← Trials/Trial dossier/NCT03745937
A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MEDI0382 in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
Lead sponsor
Asset
Cotadutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
—
Enrollment
20
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI 27-35•HbA1c 6.5-8.5%
Primary endpoints
•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Treatment-emergent AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Participants aged 18 to 74 years (inclusive) at screening.
2. Provision of signed and dated written informed consent (with the exception of consent for genetic and non-genetic research) prior to any study specific procedures.
3. Body mass index (BMI) between 27 and 35 kg/m^2 (inclusive) at screening.
4. Hemoglobin A1c (HbA1c) range of 6.5% to 8.5% (inclusive) at screening (Note: Participants may be re-tested for the HbA1c entry criterion only once.).
5. Willing and able to self-inject study drug for the duration of the study.
6. Diagnosed with type 2 diabetes mellitus with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease >= 500 mg/day) has occurred in the three months prior to screening.
7. Female participants must have a negative pregnancy test at screening and randomization, and must not be lactating.
8. Female participants of childbearing potential who are sexually active with a male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of study drug.
Exclusion criteria
1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures during the run-in period.
2. Any participant who has received another study drug as part of a clinical study or a glucagon-like peptide-1 (GLP-1) analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
3. Concurrent participation in another study of any kind and repeat randomization in this study is prohibited.
4. Any participant who has received any of the following medications prior to the start of the study:
5. Severe allergy/hypersensitivity to any of the proposed study treatments, standardized meals, or excipients.
6. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the participant has been treated with daily SC insulin within 90 days prior to screening.
7. Acute pancreatitis, pancreatic amylase, and/or pancreatic lipase > 3 × upper limit of normal range (ULN); history of chronic pancreatitis; or serum triglyceride levels > 11 mmol/L (1000 mg/dL) at screening.
8. Significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures), which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
9. Significant hepatic disease (except for nonalcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
10. Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73m^2 at screening.
11. Poorly controlled hypertension defined as:
12. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes.
13. Prolonged QT intervals corrected for heart rate or family history of long QT-segment at screening.
14. PR (PQ) interval prolongation, intermittent second or third-degree atrioventricular (AV) block, or AV dissociation.
15. Persistent or intermittent complete bundle branch block.
16. Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening.
17. Severe congestive heart failure.
18. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
19. Hemoglobinopathy, hemolytic anemia or chronic anemia or any other condition known to interfere with the interpretation of HbA1c measurement.
20. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer.
21. Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
22. History of substance dependence, alcohol abuse, or excessive alcohol intake. Participants who use benzodiazepines for chronic anxiety or sleep disorders may be permitted to enter the study.
23. Symptoms of depression or any other psychiatric disorder requiring treatment with medication.
24. History of severe allergy/hypersensitivity, including to any component of the investigational product formulation or other biological agent, or ongoing clinically important allergy/hypersensitivity.
25. Blood/plasma donation within 1 month of screening.
Endpoints (30)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
5 endpointsAbsolute Change From Baseline in Body Weight
Time frame:Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 56 | -0.30 | — |
| Day 77 | -1.25 | — |
| MEDI0382 Cohort 1Day 56 | -5.27 | — |
| Day 77 | -6.96 | — |
| Placebo Cohort 2Day 56 | -1.70 | — |
| Day 77 | -1.50 | — |
| MEDI0382 Cohort 2Day 56 | -2.89 | — |
| Day 77 | -4.56 | — |
Percentage Change From Baseline in Body Weight
Time frame:Baseline (Day -1) through Day 56 (end of the up-titration period) and Day 77 (end of the TEP)
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change in body weight | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 56 | -0.33 | — |
| Day 77 | -1.38 | — |
| MEDI0382 Cohort 1Day 56 | -5.06 | — |
| Day 77 | -6.88 | — |
| Placebo Cohort 2Day 56 | -1.96 | — |
| Day 77 | -1.76 | — |
| MEDI0382 Cohort 2Day 56 | -3.20 | — |
| Day 77 | -5.08 | — |
Absolute Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period
Time frame:Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 7 | -2.05 | — |
| Day 14 | -1.95 | — |
| Day 35 | -0.60 | — |
| Day 42 | -0.10 | — |
| Day 49 | 0.10 | — |
| Day 56 | -0.30 | — |
| MEDI0382 Cohort 1Day 7 | -1.78 | — |
| Day 14 | -2.72 | — |
| Day 35 | -3.86 | — |
| Day 42 | -4.40 | — |
| Day 49 | -4.94 | — |
| Day 56 | -5.27 | — |
| Placebo Cohort 2Day 7 | -0.70 | — |
| Day 14 | -0.73 | — |
| Day 35 | -0.27 | — |
| Day 42 | -1.57 | — |
| Day 49 | -1.57 | — |
| Day 56 | -1.70 | — |
| MEDI0382 Cohort 2Day 7 | 0.49 | — |
| Day 14 | 0.08 | — |
| Day 35 | -1.70 | — |
| Day 42 | -2.00 | — |
| Day 49 | -3.30 | — |
| Day 56 | -2.89 | — |
Percentage Change From Baseline in Body Weight to the End of Each Week of the Up-titration Period
Time frame:Baseline (Day -1), Days 7, 14, 35, 42, 49, and 56
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change in body weight | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 7 | -2.22 | — |
| Day 14 | -2.13 | — |
| Day 35 | -0.64 | — |
| Day 42 | -0.11 | — |
| Day 49 | 0.11 | — |
| Day 56 | -0.33 | — |
| MEDI0382 Cohort 1Day 7 | -1.83 | — |
| Day 14 | -2.76 | — |
| Day 35 | -3.89 | — |
| Day 42 | -4.43 | — |
| Day 49 | -4.95 | — |
| Day 56 | -5.06 | — |
| Placebo Cohort 2Day 7 | -0.77 | — |
| Day 14 | -0.83 | — |
| Day 35 | -0.27 | — |
| Day 42 | -1.81 | — |
| Day 49 | -1.82 | — |
| Day 56 | -1.96 | — |
| MEDI0382 Cohort 2Day 7 | 0.67 | — |
| Day 14 | 0.22 | — |
| Day 35 | -1.78 | — |
| Day 42 | -2.09 | — |
| Day 49 | -3.52 | — |
| Day 56 | -3.20 | — |
Percentage of Participants Achieving Greater Than 5% Body Weight Loss From Baseline to the End of the Treatment Extension Period
Time frame:Baseline (Day -1) through Day 77 (end of the treatment extension period)
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 7 | 0 | — |
| Day 14 | 0 | — |
| Day 35 | 0 | — |
| Day 42 | 0 | — |
| Day 49 | 0 | — |
| Day 56 | 0 | — |
| Day 77 | 0 | — |
| MEDI0382 Cohort 1Day 7 | 0 | — |
| Day 14 | 0 | — |
| Day 35 | 40 | — |
| Day 42 | 40 | — |
| Day 49 | 60 | — |
| Day 56 | 50 | — |
| Day 77 | 80 | — |
| Placebo Cohort 2Day 7 | 0 | — |
| Day 14 | 0 | — |
| Day 35 | 0 | — |
| Day 42 | 0 | — |
| Day 49 | 0 | — |
| Day 56 | 0 | — |
| Day 77 | 0 | — |
| MEDI0382 Cohort 2Day 7 | 0 | — |
| Day 14 | 0 | — |
| Day 35 | 25 | — |
| Day 42 | 25 | — |
| Day 49 | 50 | — |
| Day 56 | 28.6 | — |
| Day 77 | 71.4 | — |
Glycemic / diabetes
9 endpointsChange From Baseline in Daily (24 Hours) Average Glucose Levels Over Time as Measured by Continuous Glucose Monitoring (CGM)
Time frame:Baseline (Day -1) through Day 56 (end of the up-titration period), Day 77 (end of the treatment extension period) and Day 91 (end of the follow-up period)
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 56 | -14.96 | — |
| Day 77 | -10.41 | — |
| Day 91 | -1.80 | — |
| MEDI0382 Cohort 1Day 56 | -52.04 | — |
| Day 77 | -49.24 | — |
| Day 91 | -5.71 | — |
| Placebo Cohort 2Day 56 | -22.51 | — |
| Day 77 | -32.54 | — |
| Day 91 | 20.28 | — |
| MEDI0382 Cohort 2Day 56 | -34.25 | — |
| Day 77 | -39.70 | — |
| Day 91 | -13.03 | — |
Change From Baseline in 7-day Average Glucose Levels Over Time as Measured by CGM
Time frame:Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Placebo Cohort 1Days 1-7 | 37.53 | — |
| Days 8-14 | 22.73 | — |
| Days 15-21 | 13.83 | — |
| Days 22-28 | 12.54 | — |
| Days 29-35 | 16.11 | — |
| Days 36-42 | 22.29 | — |
| Days 43-49 | 5.69 | — |
| Days 50-56 | 2.02 | — |
| Days 71-77 | 21.50 | — |
| MEDI0382 Cohort 1Days 1-7 | -34.64 | — |
| Days 8-14 | -52.07 | — |
| Days 15-21 | -44.84 | — |
| Days 22-28 | -53.38 | — |
| Days 29-35 | -63.28 | — |
| Days 36-42 | -47.97 | — |
| Days 43-49 | -48.06 | — |
| Days 50-56 | -55.21 | — |
| Days 71-77 | -62.66 | — |
| Placebo Cohort 2Days 1-7 | -3.96 | — |
| Days 8-14 | -14.44 | — |
| Days 15-21 | -13.72 | — |
| Days 22-28 | 5.88 | — |
| Days 29-35 | 0.32 | — |
| Days 36-42 | -20.03 | — |
| Days 43-49 | -19.88 | — |
| Days 50-56 | -19.59 | — |
| Days 71-77 | -19.06 | — |
| MEDI0382 Cohort 2Days 1-7 | -26.06 | — |
| Days 8-14 | -39.86 | — |
| Days 15-21 | -38.10 | — |
| Days 22-28 | -25.10 | — |
| Days 29-35 | -40.83 | — |
| Days 36-42 | -35.45 | — |
| Days 43-49 | -46.84 | — |
| Days 50-56 | -37.89 | — |
| Days 71-77 | -40.20 | — |
Percentage Change From Baseline in Glucose Area Under Concentration Time-curve Over 4 Hours (AUC4Hrs) During a Standardized Breakfast, Lunch, and Evening Meal Over Time as Measured by CGM
Time frame:Baseline (Day -1) through Day 7 (end of Week 1), Day 56 (end of the up-titration period), and Day 77 (end of the treatment extension period)
Postprandial glucose
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percent change in Glucose AUC4Hrs | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 7 - Breakfast | -3.72 | — |
| Day 56 - Breakfast | -21.96 | — |
| Day 77 - Breakfast | -10.54 | — |
| Day 7 - Lunch | -3.06 | — |
| Day 56 - Lunch | -7.35 | — |
| Day 77 - Lunch | -7.76 | — |
| Day 7 - Evening Meal | -7.81 | — |
| Day 56 - Evening Meal | -11.07 | — |
| Day 77 - Evening Meal | -12.12 | — |
| MEDI0382 Cohort 1Day 7 - Breakfast | -27.90 | — |
| Day 56 - Breakfast | -42.22 | — |
| Day 77 - Breakfast | -41.52 | — |
| Day 7 - Lunch | -32.55 | — |
| Day 56 - Lunch | -33.67 | — |
| Day 77 - Lunch | -31.10 | — |
| Day 7 - Evening Meal | -16.14 | — |
| Day 56 - Evening Meal | -35.39 | — |
| Day 77 - Evening Meal | -26.09 | — |
| Placebo Cohort 2Day 7 - Breakfast | -8.66 | — |
| Day 56 - Breakfast | -10.18 | — |
| Day 77 - Breakfast | -19.21 | — |
| Day 7 - Lunch | 0.32 | — |
| Day 56 - Lunch | -24.06 | — |
| Day 77 - Lunch | -28.75 | — |
| Day 7 - Evening Meal | -10.37 | — |
| Day 56 - Evening Meal | -22.08 | — |
| Day 77 - Evening Meal | -22.06 | — |
| MEDI0382 Cohort 2Day 7 - Breakfast | -25.85 | — |
| Day 56 - Breakfast | -32.82 | — |
| Day 77 - Breakfast | -32.48 | — |
| Day 7 - Lunch | -15.68 | — |
| Day 56 - Lunch | -18.30 | — |
| Day 77 - Lunch | -21.58 | — |
| Day 7 - Evening Meal | -22.58 | — |
| Day 56 - Evening Meal | -31.44 | — |
| Day 77 - Evening Meal | -34.18 | — |
Change From Baseline in Coefficient of Variation (CV) in Glucose Over 7 Days as Measured by CGM
Time frame:Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
change from baseline, improvement
Posted result
| Group | Value (mean), Percent of CV | 95% CI |
|---|---|---|
| Placebo Cohort 1Days 1 - 7 | -4.48 | — |
| Days 8 - 14 | -3.67 | — |
| Days 15 - 21 | -8.86 | — |
| Days 22 - 28 | -4.79 | — |
| Days 29 - 35 | -7.92 | — |
| Days 36 - 42 | 0.93 | — |
| Days 43 - 49 | -3.96 | — |
| Days 50 - 56 | -2.97 | — |
| Days 71 - 77 | -4.91 | — |
| MEDI0382 Cohort 1Days 1 - 7 | -0.96 | — |
| Days 8 - 14 | -2.97 | — |
| Days 15 - 21 | -2.65 | — |
| Days 22 - 28 | -3.70 | — |
| Days 29 - 35 | -5.84 | — |
| Days 36 - 42 | -4.96 | — |
| Days 43 - 49 | -3.68 | — |
| Days 50 - 56 | -2.94 | — |
| Days 71 - 77 | -2.15 | — |
| Placebo Cohort 2Days 1 - 7 | 1.51 | — |
| Days 8 - 14 | 2.26 | — |
| Days 15 - 21 | -1.54 | — |
| Days 22 - 28 | -2.49 | — |
| Days 29 - 35 | -3.24 | — |
| Days 36 - 42 | 1.39 | — |
| Days 43 - 49 | 2.18 | — |
| Days 50 - 56 | 4.10 | — |
| Days 71 - 77 | 2.60 | — |
| MEDI0382 Cohort 2Days 1 - 7 | -2.41 | — |
| Days 8 - 14 | -0.95 | — |
| Days 15 - 21 | -4.44 | — |
| Days 22 - 28 | -1.56 | — |
| Days 29 - 35 | -2.52 | — |
| Days 36 - 42 | -1.38 | — |
| Days 43 - 49 | -1.98 | — |
| Days 50 - 56 | -2.36 | — |
| Days 71 - 77 | -0.82 | — |
Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 24 Hours Time as Measured by CGM
Time frame:Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)
change from baseline, improvement
Posted result
| Group | Value (mean), Percentage of time spent | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 7 - Hyperglycemia | -19.79 | — |
| Day 14 - Hyperglycemia | -5.73 | — |
| Day 21 - Hyperglycemia | -3.65 | — |
| Day 28 - Hyperglycemia | -9.90 | — |
| Day 35 - Hyperglycemia | -6.01 | — |
| Day 42 - Hyperglycemia | -19.80 | — |
| Day 49 - Hyperglycemia | 9.90 | — |
| Day 56 - Hyperglycemia | -20.31 | — |
| Day 77 - Hyperglycemia | -21.35 | — |
| Day 7 - Normoglycemia | 19.27 | — |
| Day 14 - Normoglycemia | 5.21 | — |
| Day 21 - Normoglycemia | 3.13 | — |
| Day 28 - Normoglycemia | 9.90 | — |
| Day 35 - Normoglycemia | 5.48 | — |
| Day 42 - Normoglycemia | 19.79 | — |
| Day 49 - Normoglycemia | -10.42 | — |
| Day 56 - Normoglycemia | 19.79 | — |
| Day 77 - Normoglycemia | 18.75 | — |
| Day 7 - Hypoglycemia | 0.00 | — |
| Day 14 - Hypoglycemia | 0.00 | — |
| Day 21 - Hypoglycemia | 0.00 | — |
| Day 28 - Hypoglycemia | 0.00 | — |
| Day 35 - Hypoglycemia | 0.00 | — |
| Day 42 - Hypoglycemia | 0.00 | — |
| Day 49 - Hypoglycemia | 0.00 | — |
| Day 56 - Hypoglycemia | 0.00 | — |
| Day 77 - Hypoglycemia | 0.00 | — |
| MEDI0382 Cohort 1Day 7 - Hyperglycemia | -39.06 | — |
| Day 14 - Hyperglycemia | -41.67 | — |
| Day 21 - Hyperglycemia | -38.50 | — |
| Day 28 - Hyperglycemia | -33.54 | — |
| Day 35 - Hyperglycemia | -51.24 | — |
| Day 42 - Hyperglycemia | -38.33 | — |
| Day 49 - Hyperglycemia | -49.79 | — |
| Day 56 - Hyperglycemia | -50.21 | — |
| Day 77 - Hyperglycemia | -46.04 | — |
| Day 7 - Normoglycemia | 39.58 | — |
| Day 14 - Normoglycemia | 41.25 | — |
| Day 21 - Normoglycemia | 39.06 | — |
| Day 28 - Normoglycemia | 20.21 | — |
| Day 35 - Normoglycemia | 39.35 | — |
| Day 42 - Normoglycemia | 34.58 | — |
| Day 49 - Normoglycemia | 47.92 | — |
| Day 56 - Normoglycemia | 40.42 | — |
| Day 77 - Normoglycemia | 43.13 | — |
| Day 7 - Hypoglycemia | 0.00 | — |
| Day 14 - Hypoglycemia | 0.00 | — |
| Day 21 - Hypoglycemia | 0.00 | — |
| Day 28 - Hypoglycemia | 1.04 | — |
| Day 35 - Hypoglycemia | 0.00 | — |
| Day 42 - Hypoglycemia | 0.00 | — |
| Day 49 - Hypoglycemia | 0.00 | — |
| Day 56 - Hypoglycemia | 0.00 | — |
| Day 77 - Hypoglycemia | 0.83 | — |
| Placebo Cohort 2Day 7 - Hyperglycemia | -7.29 | — |
| Day 14 - Hyperglycemia | -15.63 | — |
| Day 21 - Hyperglycemia | 10.42 | — |
| Day 28 - Hyperglycemia | 13.19 | — |
| Day 35 - Hyperglycemia | 2.49 | — |
| Day 42 - Hyperglycemia | -20.49 | — |
| Day 49 - Hyperglycemia | -16.32 | — |
| Day 56 - Hyperglycemia | -16.96 | — |
| Day 77 - Hyperglycemia | -26.74 | — |
| Day 7 - Normoglycemia | 7.64 | — |
| Day 14 - Normoglycemia | 13.89 | — |
| Day 21 - Normoglycemia | -11.11 | — |
| Day 28 - Normoglycemia | -13.54 | — |
| Day 35 - Normoglycemia | -2.14 | — |
| Day 42 - Normoglycemia | 16.67 | — |
| Day 49 - Normoglycemia | 4.86 | — |
| Day 56 - Normoglycemia | 17.31 | — |
| Day 77 - Normoglycemia | 21.88 | — |
| Day 7 - Hypoglycemia | 0.00 | — |
| Day 14 - Hypoglycemia | 0.00 | — |
| Day 21 - Hypoglycemia | 0.00 | — |
| Day 28 - Hypoglycemia | 0.00 | — |
| Day 35 - Hypoglycemia | 0.00 | — |
| Day 42 - Hypoglycemia | 0.00 | — |
| Day 49 - Hypoglycemia | 0.00 | — |
| Day 56 - Hypoglycemia | 0.00 | — |
| Day 77 - Hypoglycemia | 0.00 | — |
| MEDI0382 Cohort 2Day 7 - Hyperglycemia | -22.66 | — |
| Day 14 - Hyperglycemia | -25.91 | — |
| Day 21 - Hyperglycemia | -22.92 | — |
| Day 28 - Hyperglycemia | -21.88 | — |
| Day 35 - Hyperglycemia | -32.30 | — |
| Day 42 - Hyperglycemia | -36.85 | — |
| Day 49 - Hyperglycemia | -42.71 | — |
| Day 56 - Hyperglycemia | -31.40 | — |
| Day 77 - Hyperglycemia | -35.27 | — |
| Day 7 - Normoglycemia | 22.66 | — |
| Day 14 - Normoglycemia | 25.78 | — |
| Day 21 - Normoglycemia | 19.53 | — |
| Day 28 - Normoglycemia | 21.13 | — |
| Day 35 - Normoglycemia | 27.81 | — |
| Day 42 - Normoglycemia | 36.72 | — |
| Day 49 - Normoglycemia | 41.82 | — |
| Day 56 - Normoglycemia | 30.51 | — |
| Day 77 - Normoglycemia | 27.73 | — |
| Day 7 - Hypoglycemia | 0.00 | — |
| Day 14 - Hypoglycemia | 0.00 | — |
| Day 21 - Hypoglycemia | 0.00 | — |
| Day 28 - Hypoglycemia | 0.00 | — |
| Day 35 - Hypoglycemia | 0.00 | — |
| Day 42 - Hypoglycemia | 0.00 | — |
| Day 49 - Hypoglycemia | 0.00 | — |
| Day 56 - Hypoglycemia | 0.00 | — |
| Day 77 - Hypoglycemia | 1.73 | — |
Change From Baseline in Percentage of Time Spent in Hyperglycemia, Normoglycemia, and Clinically Significant Hypoglycemia Over 7 Days as Measured by CGM
Time frame:Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
CGM time-above-range
change from baseline, improvement
Posted result
| Group | Value (mean), Percentage of time spent | 95% CI |
|---|---|---|
| Placebo Cohort 1Days 1 - 7 (Hyperglycemia) | 20.70 | — |
| Days 8 - 14 (Hyperglycemia) | 17.22 | — |
| Days 15 - 21 (Hyperglycemia) | 19.80 | — |
| Days 22 - 28 (Hyperglycemia) | 12.25 | — |
| Days 29 - 35 (Hyperglycemia) | 20.10 | — |
| Days 36 - 42 (Hyperglycemia) | 11.77 | — |
| Days 43 - 49 (Hyperglycemia) | 9.08 | — |
| Days 50 - 56 (Hyperglycemia) | 6.82 | — |
| Days 71 - 77 (Hyperglycemia) | 18.57 | — |
| Days 1 - 7 (Normoglycemia) | -19.94 | — |
| Days 8 - 14 Normoglycemia) | -16.47 | — |
| Days 15 - 21 (Normoglycemia) | -19.20 | — |
| Days 22 - 28 (Normoglycemia) | -12.10 | — |
| Days 29 - 35 (Normoglycemia) | -19.49 | — |
| Days 36 - 42 (Normoglycemia) | -11.31 | — |
| Days 43 - 49 (Normoglycemia) | -8.63 | — |
| Days 50 - 56 (Normoglycemia) | -6.37 | — |
| Days 71 - 77 (Normoglycemia) | -18.27 | — |
| Days 1 - 7 (Hypoglycemia) | 0.00 | — |
| Days 8 - 14 (Hypoglycemia) | 0.00 | — |
| Days 15 - 21 (Hypoglycemia) | 0.00 | — |
| Days 22 - 28 Hypoglycemia) | 0.00 | — |
| Days 29 - 35 (Hypoglycemia) | 0.00 | — |
| Days 36 - 42 (Hypoglycemia) | 0.00 | — |
| Days 43 - 49 (Hypoglycemia) | 0.00 | — |
| Days 50 - 56 (Hypoglycemia) | 0.00 | — |
| Days 71 - 77 (Hypoglycemia) | 0.00 | — |
| MEDI0382 Cohort 1Days 1 - 7 (Hyperglycemia) | -32.73 | — |
| Days 8 - 14 (Hyperglycemia) | -46.85 | — |
| Days 15 - 21 (Hyperglycemia) | -40.52 | — |
| Days 22 - 28 (Hyperglycemia) | -40.92 | — |
| Days 29 - 35 (Hyperglycemia) | -51.69 | — |
| Days 36 - 42 (Hyperglycemia) | -42.48 | — |
| Days 43 - 49 (Hyperglycemia) | -41.92 | — |
| Days 50 - 56 (Hyperglycemia) | -47.70 | — |
| Days 71 - 77 (Hyperglycemia) | -53.98 | — |
| Days 1 - 7 (Normoglycemia) | 32.58 | — |
| Days 8 - 14 Normoglycemia) | 43.41 | — |
| Days 15 - 21 (Normoglycemia) | 40.36 | — |
| Days 22 - 28 (Normoglycemia) | 32.09 | — |
| Days 29 - 35 (Normoglycemia) | 42.95 | — |
| Days 36 - 42 (Normoglycemia) | 40.62 | — |
| Days 43 - 49 (Normoglycemia) | 40.85 | — |
| Days 50 - 56 (Normoglycemia) | 44.10 | — |
| Days 71 - 77 (Normoglycemia) | 46.39 | — |
| Days 1 - 7 (Hypoglycemia) | 0.00 | — |
| Days 8 - 14 (Hypoglycemia) | 1.20 | — |
| Days 15 - 21 (Hypoglycemia) | 0.00 | — |
| Days 22 - 28 Hypoglycemia) | 1.09 | — |
| Days 29 - 35 (Hypoglycemia) | 0.27 | — |
| Days 36 - 42 (Hypoglycemia) | 0.00 | — |
| Days 43 - 49 (Hypoglycemia) | 0.09 | — |
| Days 50 - 56 (Hypoglycemia) | 0.06 | — |
| Days 71 - 77 (Hypoglycemia) | 2.16 | — |
| Placebo Cohort 2Days 1 - 7 (Hyperglycemia) | -8.87 | — |
| Days 8 - 14 (Hyperglycemia) | -17.00 | — |
| Days 15 - 21 (Hyperglycemia) | -9.16 | — |
| Days 22 - 28 (Hyperglycemia) | 6.55 | — |
| Days 29 - 35 (Hyperglycemia) | 4.03 | — |
| Days 36 - 42 (Hyperglycemia) | -17.21 | — |
| Days 43 - 49 (Hyperglycemia) | -16.46 | — |
| Days 50 - 56 (Hyperglycemia) | -18.70 | — |
| Days 71 - 77 (Hyperglycemia) | -16.06 | — |
| Days 1 - 7 (Normoglycemia) | 9.10 | — |
| Days 8 - 14 Normoglycemia) | 17.07 | — |
| Days 15 - 21 (Normoglycemia) | 9.30 | — |
| Days 22 - 28 (Normoglycemia) | -6.27 | — |
| Days 29 - 35 (Normoglycemia) | -3.71 | — |
| Days 36 - 42 (Normoglycemia) | 17.15 | — |
| Days 43 - 49 (Normoglycemia) | 14.07 | — |
| Days 50 - 56 (Normoglycemia) | 18.10 | — |
| Days 71 - 77 (Normoglycemia) | 15.08 | — |
| Days 1 - 7 (Hypoglycemia) | 0.00 | — |
| Days 8 - 14 (Hypoglycemia) | 0.00 | — |
| Days 15 - 21 (Hypoglycemia) | 0.00 | — |
| Days 22 - 28 Hypoglycemia) | 0.00 | — |
| Days 29 - 35 (Hypoglycemia) | 0.00 | — |
| Days 36 - 42 (Hypoglycemia) | 0.00 | — |
| Days 43 - 49 (Hypoglycemia) | 0.40 | — |
| Days 50 - 56 (Hypoglycemia) | 0.20 | — |
| Days 71 - 77 (Hypoglycemia) | 0.15 | — |
| MEDI0382 Cohort 2Days 1 - 7 (Hyperglycemia) | -23.38 | — |
| Days 8 - 14 (Hyperglycemia) | -35.82 | — |
| Days 15 - 21 (Hyperglycemia) | -33.74 | — |
| Days 22 - 28 (Hyperglycemia) | -26.31 | — |
| Days 29 - 35 (Hyperglycemia) | -38.19 | — |
| Days 36 - 42 (Hyperglycemia) | -37.81 | — |
| Days 43 - 49 (Hyperglycemia) | -44.62 | — |
| Days 50 - 56 (Hyperglycemia) | -34.90 | — |
| Days 71 - 77 (Hyperglycemia) | -40.21 | — |
| Days 1 - 7 (Normoglycemia) | 23.34 | — |
| Days 8 - 14 Normoglycemia) | 33.32 | — |
| Days 15 - 21 (Normoglycemia) | 31.82 | — |
| Days 22 - 28 (Normoglycemia) | 22.44 | — |
| Days 29 - 35 (Normoglycemia) | 36.13 | — |
| Days 36 - 42 (Normoglycemia) | 37.45 | — |
| Days 43 - 49 (Normoglycemia) | 42.81 | — |
| Days 50 - 56 (Normoglycemia) | 33.61 | — |
| Days 71 - 77 (Normoglycemia) | 37.93 | — |
| Days 1 - 7 (Hypoglycemia) | 0.00 | — |
| Days 8 - 14 (Hypoglycemia) | 0.28 | — |
| Days 15 - 21 (Hypoglycemia) | 0.20 | — |
| Days 22 - 28 Hypoglycemia) | 0.79 | — |
| Days 29 - 35 (Hypoglycemia) | 0.00 | — |
| Days 36 - 42 (Hypoglycemia) | 0.00 | — |
| Days 43 - 49 (Hypoglycemia) | 0.15 | — |
| Days 50 - 56 (Hypoglycemia) | 0.15 | — |
| Days 71 - 77 (Hypoglycemia) | 0.44 | — |
Change From Baseline in Estimated Hemoglobin A1c (HbA1c) Based on 7-day CGM Glucose Over Time
Time frame:Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49, Days 50-56 of the Up-titration period, and Days 71-77 of end of the treatment extension period
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percent of HbA1C | 95% CI |
|---|---|---|
| Placebo Cohort 1Days 1 - 7 | 1.31 | — |
| Days 8 - 14 | 0.79 | — |
| Days 15 - 21 | 0.48 | — |
| Days 22 - 28 | 0.44 | — |
| Days 29 - 35 | 0.56 | — |
| Days 36 - 42 | 0.78 | — |
| Days 43 - 49 | 0.20 | — |
| Days 50 - 56 | 0.07 | — |
| Days 71 - 77 | 0.75 | — |
| MEDI0382 Cohort 1Days 1 - 7 | -1.21 | — |
| Days 8 - 14 | -1.81 | — |
| Days 15 - 21 | -1.56 | — |
| Days 22 - 28 | -1.86 | — |
| Days 29 - 35 | -2.21 | — |
| Days 36 - 42 | -1.67 | — |
| Days 43 - 49 | -1.68 | — |
| Days 50 - 56 | -1.92 | — |
| Days 71 - 77 | -2.18 | — |
| Placebo Cohort 2Days 1 - 7 | -0.14 | — |
| Days 8 - 14 | -0.50 | — |
| Days 15 - 21 | -0.48 | — |
| Days 22 - 28 | 0.21 | — |
| Days 29 - 35 | 0.01 | — |
| Days 36 - 42 | -0.70 | — |
| Days 43 - 49 | -0.69 | — |
| Days 50 - 56 | -0.68 | — |
| Days 71 - 77 | -0.66 | — |
| MEDI0382 Cohort 2Days 1 - 7 | -0.91 | — |
| Days 8 - 14 | -1.39 | — |
| Days 15 - 21 | -1.33 | — |
| Days 22 - 28 | -0.88 | — |
| Days 29 - 35 | -1.42 | — |
| Days 36 - 42 | -1.24 | — |
| Days 43 - 49 | -1.63 | — |
| Days 50 - 56 | -1.32 | — |
| Days 71 - 77 | -1.40 | — |
Change From Baseline in Fasting Plasma Glucose Over Time
Time frame:Baseline (Day -1), Days 7, 14, 21, 28, 35, 42, 49, 56 of the up-titration period, and Day77 (end of the treatment extension period)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Placebo Cohort 1Day 7 | 9.0 | — |
| Day 14 | -17.5 | — |
| Day 21 | -17.5 | — |
| Day 28 | -17.5 | — |
| Day 35 | 28.5 | — |
| Day 42 | 9.0 | — |
| Day 49 | 23.5 | — |
| Day 56 | -7.5 | — |
| Day 77 | 1.0 | — |
| MEDI0382 Cohort 1Day 7 | -32.0 | — |
| Day 14 | -48.0 | — |
| Day 21 | -48.0 | — |
| Day 28 | -48.0 | — |
| Day 35 | -46.8 | — |
| Day 42 | -42.6 | — |
| Day 49 | -45.6 | — |
| Day 56 | -52.8 | — |
| Day 77 | -47.6 | — |
| Placebo Cohort 2Day 7 | 13.7 | — |
| Day 14 | -3.3 | — |
| Day 21 | -3.3 | — |
| Day 28 | -3.3 | — |
| Day 35 | 5.7 | — |
| Day 42 | 2.0 | — |
| Day 49 | -0.3 | — |
| Day 56 | -9.7 | — |
| Day 77 | -9.7 | — |
| MEDI0382 Cohort 2Day 7 | -27.1 | — |
| Day 14 | -33.9 | — |
| Day 21 | -33.9 | — |
| Day 28 | -33.9 | — |
| Day 35 | -44.4 | — |
| Day 42 | -35.1 | — |
| Day 49 | -38.1 | — |
| Day 56 | -31.3 | — |
| Day 77 | -28.6 | — |
Change From Baseline in HbA1c
Time frame:Baseline (Day -1) through Day 77 (end of the treatment extension period)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percent of HbA1C | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0.10 | — |
| MEDI0382 Cohort 1 | -1.44 | — |
| Placebo Cohort 2 | -0.40 | — |
| MEDI0382 Cohort 2 | -0.59 | — |
Safety / tolerability / PK
16 endpointsNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period
Time frame:Baseline (Day -1) through Day 56 (end of Up-titration period)
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1TEAEs | 2 | — |
| TESAEs | 0 | — |
| MEDI0382 Cohort 1TEAEs | 6 | — |
| TESAEs | 0 | — |
| Placebo Cohort 2TEAEs | 3 | — |
| TESAEs | 0 | — |
| MEDI0382 Cohort 2TEAEs | 8 | — |
| TESAEs | 0 | — |
Number of Participants With TEAEs and TESAEs Through the End of the Follow-up Period
Time frame:Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1TEAEs | 2 | — |
| TESAEs | 0 | — |
| MEDI0382 Cohort 1TEAEs | 6 | — |
| TESAEs | 0 | — |
| Placebo Cohort 2TEAEs | 3 | — |
| TESAEs | 0 | — |
| MEDI0382 Cohort 2TEAEs | 8 | — |
| TESAEs | 0 | — |
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration Period
Time frame:Baseline (Day -1) through Day 56 (end of Up-titration period)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1Atrial fibrillation | 0 | — |
| Supraventricular extrasystoles | 0 | — |
| Ventricular extrasystoles | 0 | — |
| Ventricular tachycardia | 1 | — |
| MEDI0382 Cohort 1Atrial fibrillation | 0 | — |
| Supraventricular extrasystoles | 0 | — |
| Ventricular extrasystoles | 0 | — |
| Ventricular tachycardia | 0 | — |
| Placebo Cohort 2Atrial fibrillation | 0 | — |
| Supraventricular extrasystoles | 0 | — |
| Ventricular extrasystoles | 0 | — |
| Ventricular tachycardia | 0 | — |
| MEDI0382 Cohort 2Atrial fibrillation | 1 | — |
| Supraventricular extrasystoles | 1 | — |
| Ventricular extrasystoles | 1 | — |
| Ventricular tachycardia | 0 | — |
Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up Period
Time frame:Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1Atrial fibrillation | 0 | — |
| Supraventricular extrasystoles | 0 | — |
| Ventricular extrasystoles | 0 | — |
| Ventricular tachycardia | 1 | — |
| MEDI0382 Cohort 1Atrial fibrillation | 0 | — |
| Supraventricular extrasystoles | 0 | — |
| Ventricular extrasystoles | 0 | — |
| Ventricular tachycardia | 0 | — |
| Placebo Cohort 2Atrial fibrillation | 0 | — |
| Supraventricular extrasystoles | 0 | — |
| Ventricular extrasystoles | 0 | — |
| Ventricular tachycardia | 0 | — |
| MEDI0382 Cohort 2Atrial fibrillation | 1 | — |
| Supraventricular extrasystoles | 1 | — |
| Ventricular extrasystoles | 1 | — |
| Ventricular tachycardia | 0 | — |
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Up-titration Period
Time frame:Baseline (Day -1) through Day 56 (end of Up-titration period)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0 | — |
| MEDI0382 Cohort 1 | 1 | — |
| Placebo Cohort 2 | 0 | — |
| MEDI0382 Cohort 2 | 0 | — |
Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Follow-up Period
Time frame:Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0 | — |
| MEDI0382 Cohort 1 | 1 | — |
| Placebo Cohort 2 | 0 | — |
| MEDI0382 Cohort 2 | 0 | — |
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Up-titration Period
Time frame:Baseline (Day -1) through Day 56 (end of Up-titration period)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0 | — |
| MEDI0382 Cohort 1 | 3 | — |
| Placebo Cohort 2 | 0 | — |
| MEDI0382 Cohort 2 | 4 | — |
Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Follow-up Period
Time frame:Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0 | — |
| MEDI0382 Cohort 1 | 3 | — |
| Placebo Cohort 2 | 0 | — |
| MEDI0382 Cohort 2 | 4 | — |
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Up-titration Period
Time frame:Baseline (Day -1) through Day 56 (end of Up-titration period)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0 | — |
| MEDI0382 Cohort 1 | 1 | — |
| Placebo Cohort 2 | 0 | — |
| MEDI0382 Cohort 2 | 0 | — |
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Follow-up Period
Time frame:Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1 | 0 | — |
| MEDI0382 Cohort 1 | 1 | — |
| Placebo Cohort 2 | 0 | — |
| MEDI0382 Cohort 2 | 0 | — |
Area Under the Plasma Concentration Time Curve Over a Dosing Interval (AUCτ) of MEDI0382
Time frame:Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng.hr/mL | 95% CI |
|---|---|---|
| MEDI0382 (Cohort 1 + Cohort 2)Day 1 | 20.9 | 15.9 – 29.0 |
| Day 7 | 23.7 | 17.2 – 41.3 |
| Day 14 | 59.9 | 35.8 – 101 |
| Day 35 | 276 | 183 – 694 |
| Day 42 | 332 | 247 – 735 |
| Day 49 | 434 | 308 – 752 |
| Day 56 | 611 | 343 – 2840 |
| Day 84 | 661 | 372 – 4740 |
Maximum Observed Serum Concentration (Cmax) of MEDI0382
Time frame:Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| MEDI0382 (Cohort 1 + Cohort 2)Day 1 | 1.02 | 0.447 – 1.84 |
| Day 7 | 1.35 | 0.934 – 2.51 |
| Day 14 | 3.43 | 2.02 – 6.37 |
| Day 35 | 15.3 | 9.74 – 36.1 |
| Day 42 | 17.8 | 12.7 – 37.8 |
| Day 49 | 24.9 | 15.2 – 39.0 |
| Day 56 | 32.8 | 17.7 – 137 |
| Day 84 | 35.3 | 19.7 – 202 |
Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382
Time frame:Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Tmax
descriptive
Posted result
| Group | Value (median), hours | 95% CI |
|---|---|---|
| MEDI0382 (Cohort 1 + Cohort 2)Day 1 | 6.02 | 4.00 – 8.00 |
| Day 7 | 6.00 | 4.00 – 8.00 |
| Day 14 | 6.00 | 4.00 – 8.00 |
| Day 35 | 6.00 | 4.00 – 8.00 |
| Day 42 | 6.00 | 2.00 – 8.00 |
| Day 49 | 6.00 | 4.00 – 8.00 |
| Day 56 | 6.00 | 4.00 – 8.00 |
| Day 84 | 6.00 | 0.00 – 8.00 |
Trough Plasma Concentration (Ctrough) of MEDI0382
Time frame:Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| MEDI0382 (Cohort 1 + Cohort 2)Day 7 | 0.551 | 0.401 – 0.775 |
| Day 14 | 1.46 | 0.617 – 2.56 |
| Day 22 | 2.01 | 1.09 – 3.27 |
| Day 29 | 4.65 | 2.10 – 27.0 |
| Day 35 | 6.92 | 3.85 – 23.2 |
| Day 42 | 8.85 | 5.09 – 26.4 |
| Day 49 | 11.0 | 5.86 – 23.7 |
| Day 56 | 16.3 | 9.70 – 131 |
| Day 70 | 13.6 | 8.22 – 29.5 |
| Day 84 | 18.8 | 7.99 – 178 |
Observed Accumulation Ratio (Ro) of MEDI0382 Calculated Using AUC
Time frame:Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dose on Days 1, 7, 14, 35, 42, 49 and 56; pre-dose on Days 22, 29, 70, 84; additional 48 and 72 hours post-dose on Day 84
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | 95% CI |
|---|---|---|
| MEDI0382 (Cohort 1 + Cohort 2)Day 1 | NA | NA – NA |
| Day 7 | 1.25 | 1.09 – 1.65 |
| Day 14 | 1.40 | 1.22 – 1.72 |
| Day 35 | 1.01 | 0.761 – 1.81 |
| Day 42 | 0.857 | 0.503 – 1.44 |
| Day 49 | 0.904 | 0.603 – 1.18 |
| Day 56 | 1.16 | 0.691 – 5.32 |
| Day 84 | 1.30 | 0.526 – 8.89 |
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382 Treatment
Time frame:Pre-dose (Day -2), Days 7, 14, 35, 42, 56; Day 21 of 3 week treatment extension, and 28 days post last dose (approximately 5 months)
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Cohort 1Positive at baseline | 0 | — |
| Positive post-baseline | 0 | — |
| Positive at baseline and post-baseline | 0 | — |
| Not detected at baseline; positive post-baseline | 0 | — |
| Positive at baseline; not detected post-baseline | 0 | — |
| MEDI0382 Cohort 1Positive at baseline | 0 | — |
| Positive post-baseline | 3 | — |
| Positive at baseline and post-baseline | 0 | — |
| Not detected at baseline; positive post-baseline | 3 | — |
| Positive at baseline; not detected post-baseline | 0 | — |
| Placebo Cohort 2Positive at baseline | 0 | — |
| Positive post-baseline | 0 | — |
| Positive at baseline and post-baseline | 0 | — |
| Not detected at baseline; positive post-baseline | 0 | — |
| Positive at baseline; not detected post-baseline | 0 | — |
| MEDI0382 Cohort 2Positive at baseline | 1 | — |
| Positive post-baseline | 4 | — |
| Positive at baseline and post-baseline | 1 | — |
| Not detected at baseline; positive post-baseline | 3 | — |
| Positive at baseline; not detected post-baseline | 1 | — |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.