CLINICAL TRIALS PROFILE FOR BYDUREON

505(b)(2) Clinical Trials for BYDUREON

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT04520490 ↗	Brain Activation and Satiety in Children 2	Recruiting	University of Washington	Phase 3	2021-01-28	Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.
New Combination	NCT04520490 ↗	Brain Activation and Satiety in Children 2	Recruiting	Seattle Children's Hospital	Phase 3	2021-01-28	Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.

All Clinical Trials for BYDUREON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01089569 ↗	Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine	Completed	International Diabetes Center at Park Nicollet	N/A	2010-04-01	The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
NCT01089569 ↗	Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine	Completed	Sanofi	N/A	2010-04-01	The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
NCT00877890 ↗	A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)	Completed	Eli Lilly and Company	Phase 3	2009-03-01	This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
NCT00877890 ↗	A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)	Completed	AstraZeneca	Phase 3	2009-03-01	This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
NCT00308139 ↗	Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)	Completed	AstraZeneca	Phase 3	2006-04-01	A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.
NCT00103935 ↗	Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 2	2005-02-01	Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.
NCT00103935 ↗	Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes	Completed	AstraZeneca	Phase 2	2005-02-01	Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

Clinical Trial Conditions for BYDUREON

Condition Name

Condition Name for BYDUREON
Intervention	Trials
Type 2 Diabetes	8
Type 2 Diabetes Mellitus	6
Obesity	4
Diabetes Mellitus, Type 2	4

Condition MeSH

Condition MeSH for BYDUREON
Intervention	Trials
Diabetes Mellitus, Type 2	18
Diabetes Mellitus	14
Obesity	5
Atherosclerosis	2

Clinical Trial Locations for BYDUREON

Trials by Country

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−

Trials by Country for BYDUREON
Location	Trials
United States	136
Israel	2
China	2
Mexico	2
Kuwait	2

Trials by US State

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−

Trials by US State for BYDUREON
Location	Trials
Texas	12
Florida	8
California	8
Washington	7
New York	7

Clinical Trial Progress for BYDUREON

Clinical Trial Phase

Clinical Trial Phase for BYDUREON
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	10
Phase 2	7

Clinical Trial Status

Clinical Trial Status for BYDUREON
Clinical Trial Phase	Trials
Completed	23
Recruiting	6
Unknown status	4

Clinical Trial Sponsors for BYDUREON

Sponsor Name

Sponsor Name for BYDUREON
Sponsor	Trials
AstraZeneca	9
The University of Texas Health Science Center, Houston	4
Eli Lilly and Company	2

Sponsor Type

Sponsor Type for BYDUREON
Sponsor	Trials
Other	40
Industry	15
U.S. Fed	2

BYDUREON: Clinical Trials, Market Analysis, and Projections

Introduction to BYDUREON

BYDUREON, developed by AstraZeneca, is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist used in the treatment of type 2 diabetes. It is an extended-release formulation of exenatide, which has been a cornerstone in diabetes management since its introduction.

Clinical Trials Overview

DURATION-4 Study

One of the significant clinical trials for BYDUREON is the DURATION-4 study. This 26-week, double-blind, randomized trial compared BYDUREON monotherapy to other commonly prescribed oral type 2 diabetes medications: Januvia (sitagliptin), Actos (pioglitazone), and metformin. The study enrolled 820 patients who were not achieving adequate glycemic control through diet and exercise alone.

• Efficacy: Patients treated with BYDUREON showed a reduction in A1C levels of 1.5 percentage points from baseline, which was significantly greater than the reduction seen with Januvia (1.2 percentage points). Metformin and Actos also showed reductions of 1.5 and 1.6 percentage points, respectively. The majority of patients in all treatment arms achieved an optimal A1C goal of less than 7 percent[1].

• Weight Loss: BYDUREON treatment resulted in an average weight loss of 4.5 pounds, significantly greater than the weight loss seen with Januvia (1.7 pounds) and in contrast to the weight gain seen with Actos (3.3 pounds). Metformin users experienced an average weight loss of 4.4 pounds[1].

• Safety and Tolerability: The study reported no major hypoglycemia events in any treatment group. The most frequently reported adverse events among BYDUREON users were nausea and diarrhea, with a withdrawal rate of less than 1 percent[1].

Trials in Children and Adolescents

A recent phase 3 trial presented at the American Diabetes Association’s 81st Scientific Sessions marked a significant milestone for BYDUREON. This trial was the first to complete in children and adolescents with type 2 diabetes.

• Efficacy in Younger Patients: The trial demonstrated that BYDUREON reduced A1C levels over 24 weeks, with recipients showing an average A1C reduction of 0.36%, compared to a 0.49% increase in the placebo group. This reduction was significant despite the patients being treated with metformin and insulin[3][4].

• Safety and Weight Change: The trial showed that BYDUREON was safe and well-tolerated in younger patients, with a small difference in body weight change. The BYDUREON group lost an average of 1.3 pounds, while the placebo group gained an average of 1.4 pounds[3][4].

Market Analysis

Current Market Size and Growth

The GLP-1 receptor agonist market, which includes BYDUREON, is experiencing robust growth. As of 2024, the global market size for GLP-1 receptor agonists is estimated to be around USD 25.3 billion. This market is projected to expand to USD 91.53 billion by 2035, with a compound annual growth rate (CAGR) of 12.4% between 2025 and 2035[2].

Market Segments and Drivers

• Diabetes Treatment: The largest segment in the GLP-1 receptor agonist market is diabetes treatment, driven by the global prevalence of type 2 diabetes. The increasing number of diabetes cases worldwide, particularly in regions like North America and the Asia Pacific, is a significant driver of this market[2][5].

• Obesity Management: The fastest-growing segment is obesity management, fueled by rising obesity rates and the adoption of GLP-1 therapies like Wegovy for weight loss. This expansion highlights the versatility of GLP-1 receptor agonists beyond diabetes management[2].

• Emerging Markets: Expansion into emerging markets with growing diabetes burdens and improving healthcare infrastructure is another key growth opportunity. The development of combination therapies for diabetes and cardiovascular risk management also contributes to market growth[2].

Regional Contribution

North America is expected to make a notable contribution to the global GLP-1 receptor agonist market due to high diabetes and obesity prevalence, robust healthcare infrastructure, and early adoption of advanced therapies. The Asia Pacific region is identified as the fastest-growing market, driven by increasing healthcare needs and infrastructure development[2].

Market Projections

Future Market Size

By 2035, the GLP-1 receptor agonist market is projected to reach USD 91.53 billion, up from USD 25.3 billion in 2024. This growth is driven by several factors, including the increasing prevalence of diabetes, the expanding use of GLP-1 receptor agonists in obesity management, and the development of new therapeutic applications[2].

Competitive Landscape

The market is highly competitive, with several key players including AstraZeneca (BYDUREON), Eli Lilly (Trulicity), Merck (Januvia), and Novo Nordisk (Victoza and Ozempic). Despite the competition, BYDUREON's unique once-weekly dosing and its approval for use in children and adolescents position it as a significant player in the market[3].

Key Takeaways

• Clinical Efficacy: BYDUREON has demonstrated significant efficacy in reducing A1C levels and promoting weight loss in both adult and younger patient populations.
• Market Growth: The GLP-1 receptor agonist market is expected to grow substantially, driven by increasing diabetes prevalence, expanding therapeutic applications, and growth in emerging markets.
• Competitive Advantage: BYDUREON's once-weekly dosing and recent approvals for use in children and adolescents provide a competitive edge in the market.
• Safety and Tolerability: The drug has shown a favorable safety and tolerability profile in clinical trials.

FAQs

What is BYDUREON used for?

BYDUREON is used for the treatment of type 2 diabetes, helping to reduce blood sugar levels and promote weight loss.

How does BYDUREON compare to other diabetes medications?

In clinical trials, BYDUREON has shown comparable or superior efficacy to other commonly prescribed diabetes medications like Januvia, Actos, and metformin in reducing A1C levels and promoting weight loss[1].

Is BYDUREON approved for use in children and adolescents?

Yes, BYDUREON has been approved for use in children and adolescents with type 2 diabetes, making it the first once-weekly GLP-1 receptor agonist to achieve this milestone[3][4].

What are the common side effects of BYDUREON?

Common side effects of BYDUREON include nausea and diarrhea, with a low withdrawal rate due to adverse events[1].

How is the GLP-1 receptor agonist market expected to grow?

The GLP-1 receptor agonist market is expected to grow from USD 25.3 billion in 2024 to USD 91.53 billion by 2035, with a CAGR of 12.4% between 2025 and 2035[2].

Sources

1. Eli Lilly Investor Relations: DURATION-4 Study Results: BYDUREON Efficacy and Tolerability.
2. MetaTech Insights: GLP-1 Receptor Agonist Market Share, Size, Trends 2025-2035.
3. FiercePharma: ADA 2021: AstraZeneca touts Bydureon trial win in children and adolescents with type 2 diabetes.
4. AstraZeneca US: BYDUREON BCise (exenatide extended-release) approved in the US for the treatment of type 2 diabetes.
5. Biospace: GLP-1 Receptor Agonist Market worth $55.70 Billion by 2031.