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Exenatide LAR

Phase 4

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Feb 24, 2015

Exenatide LAR development status

Highest phase Phase 4 (NCT03002675)
Phase scored for AZNPhase 2
Registered trials 4 across 2 sponsors since Feb 2005

Exenatide LAR target and mechanism

Molecular targetGLP1R
Target classAgonist
ModalitySmall molecule

Also known as Bydureon

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Exenatide LAR clinical trials

Exenatide LAR · 1 trial · 1 indication

Phase 2 1
NCT00103935Study Examining Exenatide Long-Acting Release in Subjects With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED45 Analytics
PHASE2COMPLETED
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)
Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours

Secondary Endpoints

Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus
Various time intervals from Day 1 to Week 15
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A1PLACEBO_COMPARATORPlacebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
Group A2PLACEBO_COMPARATORPlacebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
Group BEXPERIMENTALExenatide lead-in followed by exenatide LAR 0.8 mg weekly
Group CEXPERIMENTALExenatide lead-in followed by exenatide LAR 2.0 mg weekly

Interventions

NameTypeDescription
placeboDRUGSubcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Exenatide LARDRUGSubcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months. * Has HbA1c of 7.1% to 11.0%, inclusive. * Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. Ex...

Countries:United States
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Frequently asked questions about Exenatide LAR

What is Exenatide LAR used for?

Exenatide LAR is an investigational therapy being studied for the treatment of Type 2 Diabetes Mellitus. It is designed as a long-acting formulation intended to provide extended glucose-lowering activity in adults with this metabolic condition. It has been evaluated in a Phase 2 clinical trial in the United States.

What does Exenatide LAR target?

Exenatide LAR targets GLP1R, the glucagon-like peptide-1 receptor, and acts as a receptor agonist. By activating GLP1R, the drug is designed to mimic the action of the endogenous incretin hormone GLP-1, which supports glucose-dependent insulin regulation in patients with Type 2 Diabetes Mellitus.

Who is developing Exenatide LAR?

Exenatide LAR is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is responsible for advancing this long-acting GLP1R agonist candidate for Type 2 Diabetes Mellitus through clinical development.

What phase is Exenatide LAR in?

Exenatide LAR is in Phase 2 clinical development for Type 2 Diabetes Mellitus. It is an investigational agent and is not approved for commercial use. The Phase 2 program has completed, and no active trials are currently listed for this asset.

What clinical trials is Exenatide LAR in?

Exenatide LAR has been evaluated in one completed Phase 2 trial, NCT00103935, titled "Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes." The trial enrolled 45 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.