 1 37
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Clinical Trial Locations for liraglutide

Trials by Country

Trials by Country for liraglutide
Location Trials
Canada 145
India 134
China 126
South Africa 64
Denmark 60
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Trials by US State

Trials by US State for liraglutide
Location Trials
California 66
Texas 61
Florida 61
New York 57
Ohio 53
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Clinical Trial Progress for liraglutide

Clinical Trial Phase

Clinical Trial Phase for liraglutide
Clinical Trial Phase Trials
PHASE4 13
PHASE3 2
PHASE2 4
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Clinical Trial Status

Clinical Trial Status for liraglutide
Clinical Trial Phase Trials
Completed 274
RECRUITING 65
Unknown status 37
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Clinical Trial Sponsors for liraglutide

Sponsor Name

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

Sponsor Type for liraglutide
Sponsor Trials
Other 431
Industry 250
NIH 20
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LIRAGLUTIDE: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 27, 2025


Introduction

Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has secured its position in the therapeutic landscape for type 2 diabetes (T2D), obesity, and cardiovascular risk reduction. Originally developed by Novo Nordisk under brand names such as Victoza and Saxenda, liraglutide’s expansion into new indications and evolving clinical evidence have significantly influenced its market dynamics. This article consolidates recent clinical trial developments, provides an in-depth market analysis, and projects future industry trends concerning liraglutide.


Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past two years, liraglutide has been subjected to a robust pipeline of clinical investigations, expanding its application scope beyond traditional T2D management.

  • LEADER Trial (2016): A landmark cardiovascular outcomes trial demonstrating a significant reduction in major adverse cardiovascular events (MACE) among high-risk T2D patients. The trial paved the way for liraglutide’s label expansion to include cardiovascular risk mitigation.[1]

  • SELECT Trial (2021): Focused on liraglutide’s efficacy in obesity management, particularly in non-diabetic populations with obesity or overweight with weight-related comorbidities. Results indicated a notable weight reduction of approximately 15%, along with improvements in cardiometabolic parameters. It is still ongoing, with topline results anticipated soon.[2]

  • Phase 3 OBESITY Trials: Multiple trials are exploring liraglutide’s role in weight management for adolescents and elderly populations, aiming for regulatory approval beyond adult markets.

  • Neurodegenerative and NASH Trials: Recent exploratory studies assess liraglutide's potential in non-traditional indications such as Alzheimer's disease and non-alcoholic steatohepatitis (NASH), reflecting interest in its neuroprotective and metabolic effects.

Regulatory Approvals and Label Expansions

  • European Medicines Agency (EMA): Approved liraglutide (Victoza) for reducing the risk of cardiovascular events in adults with T2D and established cardiovascular disease.

  • FDA Approvals: While Saxenda (liraglutide 3.0 mg) received FDA approval for chronic weight management, the agency continues to evaluate additional indications based on emerging data.

  • Upcoming Regulatory Review: The results from the SELECT trial might heighten the likelihood of liraglutide securing approval for obesity in the United States and other jurisdictions, particularly as weight management remains a significant unmet medical need.


Market Analysis

Market Landscape Overview

Liraglutide occupies a leading position among GLP-1 receptor agonists, which have revolutionized T2D and obesity treatment paradigms. As of 2022, the global GLP-1 market is valued at approximately USD 10 billion and is projected to grow at a CAGR of 10-12% through 2030.[3] Liraglutide’s market share, estimated at around 35%, is driven by its proven cardiovascular benefits, multiple indications, and favorable safety profile.

Competitive Market Dynamics

  • Main Competitors: Semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and exenatide are primary rivals, with semaglutide gaining dominance due to superior efficacy in weight loss and glycemic control.

  • Pricing and Reimbursement: With high efficacy comes high costs; liraglutide’s annual treatment expenses range from USD 8,000 to 12,000. Reimbursement policies vary globally, influencing market penetration.

  • Off-Label Use and Patient Preferences: The convenience of once-weekly injections for semaglutide ahead of daily liraglutide formulations poses challenges, yet liraglutide's established safety and cardiovascular data maintain its strategic relevance.

Emerging Markets and Access

  • Developing Economies: Increasing prevalence of T2D and obesity is stimulating demand, but affordability and healthcare infrastructure are limiting factors.

  • Innovative Delivery Platforms: The development of pen-injectors and potential oral formulations may mitigate twiddled adherence issues and expand market share.

Regulatory and Reimbursement Trends

Regulatory agencies are increasingly emphasizing cardiovascular outcomes, favoring liraglutide’s existing data. Governments are also adopting value-based pricing models aligning reimbursement with proven outcomes, benefitting drugs with robust clinical evidence like liraglutide.


Market Projections

Forecast for the Next Decade

  • Growth in T2D and Obesity Population: The global adult T2D population is projected to reach 700 million by 2045, with obesity prevalence doubling in many countries.[4] This demographic trend warrants sustained demand for GLP-1 therapies.

  • Product Pipeline Expansion: Positive topline data from ongoing trials (e.g., SELECT) could prompt regulatory approvals in obesity management, significantly broadening liraglutide’s target population.

  • Market Share Trends: While semaglutide is poised to capture a lion’s share due to efficacy advantages, liraglutide’s familiarity, cardiovascular benefits, and established safety profile ensure continued relevance, especially among patients with high cardiovascular risk.

  • Revenue Projections: The global liraglutide market is expected to reach USD 5-6 billion annually by 2030, with compounded growth driven by obesity indications and expanded cardiovascular labeling.

Potential Disruptors and Opportunities

  • Emerging Oral GLP-1 Analogs: Oral formulations, such as semaglutide’s oral counterpart, threaten injectable GLP-1 dominance but also create opportunities for combination therapies.

  • Personalized Medicine: Biomarker-driven patient stratification can optimize liraglutide’s use, improving outcomes and cost-effectiveness.

  • Strategic Partnerships: Collaborations with healthcare providers and payers can facilitate broader access, especially in emerging markets.


Conclusion and Key Takeaways

Liraglutide remains a pivotal therapeutic agent within the GLP-1 receptor agonist class. Recent clinical trials reinforce its multifaceted efficacy — from glycemic control and weight loss to cardiovascular risk reduction. The upcoming data, particularly from the SELECT trial, could significantly influence its market positioning, especially in obesity management.

Market growth projections remain optimistic, underpinned by rising global diabetes and obesity burdens, though competitive pressures from semaglutide and innovation in delivery platforms pose challenges. Strategic differentiation through demonstrated safety, broad indication labels, and evolving healthcare policies will determine liraglutide’s sustained market leadership.

In conclusion, professionals should monitor emerging clinical data, regulatory developments, and market dynamics to inform investment and development strategies effectively.


Key Takeaways

  • Emerging clinical trial data, notably from the SELECT trial, could propel liraglutide’s expansion into obesity treatment, broadening its therapeutic scope.
  • The global market for liraglutide is forecasted to grow robustly, reaching USD 5-6 billion annually by 2030, driven by increasing disease prevalence.
  • Competitive pressures from short-acting and oral GLP-1 formulations necessitate continuous innovation and strategic positioning.
  • Reimbursement policies and healthcare infrastructure enhancements in emerging markets will be critical to volumetric growth.
  • Demonstrated cardiovascular benefits remain a substantial differentiator, especially among high-risk patient populations.

FAQs

1. What are the primary indications for liraglutide currently?
Liraglutide is approved for type 2 diabetes management, weight management in obesity, and cardiovascular risk reduction in patients with established CV disease.

2. How does liraglutide compare with semaglutide in efficacy?
Semaglutide generally exhibits superior efficacy in weight reduction and glycemic control, partly due to its pharmacokinetic profile allowing once-weekly dosing with higher potency.

3. Are there significant safety concerns associated with liraglutide?
Liraglutide’s safety profile is well-established, with side effects mainly gastrointestinal (nausea, vomiting). Rare risks include pancreatitis and thyroid C-cell tumors; hence, contraindications exist.

4. What factors could influence liraglutide’s market growth?
Factors include competitive drugs, regulatory approvals, pricing, reimbursement policies, patient preferences, and ongoing clinical trial outcomes.

5. Will liraglutide’s future be impacted by the development of oral GLP-1 therapies?
Potentially, yes. Oral formulations could enhance adherence and expand patient access, challenging injection-based therapies; however, clinical familiarity and existing data for liraglutide provide strategic advantages.


References

[1] Marso SP, et al. "Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes." New England Journal of Medicine, 2016.
[2] Data on ongoing SELECT trial (ClinicalTrials.gov) – Identifier NCT03853081.
[3] MarketsandMarkets. “GLP-1 Receptor Agonists Market by Drug Class, Therapeutic Application, Region - Global Forecast to 2030.” 2022.
[4] International Diabetes Federation. “IDF Diabetes Atlas, 10th Edition,” 2021.

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