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AZD4017

Phase 2

Raised Intraocular Pressure | Small molecule | Ophthalmology |AstraZeneca PLC|Trials Updated: Feb 14, 2014

AZD4017 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Nov 2008

AZD4017 target and mechanism

Molecular targetHSD11B1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment172

FDA Designations

No designations recorded

AZD4017 clinical trials

AZD4017 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT01173471A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular PressureRaised Intraocular Pressure
COMPLETED50 Analytics
PHASE2COMPLETED
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Raised Intraocular PressureUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Baseline to 4 weeks
To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation
A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
The variables will be measured predose and then repeatedly during the study

Secondary Endpoints

Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
Baseline to 4 weeks
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Baseline to 4 weeks
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
The variables will be measure predose and the repeatedly during the following 10 days after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1) AZD4017EXPERIMENTALEurope: 200 mg AZD4017
2) PlaceboPLACEBO_COMPARATOREurope: placebo
3) AZD4017EXPERIMENTALUSA: 800 mg AZD4017
4) PlaceboPLACEBO_COMPARATORUSA: placebo
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD4017DRUGtablet, oral, one tablet once daily, 28 days
PlaceboDRUGmatching placebo tablet, oral, one tablet once daily, 28 days
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP \>20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the scr...

Countries:United StatesSwedenUnited Kingdom
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Frequently asked questions about AZD4017

What is AZD4017?

AZD4017 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in clinical trials for type 2 diabetes mellitus, obesity, and raised intraocular pressure. It is not yet approved and remains in clinical development.

What is AZD4017 used for?

AZD4017 has been evaluated in clinical trials for type 2 diabetes mellitus, obesity, and raised intraocular pressure. These studies were conducted in the United States, Sweden, and the United Kingdom. It is an investigational agent and is not approved for any indication.

What does AZD4017 target?

AZD4017 targets HSD11B1 (11 beta hydroxysteroid dehydrogenase type 1). It acts as an inhibitor of this enzyme. This target is relevant to metabolic conditions such as type 2 diabetes and obesity, as well as raised intraocular pressure.

Who makes AZD4017?

AZD4017 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating AZD4017 in metabolic and ocular conditions.

What phase is AZD4017 in?

AZD4017 has completed Phase 1 and Phase 2a clinical trials. The Phase 1 studies enrolled healthy volunteers, while the Phase 2a study evaluated the drug in patients with raised intraocular pressure. It is not approved and remains investigational.

What clinical trials is AZD4017 in?

AZD4017 has been studied in three completed trials: NCT01173471, a Phase 2a study in raised intraocular pressure; NCT01096004, a Phase 1 study in obesity; and NCT00841048, a Phase 1 study in type 2 diabetes. All trials are completed.