Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-4166 · 1 trial · 1 indication
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
| Arm | Type | Description |
|---|---|---|
| MEDI-4166 | EXPERIMENTAL | MEDI-4166 administered subcutaneously |
| Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously |
| Name | Type | Description |
|---|---|---|
| MEDI-4166 | BIOLOGICAL | MEDI-4166 administered subcutaneously |
| Placebo | BIOLOGICAL | Placebo administered subcutaneously |
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...
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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.
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.
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.
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.
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.