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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR EXENATIDE


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505(b)(2) Clinical Trials for Exenatide

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.
New Formulation NCT05347147 ↗ A Phase III Trial to Determine the Efficacy and Safety of Presendin in IIH Not yet recruiting Premier Research International LLC Phase 3 2022-06-01 Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.
New Formulation NCT05347147 ↗ A Phase III Trial to Determine the Efficacy and Safety of Presendin in IIH Not yet recruiting Invex Therapeutics Ltd. Phase 3 2022-06-01 Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Exenatide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00082381 ↗ Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin Completed Eli Lilly and Company Phase 3 2003-06-01 This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082381 ↗ Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin Completed AstraZeneca Phase 3 2003-06-01 This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 ↗ Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin Completed Eli Lilly and Company Phase 3 2003-11-01 This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 ↗ Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin Completed AstraZeneca Phase 3 2003-11-01 This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00085969 ↗ Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus Completed Eli Lilly and Company Phase 2 2003-09-01 The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
NCT00085969 ↗ Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus Completed AstraZeneca Phase 2 2003-09-01 The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Exenatide

Condition Name

Condition Name for Exenatide
Intervention Trials
Type 2 Diabetes Mellitus 65
Type 2 Diabetes 46
Diabetes Mellitus, Type 2 34
Obesity 27
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Condition MeSH

Condition MeSH for Exenatide
Intervention Trials
Diabetes Mellitus 161
Diabetes Mellitus, Type 2 148
Diabetes Mellitus, Type 1 18
Obesity 15
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Clinical Trial Locations for Exenatide

Trials by Country

Trials by Country for Exenatide
Location Trials
United States 913
Canada 54
China 43
Mexico 35
United Kingdom 29
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Trials by US State

Trials by US State for Exenatide
Location Trials
Texas 59
California 48
Florida 42
New York 35
Washington 33
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Clinical Trial Progress for Exenatide

Clinical Trial Phase

Clinical Trial Phase for Exenatide
Clinical Trial Phase Trials
Phase 4 89
Phase 3 67
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Exenatide
Clinical Trial Phase Trials
Completed 206
Unknown status 28
Recruiting 21
[disabled in preview] 34
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Clinical Trial Sponsors for Exenatide

Sponsor Name

Sponsor Name for Exenatide
Sponsor Trials
AstraZeneca 80
Eli Lilly and Company 74
Amylin Pharmaceuticals, LLC. 20
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Sponsor Type

Sponsor Type for Exenatide
Sponsor Trials
Other 302
Industry 230
NIH 20
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