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A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).
This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI-4166 | Experimental | MEDI-4166 administered subcutaneously |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-4166 | Biological | MEDI-4166 administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) | 43 days post dosing |
| Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | 12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals | 43 days post dosing |
| Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate) | 43 days post dosing |
| Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Clinical laboratory assessments (serum chemistry, hematology, urinalysis) | 43 days post dosing |
| Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Physical examination | 43 days post dosing |
| Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) | Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) | 43 days post dosing |
| Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anniston | Alabama | 36207 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30593607 | Derived | Jain M, Carlson G, Cook W, Morrow L, Petrone M, White NE, Wang T, Naylor J, Ambery P, Lee C, Hirshberg B. Randomised, phase 1, dose-finding study of MEDI4166, a PCSK9 antibody and GLP-1 analogue fusion molecule, in overweight or obese patients with type 2 diabetes mellitus. Diabetologia. 2019 Mar;62(3):373-386. doi: 10.1007/s00125-018-4789-6. Epub 2018 Dec 28. |
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| Placebo |
| Biological |
Placebo administered subcutaneously |
|
Part B: Change in LDL-C from baseline to Day 36
| 36 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 | Part A: Change from baseline in LDL-C | 43 days post dosing |
| Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166 | Part A: Proportion of subjects with ADA to MEDI4166 | 43 days post dosing |
| Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) | 71 days post dosing |
| Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | 12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals | 71 days post dosing |
| Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate) | 71 days post dosing |
| Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Clinical laboratory assessments (serum chemistry, hematology, urinalysis) | 71 days post dosing |
| Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | Physical examination | 71 days post dosing |
| Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) | Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) | 71 days post dosing |
| Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) | Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) | 71 days post dosing |
| Part B: Change from baseline in fructosamine levels | Part B: Change from baseline in fructosamine levels | 36 days post dosing |
| Part B: Proportion of subjects with ADA to MEDI4166 | Part B: Proportion of subjects with ADA to MEDI4166 | 71 days post dosing |
| Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) | Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) | 43 days post dosing |
| Part A: Change from baseline in glucose AUC up to 240 minutes | Part A: Change from baseline in glucose AUC up to 240 minutes | 43 days post dosing |
| Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) | Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) | 71 days post dosing |
| Chula Vista |
| California |
| 91911 |
| United States |
| Research Site | Jacksonville | Florida | 32216 | United States |
| Research Site | Miami | Florida | 33014 | United States |
| Research Site | South Miami | Florida | 33143 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Cincinnati | Ohio | 45227 | United States |
| Research Site | Knoxville | Tennessee | 37920 | United States |
| Research Site | San Antonio | Texas | 78209 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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