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MEDI-4166

Phase 1

Type 2 Diabetes | Monoclonal antibody | Metabolic |AstraZeneca PLC|Last Updated: Mar 13, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-4166 · 1 trial · 1 indication

Phase 1 1
NCT02524782A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 DiabetesType 2 Diabetes
COMPLETED103 Analytics
PHASE1COMPLETED
A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
43 days post dosing

Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36
36 days post dosing
Part B: Change in LDL-C from baseline to Day 36
36 days post dosing

Secondary Endpoints

Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
43 days post dosing
Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
43 days post dosing
Part A: Change from baseline in LDL-C
43 days post dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI-4166EXPERIMENTALMEDI-4166 administered subcutaneously
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously

Interventions

NameTypeDescription
MEDI-4166BIOLOGICALMEDI-4166 administered subcutaneously
PlaceboBIOLOGICALPlacebo administered subcutaneously
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Type 2 Diabetes, ages 18-65 * Must provide written informed consent * BMI\>=25 and =\<42 * Venous access suitable for multiple cannulations * Vital signs within normal specified ranges * Females must be non-lactating and non-childbearing potential * Males must practice 2 effec...

Countries:United States
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Frequently asked questions about MEDI-4166

What is MEDI-4166 used for?

MEDI-4166 is an investigational monoclonal antibody being developed for the treatment of Type 2 Diabetes. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Type 2 Diabetes.

Who makes MEDI-4166?

MEDI-4166 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Type 2 Diabetes.

What phase is MEDI-4166 in?

MEDI-4166 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for Type 2 Diabetes.

What clinical trials is MEDI-4166 in?

MEDI-4166 has one completed Phase 1 clinical trial with the identifier NCT02524782. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of MEDI-4166 in 103 participants with Type 2 Diabetes. The trial was randomized, double-blind, and placebo-controlled, and was conducted in the United States.

Is MEDI-4166 FDA approved?

MEDI-4166 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes. The completed Phase 1 trial focused on safety and tolerability, and further clinical studies would be needed before any regulatory approval could be considered.