DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02548585

CompletedPhase 1, PHASE2Results posted

A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects With a History of Type 2 Diabetes Mellitus

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

11

Recruiting sites

—

Enrollment

113

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Postprandial glucose•Body weight, absolute change (kg)

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

NCT IDNCT02548585
Org study IDD5670C00002

Timeline

Milestones

Study first posted2015-09-14estimated
Study start2015-12-09actual
Primary completion2017-02-24actual
Study completion2017-02-24actual
Last update posted2019-04-05actual
Results first posted2019-04-05actual

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of T2DM
•Must provide written informed consent
•Body mass index greater than (>) 27 and less than (<) 40 kg/m^2, inclusive
•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 effective contraceptive measures if sexually active

Exclusion criteria

•Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
•History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
•History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
•Any clinically important illness (except for T2DM), medical/surgical procedure, or trauma within 4 weeks prior to dosing
•Fasting glucose greater than or equal to (>=) 200 mg/dL
•Positive Hepatitis B, Hepatitis C or human immunodeficiency virus test or use of antiretroviral medications at screening.
•Concurrent or previous use of a glucagon-like peptide 1 receptor agonist
•Current or previous use of systemic corticosteroids within the past 28 days prior to screening
•Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
•Known or suspected history of alcohol or drug abuse within the past 3 years.
•Positive drug screen

Endpoints (26)

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

Safety / tolerability / PK
14
Glycemic / diabetes
10
Weight & body composition
2

Weight & body composition

2 endpoints
Primary/protocol endpoint

Change From Baseline in Body Weight to the EOT (Cohort 4)

Time frame:Baseline (Day 1) and EOT (Day 42)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms (Kg)95% CI
Cohort 4: Placebo-1.71—
Cohort 4: MEDI0382 200 mcg-3.83—
p0.0008ANCOVA
Secondary/protocol endpoint

Change From Baseline in Body Weight to the EOT (Cohorts 1, 2, 3, 5, and 6)

Time frame:Cohort 1: Baseline (Day 1) to EOT (Day 8); Cohort 2: Baseline (Day 1) to EOT (Day 12); Cohort 3: Baseline (Day 1) to EOT (Day 16); Cohort 5: Baseline (Day 1) to EOT (Day 22); Cohort 6: Baseline (Day 1) to EOT (Day 17)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kg95% CI
Cohort 1: Placebo-1.20—
Cohort 1: MEDI0382 100 mcg-2.32—
Cohort 2: Placebo-1.00—
Cohort 2: MEDI0382 150 mcg-1.52—
Cohort 3: Placebo-2.90—
Cohort 3: MEDI0382 200 mcg-4.63—
Cohort 5: Placebo-0.98—
Cohort 5: MEDI0382 300 mcg-3.26—
Cohort 6: Placebo-0.94—
Cohort 6: MEDI0382 300 mcg-2.04—

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41)

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 4: Placebo-9.24—
Cohort 4: MEDI0382 200 mcg-33.81—
p< 0.0001ANCOVA
Secondary/protocol endpoint

Percent Change From Baseline in MMT Glucose AUC0-4h to the EOT (Cohorts 1, 2, 3, 5, and 6)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 22 for Cohort 5; and Day 17 for Cohort 6)

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 1: Placebo-14.60—
Cohort 1: MEDI0382 100 mcg-41.80—
Cohort 2: Placebo-15.07—
Cohort 2: MEDI0382 150 mcg-36.73—
Cohort 3: Placebo-0.47—
Cohort 3: MEDI0382 200 mcg-39.58—
Cohort 5: Placebo-14.52—
Cohort 5: MEDI0382 300 mcg-41.66—
Cohort 6: Placebo-4.80—
Cohort 6: MEDI0382 300 mcg-38.19—
Secondary/protocol endpoint

Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)

Time frame:Cohort 4: Baseline (Day -2) to EOT (Day 42); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percent change95% CI
Cohort 4: Placebo-0.58—
Cohort 4: MEDI0382 200 mcg-0.92—
Cohort 5: Placebo-0.10—
Cohort 5: MEDI0382 300 mcg-0.55—
Cohort 6: Placebo-0.18—
Cohort 6: MEDI0382 300 mcg-0.42—
Secondary/protocol endpoint

Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)

Time frame:Cohort 4: Baseline (Day -2) to EOT (Day 41); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)

change from baseline, improvement

Posted result

GroupValue (mean), micromol/L95% CI
Cohort 4: Placebo-33.7—
Cohort 4: MEDI0382 200 mcg-67.9—
Cohort 5: Placebo-27.8—
Cohort 5: MEDI0382 300 mcg-47.4—
Cohort 6: Placebo-48.8—
Cohort 6: MEDI0382 300 mcg-47.5—
Secondary/protocol endpoint

Change From Baseline in Fasting Glucose Prior to MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:Cohort 1: Baseline (Day-1) to EOT (Day7); Cohort 2: Baseline (Day-1) to EOT (Day11); Cohort 3: Baseline (Day-1) to EOT (Day15); Cohort 4: Baseline (Day-1) to EOT (Day41); Cohort 5: Baseline (Day-1) to EOT (Day22); Cohort 6: Baseline (Day-1) to EOT (Day17)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
Cohort 1: Placebo-32.44—
Cohort 1: MEDI0382 100 mcg-74.48—
Cohort 2: Placebo-49.86—
Cohort 2: MEDI0382 150 mcg-54.06—
Cohort 3: Placebo-4.20—
Cohort 3: MEDI0382 200 mcg-63.67—
Cohort 4: Placebo-18.52—
Cohort 4: MEDI0382 200 mcg-50.62—
Cohort 5: Placebo-32.08—
Cohort 5: MEDI0382 300 mcg-54.42—
Cohort 6: Placebo-16.58—
Cohort 6: MEDI0382 300 mcg-55.21—
Secondary/protocol endpoint

Percent Change From Baseline in Glucose Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) After MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, 240 minutes, and 24 hrs post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 1: Placebo-21.80—
Cohort 1: MEDI0382 100 mcg-28.34—
Cohort 2: Placebo0.80—
Cohort 2: MEDI0382 150 mcg-29.32—
Cohort 3: Placebo-13.80—
Cohort 3: MEDI0382 200 mcg-27.07—
Cohort 4: Placebo-1.06—
Cohort 4: MEDI0382 200 mcg-13.50—
Cohort 5: Placebo-4.20—
Cohort 5: MEDI0382 300 mcg-34.51—
Cohort 6: Placebo-10.10—
Cohort 6: MEDI0382 300 mcg-26.95—
Secondary/protocol endpoint

Percent Change From Baseline in Insulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 1: Placebo10.83—
Cohort 1: MEDI0382 100 mcg-9.37—
Cohort 2: Placebo-3.67—
Cohort 2: MEDI0382 150 mcg36.32—
Cohort 3: Placebo-20.43—
Cohort 3: MEDI0382 200 mcg-17.47—
Cohort 4: Placebo-8.63—
Cohort 4: MEDI0382 200 mcg-1.17—
Cohort 5: Placebo-17.70—
Cohort 5: MEDI0382 300 mcg1.01—
Cohort 6: Placebo-8.18—
Cohort 6: MEDI0382 300 mcg-7.72—
Secondary/protocol endpoint

Percent Change From Baseline in Proinsulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 1: Placebo-3.27—
Cohort 1: MEDI0382 100 mcg-52.10—
Cohort 2: Placebo-33.13—
Cohort 2: MEDI0382 150 mcg-36.77—
Cohort 3: Placebo81.27—
Cohort 3: MEDI0382 200 mcg-54.13—
Cohort 4: Placebo-29.72—
Cohort 4: MEDI0382 200 mcg-47.93—
Secondary/protocol endpoint

Percent Change From Baseline in C-peptide AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)

C-peptide AUC

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 1: Placebo10.17—
Cohort 1: MEDI0382 100 mcg-3.82—
Cohort 2: Placebo-1.43—
Cohort 2: MEDI0382 150 mcg39.78—
Cohort 3: Placebo79.37—
Cohort 3: MEDI0382 200 mcg-9.07—
Cohort 4: Placebo8.08—
Cohort 4: MEDI0382 200 mcg15.66—
Secondary/protocol endpoint/low confidence

Percent Change From Baseline in Incretin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)

Time frame:0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Cohort 1: PlaceboGLP-1, Active: Change at EOT8.30—
GLP-1, Inactive: Change at EOT-20.30—
Glucagon: Change at EOT-13.85—
GIP: Change at EOT18.00—
Cohort 1: MEDI0382 100 mcgGLP-1, Active: Change at EOT-33.67—
GLP-1, Inactive: Change at EOT0.70—
Glucagon: Change at EOT-20.25—
GIP: Change at EOT-46.50—
Cohort 2: PlaceboGLP-1, Active: Change at EOT-10.40—
GLP-1, Inactive: Change at EOT-22.90—
Glucagon: Change at EOT-17.53—
GIP: Change at EOT4.10—
Cohort 2: MEDI0382 150 mcgGLP-1, Active: Change at EOT-50.45—
GLP-1, Inactive: Change at EOT-10.93—
Glucagon: Change at EOT-38.12—
GIP: Change at EOT-27.08—
Cohort 3: PlaceboGLP-1, Active: Change at EOT-2.87—
GLP-1, Inactive: Change at EOT1.75—
Glucagon: Change at EOT-18.73—
GIP: Change at EOT-6.30—
Cohort 3: MEDI0382 200 mcgGLP-1, Active: Change at EOT-40.36—
GLP-1, Inactive: Change at EOT-8.07—
Glucagon: Change at EOT-3.05—
GIP: Change at EOT-21.34—
Cohort 4: PlaceboGLP-1, Active: Change at EOT1.63—
GLP-1, Inactive: Change at EOT3.99—
Glucagon: Change at EOT-1.76—
GIP: Change at EOT-6.60—
Cohort 4: MEDI0382 200 mcgGLP-1, Active: Change at EOT-49.73—
GLP-1, Inactive: Change at EOT-28.85—
Glucagon: Change at EOT-30.17—
GIP: Change at EOT-37.38—

Safety / tolerability / PK

14 endpoints
Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Time frame:From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 1: PlaceboTEAEs2—
TESAEs0—
Cohort 1: MEDI0382 100 mcgTEAEs6—
TESAEs0—
Cohort 2: PlaceboTEAEs3—
TESAEs0—
Cohort 2: MEDI0382 150 mcgTEAEs5—
TESAEs0—
Cohort 3: PlaceboTEAEs3—
TESAEs0—
Cohort 3: MEDI0382 200 mcgTEAEs7—
TESAEs1—
Cohort 4: PlaceboTEAEs23—
TESAEs1—
Cohort 4: MEDI0382 200 mcgTEAEs22—
TESAEs0—
Cohort 5: PlaceboTEAEs4—
TESAEs0—
Cohort 5: MEDI0382 300 mcgTEAEs10—
TESAEs0—
Cohort 6: PlaceboTEAEs2—
TESAEs0—
Cohort 6: MEDI0382 300 mcgTEAEs10—
TESAEs0—
Secondary/protocol endpoint

Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs

Time frame:From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 1: PlaceboBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 1: MEDI0382 100 mcgBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 2: PlaceboBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 2: MEDI0382 150 mcgBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 3: PlaceboBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 3: MEDI0382 200 mcgBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 4: PlaceboBlood Pressure increased2—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 4: MEDI0382 200 mcgBlood Pressure increased1—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 5: PlaceboBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 5: MEDI0382 300 mcgBlood Pressure increased0—
Blood pressure systolic increased1—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 6: PlaceboBlood Pressure increased0—
Blood pressure systolic increased1—
Blood pressure diastolic increased0—
Physical Examinations0—
Cohort 6: MEDI0382 300 mcgBlood Pressure increased0—
Blood pressure systolic increased0—
Blood pressure diastolic increased1—
Physical Examinations0—
Secondary/protocol endpoint

Number of Participants With Abnormal 12 Lead Electrocardiogram (ECG) Reported as TEAEs

Time frame:From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 1: PlaceboArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia1—
Tachycardia0—
Ventricular extrasystoles0—
Ventricular tachycardia0—
Cohort 1: MEDI0382 100 mcgArrhythmia1—
Atrial fibrillation0—
Atrioventricular block first degree1—
Atrioventricular block second degree1—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia1—
Tachycardia1—
Ventricular extrasystoles1—
Ventricular tachycardia0—
Cohort 2: PlaceboArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles1—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia1—
Tachycardia0—
Ventricular extrasystoles1—
Ventricular tachycardia0—
Cohort 2: MEDI0382 150 mcgArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia0—
Tachycardia1—
Ventricular extrasystoles1—
Ventricular tachycardia0—
Cohort 3: PlaceboArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles1—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia1—
Tachycardia0—
Ventricular extrasystoles0—
Ventricular tachycardia1—
Cohort 3: MEDI0382 200 mcgArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression1—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia1—
Tachycardia1—
Ventricular extrasystoles0—
Ventricular tachycardia1—
Cohort 4: PlaceboArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles1—
Supraventricular tachycardia0—
Tachycardia0—
Ventricular extrasystoles1—
Ventricular tachycardia0—
Cohort 4: MEDI0382 200 mcgArrhythmia0—
Atrial fibrillation1—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia1—
Supraventricular extrasystoles0—
Supraventricular tachycardia0—
Tachycardia0—
Ventricular extrasystoles1—
Ventricular tachycardia0—
Cohort 5: PlaceboArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia0—
Tachycardia0—
Ventricular extrasystoles0—
Ventricular tachycardia0—
Cohort 5: MEDI0382 300 mcgArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia0—
Tachycardia0—
Ventricular extrasystoles0—
Ventricular tachycardia0—
Cohort 6: PlaceboArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia0—
Tachycardia0—
Ventricular extrasystoles0—
Ventricular tachycardia0—
Cohort 6: MEDI0382 300 mcgArrhythmia0—
Atrial fibrillation0—
Atrioventricular block first degree0—
Atrioventricular block second degree0—
Electrocardiogram ST segment depression0—
Extrasystoles0—
Sinus tachycardia0—
Supraventricular extrasystoles0—
Supraventricular tachycardia0—
Tachycardia0—
Ventricular extrasystoles0—
Ventricular tachycardia0—
Secondary/protocol endpoint

Number of Participants With Abnormal Clinical Laboratory Reported as TEAEs

Time frame:From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 1: PlaceboLipase increased0—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 1: MEDI0382 100 mcgLipase increased0—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 2: PlaceboLipase increased0—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 2: MEDI0382 150 mcgLipase increased1—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 3: PlaceboLipase increased0—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 3: MEDI0382 200 mcgLipase increased0—
Hypokalemia0—
C-reactive protein increased1—
Hypoglycemia0—
Chromaturia0—
Cohort 4: PlaceboLipase increased0—
Hypokalemia1—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 4: MEDI0382 200 mcgLipase increased1—
Hypokalemia1—
C-reactive protein increased0—
Hypoglycemia1—
Chromaturia1—
Cohort 5: PlaceboLipase increased0—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 5: MEDI0382 300 mcgLipase increased2—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia1—
Cohort 6: PlaceboLipase increased0—
Hypokalemia0—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Cohort 6: MEDI0382 300 mcgLipase increased1—
Hypokalemia1—
C-reactive protein increased0—
Hypoglycemia0—
Chromaturia0—
Secondary/protocol endpoint

Number of Participants With Any Suicidal Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score (Cohorts 4, 5, and 6)

Time frame:Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 4: PlaceboDay -11—
Day 131—
Day 200—
Day 270—
Day 340—
Day 400—
Cohort 4: MEDI0382 200 mcgDay -14—
Day 130—
Day 200—
Day 270—
Day 340—
Day 400—
Cohort 5: PlaceboDay -10—
Days 7-14 post last dose of MEDI03820—
Cohort 5: MEDI0382 300 mcgDay -12—
Days 7-14 post last dose of MEDI03821—
Cohort 6: PlaceboDay -10—
Days 7-14 post last dose of MEDI03820—
Cohort 6: MEDI0382 300 mcgDay -12—
Days 7-14 post last dose of MEDI03820—
Secondary/protocol endpoint

Number of Participants With Any Suicidal Behaviour as Assessed by C-SSRS Score (Cohorts 4, 5, and 6)

Time frame:Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 4: PlaceboDay -12—
Day 131—
Day 200—
Day 270—
Day 340—
Day 400—
Cohort 4: MEDI0382 200 mcgDay -12—
Day 130—
Day 200—
Day 270—
Day 340—
Day 400—
Cohort 5: PlaceboDay -10—
Days 7-14 post last dose of MEDI03820—
Cohort 5: MEDI0382 300 mcgDay -11—
Days 7-14 post last dose of MEDI03820—
Cohort 6: PlaceboDay -10—
Days 7-14 post last dose of MEDI03820—
Cohort 6: MEDI0382 300 mcgDay -11—
Days 7-14 post last dose of MEDI03820—
Secondary/protocol endpoint

Terminal Elimination Half Life (t1/2) of MEDI0382 (Cohorts 1, 2, and 3)

Time frame:Cohort (C) 1 (Day [D] 1 and [&] D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose

Half-life

descriptive

Posted result

GroupValue (geometric_mean), hr95% CI
Cohort 1: MEDI0382 100 mcgDay 18.5NA – NA
Day 711.75.5 – 25.1
Cohort 2: MEDI0382 150 mcgDay 510.37.8 – 13.5
Day 1111.35.9 – 21.7
Cohort 3: MEDI0382 200 mcgDay 98.3NA – NA
Day 1511.38.2 – 15.5
Secondary/protocol endpoint

Accumulation Ratio (Rac) of MEDI0382 (Cohorts 1, 2, and 3)

Time frame:C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose

AUC₀–∞

descriptive

Posted result

GroupValue (geometric_mean), Ratio95% CI
Cohort 1: MEDI0382 100 mcgDay 1NANA – NA
Day 71.31.1 – 1.5
Cohort 2: MEDI0382 150 mcgDay 5NANA – NA
Day 111.10.9 – 1.8
Cohort 3: MEDI0382 200 mcgDay 9NANA – NA
Day 151.31.1 – 1.5
Secondary/protocol endpoint

Area Under the Concentration Time Curve From Time Zero to End of Dosing Interval (AUC[0-tau]) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*hr/mL95% CI
Cohort 1: MEDI0382 100 mcgDay 182.2144.56 – 151.69
Day 7107.0154.10 – 211.64
Cohort 2: MEDI0382 150 mcgDay 5174.5887.41 – 348.67
Day 11157.3182.45 – 421.12
Cohort 3: MEDI0382 200 mcgDay 9194.78146.17 – 259.56
Day 15195.4089.8 – 425.17
Cohort 4: MEDI0382 200 mcgDay 9164.0542.67 – 630.76
Day 41199.1084.57 – 468.75
Cohort 6: MEDI0382 300 mcgDay 11275.29169.33 – 447.48
Day 17246.06130.34 – 464.51
Cohort 5: MEDI0382 300 mcgDay 16261.90166.58 – 411.74
Day 22254.35196.10 – 329.9
Secondary/protocol endpoint

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*hr/mL95% CI
Cohort 1: MEDI0382 100 mcgDay 1103.46NA – NA
Day 7184.68107.76 – 316.51
Cohort 2: MEDI0382 150 mcgDay 5207.1511.98 – 3580.41
Day 11215.80112.90 – 412.47
Cohort 3: MEDI0382 200 mcgDay 9242.60NA – NA
Day 15271.84119.33 – 619.24
Cohort 4: MEDI0382 200 mcgDay 9238.2280.99 – 700.67
Day 41262.1799.79 – 688.77
Cohort 5: MEDI0382 300 mcgDay 16317.93182.24 – 554.64
Day 22294.60172.52 – 503.05
Cohort 6: MEDI0382 300 mcgDay 17327.28249.98 – 428.49
Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
Cohort 1: MEDI0382 100 mcgDay 14.970.33 – 7.41
Day 76.263.36 – 11.67
Cohort 2: MEDI0382 150 mcgDay 59.664.68 – 19.95
Day 119.574.63 – 19.79
Cohort 3: MEDI0382 200 mcgDay 910.576.33 – 17.66
Day 1510.974.62 – 26.06
Cohort 4: MEDI0382 200 mcgDay 911.643.16 – 42.94
Day 4113.424.77 – 37.75
Cohort 6: MEDI0382 300 mcgDay 1113.695.73 – 32.71
Day 1715.557.55 – 32.01
Cohort 5: MEDI0382 300 mcgDay 1617.658.82 – 35.29
Day 2215.7710.02 – 24.8
Secondary/protocol endpoint

Minimum Observed Plasma Concentration (Cmin) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
Cohort 1: MEDI0382 100 mcgDay 10.7050.33 – 1.49
Day 72.3721.18 – 4.78
Cohort 2: MEDI0382 150 mcgDay 52.6851.06 – 6.79
Day 113.591.62 – 7.94
Cohort 3: MEDI0382 200 mcgDay 93.5212.16 – 5.75
Day 154.9732.24 – 11.05
Cohort 4: MEDI0382 200 mcgDay 92.6350.79 – 8.83
Day 413.381.03 – 11.04
Cohort 6: MEDI0382 300 mcgDay 113.5861.45 – 8.88
Day 174.7662.74 – 8.3
Cohort 5: MEDI0382 300 mcgDay 164.0621.68 – 9.84
Day 225.211.97 – 13.81
Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose

Tmax

descriptive

Posted result

GroupValue (median), hr95% CI
Cohort 1: MEDI0382 100 mcgDay 186 – 8
Day 764 – 6
Cohort 2: MEDI0382 150 mcgDay 564 – 8
Day 1164 – 6
Cohort 3: MEDI0382 200 mcgDay 966 – 8
Day 1564 – 8
Cohort 4: MEDI0382 200 mcgDay 941 – 6
Day 4144 – 8
Cohort 6: MEDI0382 300 mcgDay 1164 – 12
Day 1742 – 6
Cohort 5: MEDI0382 300 mcgDay 1642 – 8
Day 2244 – 8
Secondary/protocol endpoint

Number of Participants With Positive Anti-drug Antibodies to MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)

Time frame:Day 1 up to 7-14 days post-last dose of MEDI0382 for all cohorts (Approximately 60 days)

Immunogenicity (ADA)

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Cohort 1: Placebo0—
Cohort 1: MEDI0382 100 mcg0—
Cohort 2: Placebo1—
Cohort 2: MEDI0382 150 mcg0—
Cohort 3: Placebo0—
Cohort 3: MEDI0382 200 mcg0—
Cohort 4: Placebo0—
Cohort 4: MEDI0382 200 mcg0—
Cohort 5: Placebo0—
Cohort 5: MEDI0382 300 mcg0—
Cohort 6: Placebo0—
Cohort 6: MEDI0382 300 mcg0—

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.