Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGMEDI0382 mid dose
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGPlacebo
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGLiraglutide
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
MedImmune LLC
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The study will be conducted in a double-blind fashion for MEDI0382 and placebo. The sponsor staff, the subjects, and the Investigators involved in the treatment of subjects or in the clinical evaluation of subjects will not be aware of the treatment received. Liraglutide will be provided in an open-label active comparator arm.
Intervention model description
Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Male and female subjects aged ≥ 18 years at screening * Body mass index ≥ 25 kg/m2 at screening * HbA1c range of 7.0% to 10.5% (inclusive) at screening * Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable * Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP
Exclusion criteria
* History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures * Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening * Severe allergy/hypersensitivity to any of the proposed study treatments or excipients * Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening * Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening * Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract * Significant hepatic disease * Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening * Severely uncontrolled hypertension * Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening * Severe congestive heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From baseline to 14 weeks | To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo |
| Percent Change in Body Weight | From baseline to 14 weeks | To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Body Weight | from baseline to 26 weeks and 54 weeks | To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo |
| Absolute Change in Body Weight | from baseline to 14 weeks, 26 weeks and 54 weeks | To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo |
| Percent Change in Body Weight Versus Active Comparator | from baseline to 14 weeks, 26 weeks and 54 weeks | To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily |
| Absolute Change in Body Weight Versus Active Comparator | from baseline to 14 weeks, 26 weeks and 54 weeks | To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily |
| Change in HbA1c | from baseline to 26 weeks and 54 weeks | To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo |
| Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | at 14 weeks, 26 weeks and 54 weeks | To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo |
| Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54 | To characterise the PK profile of 100, 200, and 300 μg of cotadutide |
| Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | Baseline through 54-week treatment period and 28-day follow-up | To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide |
| Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | Baseline through 54-week treatment period and 28-day follow-up | To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide |
| Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | after 14 weeks, 26 weeks and 54 weeks | To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo |
| Percentage of Participants Achieving an HbA1c Target < 7.0% | after 14, 26, and 54 weeks | To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of \<7% versus placebo |
Countries
Bulgaria, Canada, Czechia, Germany, Mexico, Russia, Slovakia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 112 |
| Liraglutide Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 110 |
| MEDI0382 100 mcg MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 100 |
| MEDI0382 200 mcg MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 256 |
| MEDI0382 300 mcg MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 256 |
| Total | 834 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 4 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 | 2 | 0 |
| Overall Study | Other reasons | 0 | 1 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 | 5 | 7 |
Baseline characteristics
| Characteristic | MEDI0382 100 mcg | MEDI0382 200 mcg | MEDI0382 300 mcg | Total | Placebo | Liraglutide |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.6 Years STANDARD_DEVIATION 9.9 | 57.3 Years STANDARD_DEVIATION 9.9 | 56.3 Years STANDARD_DEVIATION 10.2 | 56.8 Years STANDARD_DEVIATION 9.9 | 57.3 Years STANDARD_DEVIATION 9.5 | 55.5 Years STANDARD_DEVIATION 9.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 5 Participants | 0 Participants | 11 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 3 Participants | 1 Participants | 6 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 3 Participants | 10 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 99 Participants | 245 Participants | 252 Participants | 806 Participants | 107 Participants | 103 Participants |
| Sex: Female, Male Female | 57 Participants | 147 Participants | 129 Participants | 448 Participants | 55 Participants | 60 Participants |
| Sex: Female, Male Male | 43 Participants | 109 Participants | 127 Participants | 386 Participants | 57 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 110 | 0 / 100 | 2 / 256 | 1 / 256 |
| other Total, other adverse events | 45 / 112 | 36 / 110 | 51 / 100 | 159 / 256 | 164 / 256 |
| serious Total, serious adverse events | 12 / 112 | 8 / 110 | 12 / 100 | 33 / 256 | 20 / 256 |
Outcome results
Primary
Change in HbA1c
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Time frame: From baseline to 14 weeks
Population: ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change in HbA1c | -0.18 percentage |
| MEDI0382 100 mcg | Change in HbA1c | -1.01 percentage |
| MEDI0382 200 mcg | Change in HbA1c | -1.22 percentage |
| MEDI0382 300 mcg | Change in HbA1c | -1.09 percentage |
p-value: <0.00195% CI: [-1.06, -0.59]ANCOVA
p-value: <0.00195% CI: [-1.23, -0.85]ANCOVA
p-value: <0.00195% CI: [-1.11, -0.72]ANCOVA
Primary
Percent Change in Body Weight
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Time frame: From baseline to 14 weeks
Population: ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change in Body Weight | -0.70 percentage |
| MEDI0382 100 mcg | Percent Change in Body Weight | -2.70 percentage |
| MEDI0382 200 mcg | Percent Change in Body Weight | -3.47 percentage |
| MEDI0382 300 mcg | Percent Change in Body Weight | -4.33 percentage |
p-value: <0.00195% CI: [-3.08, -0.91]ANCOVA
p-value: <0.00195% CI: [-3.65, -1.87]ANCOVA
p-value: <0.00195% CI: [-4.51, -2.73]ANCOVA
Secondary
Absolute Change in Body Weight
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Absolute Change in Body Weight | from baseline to 14 weeks | -0.71 kg |
| Placebo | Absolute Change in Body Weight | from baseline to 54 weeks | -0.94 kg |
| Placebo | Absolute Change in Body Weight | from baseline to 26 weeks | -1.20 kg |
| MEDI0382 100 mcg | Absolute Change in Body Weight | from baseline to 14 weeks | -2.66 kg |
| MEDI0382 100 mcg | Absolute Change in Body Weight | from baseline to 54 weeks | -3.20 kg |
| MEDI0382 100 mcg | Absolute Change in Body Weight | from baseline to 26 weeks | -3.20 kg |
| MEDI0382 200 mcg | Absolute Change in Body Weight | from baseline to 26 weeks | -3.94 kg |
| MEDI0382 200 mcg | Absolute Change in Body Weight | from baseline to 14 weeks | -3.45 kg |
| MEDI0382 200 mcg | Absolute Change in Body Weight | from baseline to 54 weeks | -3.09 kg |
| MEDI0382 300 mcg | Absolute Change in Body Weight | from baseline to 14 weeks | -4.42 kg |
| MEDI0382 300 mcg | Absolute Change in Body Weight | from baseline to 54 weeks | -4.35 kg |
| MEDI0382 300 mcg | Absolute Change in Body Weight | from baseline to 26 weeks | -4.75 kg |
Comparison: Week 14p-value: <0.00195% CI: [-3.03, -0.87]ANCOVA
Comparison: Week 14p-value: <0.00195% CI: [-3.63, -1.86]ANCOVA
Comparison: Week 14p-value: <0.00195% CI: [-4.6, -2.82]ANCOVA
Comparison: Week 26p-value: 0.00295% CI: [-3.27, -0.74]ANCOVA
Comparison: Week 26p-value: <0.00195% CI: [-3.78, -1.71]ANCOVA
Comparison: Week 26p-value: <0.00195% CI: [-4.59, -2.52]ANCOVA
Comparison: Week 54p-value: 0.00395% CI: [-3.74, -0.79]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-3.37, -0.95]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-4.63, -2.2]ANCOVA
Secondary
Absolute Change in Body Weight Versus Active Comparator
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 14 weeks | -3.25 kg |
| Placebo | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 54 weeks | -2.94 kg |
| Placebo | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 26 weeks | -3.90 kg |
| MEDI0382 100 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 14 weeks | -2.66 kg |
| MEDI0382 100 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 54 weeks | -3.20 kg |
| MEDI0382 100 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 26 weeks | -3.20 kg |
| MEDI0382 200 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 54 weeks | -3.09 kg |
| MEDI0382 200 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 26 weeks | -3.94 kg |
| MEDI0382 200 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 14 weeks | -3.45 kg |
| MEDI0382 300 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 54 weeks | -4.35 kg |
| MEDI0382 300 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 14 weeks | -4.42 kg |
| MEDI0382 300 mcg | Absolute Change in Body Weight Versus Active Comparator | Absolute change at 26 weeks | -4.75 kg |
Comparison: Absolute change at Week 14p-value: 0.28495% CI: [-0.49, 1.68]ANCOVA
Comparison: Absolute change at Week 14p-value: 0.65895% CI: [-1.09, 0.69]ANCOVA
Comparison: Absolute change at Week 14p-value: 0.0195% CI: [-2.06, -0.27]ANCOVA
Comparison: Absolute change at Week 26p-value: 0.27995% CI: [-0.57, 1.97]ANCOVA
Comparison: Absolute change at Week 26p-value: 0.9495% CI: [-1.08, 1]ANCOVA
Comparison: Absolute change at Week 26p-value: 0.1195% CI: [-1.89, 0.19]ANCOVA
Comparison: Absolute change at Week 54p-value: 0.7395% CI: [-1.74, 1.22]ANCOVA
Comparison: Absolute change at Week 54p-value: 0.80495% CI: [-1.38, 1.07]ANCOVA
Comparison: Absolute change at Week 54p-value: 0.02395% CI: [-2.63, -0.19]ANCOVA
Secondary
Change in HbA1c
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Time frame: from baseline to 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change in HbA1c | from baseline to 26 weeks | -0.40 percentage |
| Placebo | Change in HbA1c | from baseline to 54 weeks | -0.44 percentage |
| MEDI0382 100 mcg | Change in HbA1c | from baseline to 54 weeks | -0.96 percentage |
| MEDI0382 100 mcg | Change in HbA1c | from baseline to 26 weeks | -1.06 percentage |
| MEDI0382 200 mcg | Change in HbA1c | from baseline to 26 weeks | -1.22 percentage |
| MEDI0382 200 mcg | Change in HbA1c | from baseline to 54 weeks | -1.06 percentage |
| MEDI0382 300 mcg | Change in HbA1c | from baseline to 26 weeks | -1.12 percentage |
| MEDI0382 300 mcg | Change in HbA1c | from baseline to 54 weeks | -1.01 percentage |
Comparison: Week 26p-value: <0.00195% CI: [-0.92, -0.4]ANCOVA
Comparison: Week 26p-value: <0.00195% CI: [-1.03, -0.6]ANCOVA
Comparison: Week 26p-value: <0.00195% CI: [-0.94, -0.51]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-0.8, -0.24]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-0.86, -0.39]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-0.8, -0.34]ANCOVA
Secondary
Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Time frame: Baseline through 54-week treatment period and 28-day follow-up
Population: As-treated population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive at baseline, median titer | 5.0 titer |
| Placebo | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive post-baseline, median of max. titer | 5.0 titer |
| Placebo | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA incidence, median of maximum titer | 5.0 titer |
| MEDI0382 100 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive at baseline, median titer | 5.0 titer |
| MEDI0382 100 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive post-baseline, median of max. titer | 20.0 titer |
| MEDI0382 100 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA incidence, median of maximum titer | 20.0 titer |
| MEDI0382 200 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA incidence, median of maximum titer | 20.0 titer |
| MEDI0382 200 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive at baseline, median titer | 0 titer |
| MEDI0382 200 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive post-baseline, median of max. titer | 20.0 titer |
| MEDI0382 300 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive at baseline, median titer | 0 titer |
| MEDI0382 300 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA positive post-baseline, median of max. titer | 20.0 titer |
| MEDI0382 300 mcg | Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants | ADA incidence, median of maximum titer | 20.0 titer |
Secondary
Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Time frame: Baseline through 54-week treatment period and 28-day follow-up
Population: As-treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive at baseline | 1 Participants |
| Placebo | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive post-baseline | 3 Participants |
| Placebo | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA incidence | 3 Participants |
| MEDI0382 100 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive at baseline | 1 Participants |
| MEDI0382 100 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive post-baseline | 54 Participants |
| MEDI0382 100 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA incidence | 55 Participants |
| MEDI0382 200 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA incidence | 152 Participants |
| MEDI0382 200 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive at baseline | 0 Participants |
| MEDI0382 200 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive post-baseline | 152 Participants |
| MEDI0382 300 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive at baseline | 0 Participants |
| MEDI0382 300 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA positive post-baseline | 155 Participants |
| MEDI0382 300 mcg | Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) | ADA incidence | 155 Participants |
Secondary
Percentage of Participants Achieving an HbA1c Target < 7.0%
To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of \<7% versus placebo
Time frame: after 14, 26, and 54 weeks
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 14 weeks | 19 Participants |
| Placebo | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 54 weeks | 23 Participants |
| Placebo | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 26 weeks | 25 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 14 weeks | 50 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 54 weeks | 52 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 26 weeks | 48 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 26 weeks | 139 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 14 weeks | 143 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 54 weeks | 125 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 14 weeks | 143 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 54 weeks | 128 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving an HbA1c Target < 7.0% | after 26 weeks | 143 Participants |
Comparison: Week 14p-value: <0.00192% CI: [3.34, 13.3]Regression, Logistic
Comparison: Week 14p-value: <0.00195% CI: [5.39, 18.36]Regression, Logistic
Comparison: Week 14p-value: <0.00195% CI: [4.65, 15.61]Regression, Logistic
Comparison: Week 26p-value: <0.00195% CI: [1.98, 7.03]Regression, Logistic
Comparison: Week 26p-value: <0.00195% CI: [3.13, 9.34]Regression, Logistic
Comparison: Week 26p-value: <0.00195% CI: [3.02, 8.97]Regression, Logistic
Comparison: Week 54p-value: <0.00195% CI: [2.61, 9.36]Regression, Logistic
Comparison: Week 54p-value: <0.00195% CI: [2.62, 7.89]Regression, Logistic
Comparison: Week 54p-value: <0.00195% CI: [2.51, 7.51]Regression, Logistic
Secondary
Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%
To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo
Time frame: after 14 weeks, 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 14 (LOCF) | 3 Participants |
| Placebo | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 26 (LOCF) | 11 Participants |
| Placebo | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 54 (LOCF) | 14 Participants |
| Placebo | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 14 (LOCF) | 0 Participants |
| Placebo | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 26 (LOCF) | 1 Participants |
| Placebo | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 54 (LOCF) | 2 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 54 (LOCF) | 11 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 14 (LOCF) | 6 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 14 (LOCF) | 18 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 54 (LOCF) | 34 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 26 (LOCF) | 28 Participants |
| MEDI0382 100 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 26 (LOCF) | 7 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 26 (LOCF) | 76 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 54 (LOCF) | 71 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 14 (LOCF) | 15 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 54 (LOCF) | 21 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 26 (LOCF) | 28 Participants |
| MEDI0382 200 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 14 (LOCF) | 65 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 26 (LOCF) | 27 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 54 (LOCF) | 32 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 26 (LOCF) | 110 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥10% at Wk 14 (LOCF) | 20 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 14 (LOCF) | 92 Participants |
| MEDI0382 300 mcg | Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% | Participants with weight loss ≥5% at Wk 54 (LOCF) | 98 Participants |
Comparison: weight loss \>=5% at Week 14p-value: <0.00195% CI: [2.38, 29.43]Regression, Logistic
Comparison: weight loss \>=5% at Week 14p-value: <0.00195% CI: [3.82, 40.64]Regression, Logistic
Comparison: weight loss \>=5% at Week 14p-value: <0.00195% CI: [6.55, 68.97]Regression, Logistic
Comparison: weight loss \>=5% at Week 26p-value: <0.00195% CI: [1.72, 7.89]Regression, Logistic
Comparison: weight loss \>=5% at Week 26p-value: <0.00195% CI: [2, 7.78]Regression, Logistic
Comparison: weight loss \>=5% at Week 26p-value: <0.00195% CI: [3.72, 14.24]Regression, Logistic
Comparison: weight loss \>=5% at Week 54p-value: <0.00195% CI: [1.84, 7.45]Regression, Logistic
Comparison: weight loss \>=5% at Week 54p-value: 0.00295% CI: [1.46, 5.09]Regression, Logistic
Comparison: weight loss \>=5% at Week 54p-value: <0.00195% CI: [2.42, 8.3]ANCOVA
Comparison: weight loss \>=10% at Week 26p-value: 0.04895% CI: [1.02, 70.17]Regression, Logistic
Comparison: weight loss \>=10% at Week 26p-value: 0.0195% CI: [1.85, 102.91]Regression, Logistic
Comparison: weight loss \>=10% at Week 26p-value: 0.01295% CI: [1.75, 97.68]Regression, Logistic
Comparison: weight loss \>=10% at Week 54p-value: 0.01395% CI: [1.49, 32.07]Regression, Logistic
Comparison: weight loss \>=10% at Week 54p-value: 0.03295% CI: [1.15, 21.6]Regression, Logistic
Comparison: weight loss \>=10% at Week 54p-value: 0.00595% CI: [1.86, 33.64]Regression, Logistic
Secondary
Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control
To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo
Time frame: at 14 weeks, 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 14 wks | 11 Participants |
| Placebo | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 14 wks | 2 Participants |
| Placebo | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 54 wks | 34 Participants |
| Placebo | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 54 wks | 4 Participants |
| Placebo | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 26 wks | 4 Participants |
| Placebo | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 26 wks | 20 Participants |
| MEDI0382 100 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 54 wks | 10 Participants |
| MEDI0382 100 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 14 wks | 1 Participants |
| MEDI0382 100 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 26 wks | 3 Participants |
| MEDI0382 100 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 14 wks | 0 Participants |
| MEDI0382 100 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 26 wks | 1 Participants |
| MEDI0382 100 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 54 wks | 1 Participants |
| MEDI0382 200 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 26 wks | 8 Participants |
| MEDI0382 200 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 14 wks | 1 Participants |
| MEDI0382 200 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 54 wks | 3 Participants |
| MEDI0382 200 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 26 wks | 2 Participants |
| MEDI0382 200 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 14 wks | 3 Participants |
| MEDI0382 200 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 54 wks | 26 Participants |
| MEDI0382 300 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 26 wks | 6 Participants |
| MEDI0382 300 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 54 wks | 0 Participants |
| MEDI0382 300 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 26 wks | 0 Participants |
| MEDI0382 300 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | discontinued study IP at 14 wks | 0 Participants |
| MEDI0382 300 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 14 wks | 2 Participants |
| MEDI0382 300 mcg | Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control | received rescue medication at 54 wks | 24 Participants |
Comparison: received rescue medication at 14 wksp-value: 0.02495% CI: [0.01, 0.73]Regression, Logistic
Comparison: received rescue medication at 14 wksp-value: <0.00195% CI: [0.03, 0.4]Regression, Logistic
Comparison: received rescue medication at 14 wksp-value: <0.00195% CI: [0.02, 0.33]Regression, Logistic
Comparison: received rescue medication at 26 wksp-value: 0.00295% CI: [0.04, 0.48]Regression, Logistic
Comparison: received rescue medication at 26 wksp-value: <0.00195% CI: [0.06, 0.34]Regression, Logistic
Comparison: received rescue medication at 26 wksp-value: <0.00195% CI: [0.04, 0.28]Regression, Logistic
Comparison: received rescue medication at 54 wksp-value: <0.00195% CI: [0.11, 0.53]Regression, Logistic
Comparison: received rescue medication at 54 wksp-value: <0.00195% CI: [0.13, 0.44]Regression, Logistic
Comparison: received rescue medication at 54 wksp-value: <0.00195% CI: [0.12, 0.41]Regression, Logistic
Comparison: discontinued IP at 14 wksp-value: 0.21695% CI: [0.02, 2.43]Regression, Logistic
Comparison: discontinued IP at 26 wksp-value: 0.25395% CI: [0.03, 2.52]Regression, Logistic
Comparison: discontinued IP at 26 wksp-value: 0.07995% CI: [0.04, 1.19]Regression, Logistic
Comparison: discontinued IP at 54 wksp-value: 0.25295% CI: [0.03, 2.5]Regression, Logistic
Comparison: discontinued IP at 54 wksp-value: 0.14395% CI: [0.07, 1.47]Regression, Logistic
Secondary
Percent Change in Body Weight
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo
Time frame: from baseline to 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change in Body Weight | from baseline to 54 weeks | -0.84 percentage |
| Placebo | Percent Change in Body Weight | from baseline to 26 weeks | -1.14 percentage |
| MEDI0382 100 mcg | Percent Change in Body Weight | from baseline to 26 weeks | -3.23 percentage |
| MEDI0382 100 mcg | Percent Change in Body Weight | from baseline to 54 weeks | -3.27 percentage |
| MEDI0382 200 mcg | Percent Change in Body Weight | from baseline to 54 weeks | -3.08 percentage |
| MEDI0382 200 mcg | Percent Change in Body Weight | from baseline to 26 weeks | -3.94 percentage |
| MEDI0382 300 mcg | Percent Change in Body Weight | from baseline to 54 weeks | -4.16 percentage |
| MEDI0382 300 mcg | Percent Change in Body Weight | from baseline to 26 weeks | -4.60 percentage |
Comparison: Week 26p-value: <0.00195% CI: [-3.32, -0.85]ANCOVA
Comparison: Week 26p-value: <0.00195% CI: [-3.82, -1.79]ANCOVA
Comparison: Week 26p-value: <0.00195% CI: [-4.48, -2.44]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-3.86, -1]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-3.41, -1.06]ANCOVA
Comparison: Week 54p-value: <0.00195% CI: [-4.49, -2.14]ANCOVA
Secondary
Percent Change in Body Weight Versus Active Comparator
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
Population: ITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change in Body Weight Versus Active Comparator | Percent change at 14 weeks | -3.40 percentage |
| Placebo | Percent Change in Body Weight Versus Active Comparator | Percent change at 54 weeks | -3.20 percentage |
| Placebo | Percent Change in Body Weight Versus Active Comparator | Percent change at 26 weeks | -4.12 percentage |
| MEDI0382 100 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 14 weeks | -2.70 percentage |
| MEDI0382 100 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 54 weeks | -3.27 percentage |
| MEDI0382 100 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 26 weeks | -3.23 percentage |
| MEDI0382 200 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 26 weeks | -3.94 percentage |
| MEDI0382 200 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 14 weeks | -3.47 percentage |
| MEDI0382 200 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 54 weeks | -3.08 percentage |
| MEDI0382 300 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 14 weeks | -4.33 percentage |
| MEDI0382 300 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 54 weeks | -4.16 percentage |
| MEDI0382 300 mcg | Percent Change in Body Weight Versus Active Comparator | Percent change at 26 weeks | -4.60 percentage |
Comparison: Percent change at Week 14p-value: 0.21195% CI: [-0.39, 1.79]ANCOVA
Comparison: Percent change at Week 14p-value: 0.88195% CI: [-0.96, 0.83]ANCOVA
Comparison: Percent change at Week 14p-value: 0.04295% CI: [-1.82, -0.04]ANCOVA
Comparison: Percent change at Week 26p-value: 0.15895% CI: [-0.35, 2.14]ANCOVA
Comparison: Percent change at Week 26p-value: 0.73495% CI: [-0.85, 1.2]ANCOVA
Comparison: Percent change at Week 26p-value: 0.35795% CI: [-1.51, 0.54]ANCOVA
Comparison: Percent change at Week 54p-value: 0.92195% CI: [-1.51, 1.37]ANCOVA
Comparison: Percent change at Week 54p-value: 0.84795% CI: [-1.07, 1.3]ANCOVA
Comparison: Percent change at Week 54p-value: 0.11295% CI: [-2.15, 0.22]ANCOVA
Secondary
Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)
To characterise the PK profile of 100, 200, and 300 μg of cotadutide
Time frame: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 10 | 3.18 ng/mL | Standard Deviation 2.26 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 54 | 4.58 ng/mL | Standard Deviation 3.89 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 18 | 4.58 ng/mL | Standard Deviation 5.04 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 14 | 3.79 ng/mL | Standard Deviation 4.05 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 1 | 2.68 ng/mL | Standard Deviation 1.27 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 26 | 4.39 ng/mL | Standard Deviation 3.33 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 6 | 2.75 ng/mL | Standard Deviation 1.44 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 2 | 2.66 ng/mL | Standard Deviation 1.61 |
| MEDI0382 100 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 22 | 4.63 ng/mL | Standard Deviation 4.28 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 14 | 6.50 ng/mL | Standard Deviation 5.26 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 1 | 2.76 ng/mL | Standard Deviation 1.88 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 2 | 5.13 ng/mL | Standard Deviation 3.23 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 6 | 5.20 ng/mL | Standard Deviation 3.57 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 10 | 5.74 ng/mL | Standard Deviation 4.23 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 18 | 7.43 ng/mL | Standard Deviation 6.43 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 22 | 8.07 ng/mL | Standard Deviation 7.01 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 26 | 8.12 ng/mL | Standard Deviation 7.31 |
| MEDI0382 200 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 54 | 8.99 ng/mL | Standard Deviation 9.22 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 6 | 7.77 ng/mL | Standard Deviation 4.88 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 1 | 2.77 ng/mL | Standard Deviation 1.84 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 22 | 11.5 ng/mL | Standard Deviation 9.77 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 2 | 5.18 ng/mL | Standard Deviation 3.05 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 54 | 13.2 ng/mL | Standard Deviation 14.3 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 14 | 9.71 ng/mL | Standard Deviation 7.64 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 10 | 8.23 ng/mL | Standard Deviation 4.31 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 26 | 12.9 ng/mL | Standard Deviation 12.1 |
| MEDI0382 300 mcg | Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) | Week 18 | 10.8 ng/mL | Standard Deviation 7.95 |