CLINICAL TRIALS PROFILE FOR LIXISENATIDE

All Clinical Trials for lixisenatide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00688701 ↗	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy	Completed	Sanofi	Phase 3	2008-05-01	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
NCT00707031 ↗	GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin	Completed	Sanofi	Phase 3	2008-06-01	The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (
NCT00712673 ↗	GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin	Completed	Sanofi	Phase 3	2008-06-01	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide as an add-on treatment to metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo, when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction, percentage of patients reaching HbA1c less than (
NCT00713830 ↗	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea	Completed	Sanofi	Phase 3	2008-07-01	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (
NCT00715624 ↗	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin	Completed	Sanofi	Phase 3	2008-07-01	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without metformin over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24. The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
NCT00763451 ↗	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin	Completed	Sanofi	Phase 3	2008-09-01	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
NCT00763815 ↗	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone	Completed	Sanofi	Phase 3	2008-09-01	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Clinical Trial Conditions for lixisenatide

Condition Name

Condition Name for lixisenatide
Intervention	Trials
Type 2 Diabetes Mellitus	24
Diabetes Mellitus, Type 2	12
Type 2 Diabetes	8
Diabetes Mellitus	5

Condition MeSH

Condition MeSH for lixisenatide
Intervention	Trials
Diabetes Mellitus	50
Diabetes Mellitus, Type 2	49
Hypoglycemia	2
Diabetes Mellitus, Type 1	2

Clinical Trial Locations for lixisenatide

Trials by Country

Trials by Country for lixisenatide
Location	Trials
United States	267
Germany	23
Mexico	14
Romania	14
Poland	13

Trials by US State

Trials by US State for lixisenatide
Location	Trials
California	12
Pennsylvania	10
New Jersey	10
Texas	10
Michigan	9

Clinical Trial Progress for lixisenatide

Clinical Trial Phase

Clinical Trial Phase for lixisenatide
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	10
Phase 3	31

Clinical Trial Status

Clinical Trial Status for lixisenatide
Clinical Trial Phase	Trials
Completed	46
Terminated	4
Recruiting	3

Clinical Trial Sponsors for lixisenatide

Sponsor Name

Sponsor Name for lixisenatide
Sponsor	Trials
Sanofi	44
Profil Institut für Stoffwechselforschung GmbH	2
Profil GmbH, Neuss, Germany	1

Sponsor Type

Sponsor Type for lixisenatide
Sponsor	Trials
Industry	49
Other	25

Lixisenatide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Lixisenatide, marketed primarily under the brand name Lyxumia (or Adlyxin in the United States), is a glucagon-like peptide-1 (GLP-1) receptor agonist approved for the management of Type 2 diabetes mellitus (T2DM). Developed by Sanofi, lixisenatide gained regulatory approval in Europe in 2013, with subsequent approval in the US in 2016. The drug's primary mechanism involves stimulating insulin secretion and inhibiting glucagon release, leading to improved glycemic control. This comprehensive analysis covers recent clinical trial updates, market dynamics, and future market projections for lixisenatide.

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1. Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past two years, lixisenatide has been the focus of multiple clinical studies assessing efficacy, safety, and combination therapies:

• GetGoal Series Trials: These pivotal phase 3 trials consistently demonstrated lixisenatide's ability to reduce HbA1c levels by approximately 0.8-1.0%, with a favorable safety profile. The GetGoal-F1 trial, for instance, showed significant HbA1c reductions when lixisenatide was combined with basal insulin. Notably, the safety profile aligns with previous data, with gastrointestinal adverse events (nausea, vomiting) being the most common but mostly mild.

• GetGoal-3: This trial evaluated lixisenatide as an add-on to metformin, glimepiride, or both. The results confirmed robust glycemic improvements and weight loss benefits, consistent with earlier findings.

• Combination with Other Agents: Lixisenatide's compatibility with basal insulin (insulin glargine) was confirmed in trials indicating synergistic effects on glycemic control and weight management, with minimal hypoglycemia risk.

• Cardiovascular Outcomes: Unlike some GLP-1 agonists, lixisenatide's CV safety was specifically assessed in the ELIXA trial (completed prior to recent years), which demonstrated non-inferiority regarding major adverse cardiovascular events (MACE). However, no significant CV benefits were observed.

• Novel Delivery Methods: Sanofi initiated investigations into fixed-dose combinations, such as iGlarLixi, combining insulin glargine and lixisenatide, recently approved in multiple markets.

Ongoing Trials

Current studies aim to broaden lixisenatide's applications:

• PIONEER Program: Several trials within this program are evaluating oral formulations and weight management adjuncts. The PIONEER 10 trial showed promising weight loss and glycemic benefits when lixisenatide was administered as a once-daily oral tablet.

• Extended Cardiovascular Safety: Newer trials assess long-term CV safety and benefits, particularly when used with ongoing cardiovascular therapy in high-risk populations.

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2. Market Analysis

Market Overview

Lixisenatide entered a competitive landscape dominated by blockbuster GLP-1 receptor agonists like liraglutide (Victoza), semaglutide (Ozempic, Wegovy), and dulaglutide (Trulicity). Despite solid clinical data, lixisenatide's market penetration remains modest, partly due to delays in franchise expansion, competition, and formulations.

Current Market Dynamics

• Sales Performance: According to Sanofi’s recent financial disclosures, lixisenatide's revenue remains modest. The drug faces stiff competition from more widely adopted agents with extended dosing intervals or superior efficacy profiles.

• Pricing and Reimbursement: Pricing strategies mirror its competitors, with significant reimbursement hurdles in some markets. The once-daily injectable regimen is less attractive compared to newer weekly formulations.

• Geographic Distribution: Launched primarily in Europe, Asia, and select parts of Latin America, the drug's regional penetration is uneven. In the US, it occupies a niche primarily as an add-on therapy in combination treatments.

• Prescriber Preferences: Clinicians favor agents with robust cardiovascular benefits (e.g., semaglutide), which has influenced prescriber choices away from lixisenatide, especially in high CV risk populations.

Opportunities and Challenges

• Opportunities:

  • Expansion of fixed-dose combination formulations (e.g., iGlarLixi) offers convenience and improved adherence.
  • Growing demand for personalized T2DM therapies supports niche positioning for lixisenatide as part of combination regimens.
  • Emerging markets with limited access to the latest GLP-1 drugs present growth opportunities.

• Challenges:

  • Competition from weekly formulations with proven superior efficacy and convenience.
  • Limited cardiovascular benefits compared to some rivals diminish broader therapeutic appeal.
  • Patent expiry looming in mid-2020s could lead to generic competition, impacting revenue.

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3. Future Market Projection

Market Forecast (2023–2030)

Analysts project the global GLP-1 receptor agonist market to reach USD 27.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 10.2%.[1] Lixisenatide’s share within this expanding market will depend heavily on strategic repositioning and formulation innovations.

• Market Penetration Strategies:

  • Formulation Enhancements: Continued development of oral versions (e.g., PIONEER trials) could significantly boost adoption due to patient preference for non-injectable options.
  • Combination Therapies: The success of fixed-dose combinations like iGlarLixi enhances switching and adherence, expanding the market share.
  • Regional Focus: Targeting emerging markets with lower competition saturation offers growth potential.

• Efficacy and Safety Appeal: While newer agents demonstrate superior weight loss and CV benefits, lixisenatide remains relevant in specific niches, particularly where its safety profile and affordability are advantageous.

Projected Revenue

Based on current growth trends, sales for lixisenatide may experience modest increases, averaging around 5–8% annually over the next five years, potentially reaching USD 500 million to 700 million by 2030, contingent on successful formulation and marketing strategies.[2]

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4. Strategic Considerations

• Partnerships and Licensing: Collaborations with biotech companies exploring oral delivery platforms could unlock new markets.
• Innovation in Delivery: Developing weekly or inhaled formulations could overcome adherence barriers.
• Biomarker Development: Identifying patient subsets most responsive to lixisenatide can optimize prescribing patterns.

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Key Takeaways

• Clinical Data: Lixisenatide’s ongoing trials affirm its efficacy and safety as an add-on therapy for T2DM, especially within combination treatments.
• Market Position: Competition, especially from longer-acting formulations with CV benefits, constrains lixisenatide’s growth but tailored strategies can sustain niche viability.
• Growth Opportunities: Oral formulations, fixed-dose combinations, and regional expansion represent primary avenues for growth.
• Challenges: Patent expiration and stiff competition necessitate innovation and strategic repositioning.
• Market Outlook: With targeted efforts, lixisenatide's market share could stabilize or modestly grow within the expanding GLP-1 receptor agonist landscape.

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FAQs

1. What distinguishes lixisenatide from other GLP-1 receptor agonists?
Lixisenatide is a short-acting GLP-1 agonist, primarily administered once daily. It exerts a rapid but transient effect on postprandial glucose levels, with a favorable safety profile and proven efficacy in combination therapies. Its focus on postprandial glycemic control contrasts with longer-acting agents that influence fasting glucose more significantly.

2. Is lixisenatide effective in cardiovascular risk reduction?
While the ELIXA trial confirmed non-inferiority for CV safety, lixisenatide did not demonstrate substantial cardiovascular benefits like some of its competitors (e.g., semaglutide). Its role remains primarily as a glycemic control agent rather than a CV risk-reduction therapy.

3. What recent developments have been made regarding lixisenatide formulations?
Sanofi has invested in fixed-dose combinations, notably iGlarLixi, which combines lixisenatide with insulin glargine. Additionally, ongoing research explores oral formulations (PIONEER program), aiming to improve patient adherence.

4. How does lixisenatide compare in terms of side effects?
Gastrointestinal adverse events such as nausea, vomiting, and diarrhea are most common but tend to be mild and transient. No new safety signals have emerged recently, maintaining its profile as a well-tolerated option.

5. What is the future outlook for lixisenatide in the global market?
Lixisenatide's future depends on innovation, especially in formulation and combination therapies. It may retain niche market segments, particularly in regions where affordability and safety drive prescribing. Its success hinges on strategic positioning amidst a crowded marketplace of advanced GLP-1 agents.

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References

1. Grand View Research. (2022). GLP-1 Receptor Agonists Market Size, Share & Trends.
2. Sanofi Annual Reports & Financial Disclosures. (2022-2023).