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CompletedPhase 2Results posted

A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

5

Recruiting sites

Enrollment

65

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 27-40HbA1c 6.5-8.5%

Primary endpoints

Postprandial glucoseBody weight, % change

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 IDNCT03244800
Org study IDD5670C00011

Timeline

Milestones

Study first posted2017-08-10actual
Study start2017-09-04actual
Primary completion2018-01-23actual
Study completion2018-01-23actual
Last update posted2019-11-19actual
Results first posted2019-11-19actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age130 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male and female subjects aged ≥ 18 years at screening

2. Provision of signed and dated written informed consent

3. BMI between 27 and 40 kg/m2

4. HbA1c range of 6.5% to 8.5%

5. Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred in the 3 months prior to screening

6. Subjects prescribed oral dual therapy with a dipeptidyl peptidase-4 inhibitor, sulphonylurea, glitinide, or a sodium-glucose co-transporter 2 inhibitor in addition to metformin at screening may be eligible to enter the study following a 4-week washout period

7. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating

8. Females of childbearing potential who are sexually active with a nonsterilised male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Exclusion criteria

1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, 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

2. Concurrent participation in another study of any kind and repeat randomisation in this study is prohibited

3. Severe allergy/hypersensitivity to any of the proposed study treatments

4. 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 subject has been treated with daily SC insulin within 90 days prior to screening

5. Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data

6. Significant hepatic disease (except for non-alcoholic steatohepatitis or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:

Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
Alanine transaminase (ALT) ≥ 3 × ULN
Total bilirubin ≥ 2 × ULN

7. Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73 m2 at screening (GFR estimated according to Modification of Diet in Renal Disease [MDRD] using the isotope dilution mass spectrometry [IDMS] traceable MDRD Study Equation [SI units])

8. Poorly controlled hypertension defined as:

Systolic BP > 160 mm Hg
Diastolic BP ≥ 95 mm Hg after 10 minutes of seated rest and confirmed by repeated measurement at screening.

9. Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or subjects 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

10. Severe congestive heart failure (New York Heart Association Class III or IV)

11. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia

12. Haemoglobinopathy, haemolytic anemia, or chronic anaemia (haemoglobin concentration < 11.5 g/dL [115 g/L] for males, < 10.5 g/dL [105 g/L] for females) at screening or any other condition known to interfere with interpretation of HbA1c measurement

13. 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

14. Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibody

15. History of substance dependence, alcohol abuse, or excessive alcohol intake (defined as an average weekly intake of > 21 alcoholic drinks for men or > 10 alcoholic drinks for women) within 3 years prior to screening, and/or a positive screen for drugs of abuse or alcohol at screening or on admission to the study unit. Subjects who use tricyclic antidepressants or benzodiazepines for an established clinical indication may be permitted to enter the study based upon the judgement of the investigator.

16. Involvement of any AstraZeneca, MedImmune, contract research organization, or study site employee or their close relatives

17. History of acute or chronic pancreatitis or other diseases of the pancreas

Endpoints (25)

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
18
Glycemic / diabetes
4
Weight & body composition
3

Weight & body composition

3 endpoints
Primary/protocol endpoint

Cohort 1: Percent Change From Baseline in Body Weight to Day 50

Time frame:Day 1 through Day 50

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change95% CI
Placebo Cohort 1-0.21-1.88 – 1.46
MEDI0382 Cohort 1-3.59-4.77 – -2.41
p0.002ANCOVA
Secondary/protocol endpoint

Cohort 1: Change From Baseline in Body Weight to Day 50

Time frame:Day 1 through Day 50

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Kilogram95% CI
Placebo Cohort 1-0.08-1.45 – 1.28
MEDI0382 Cohort 1-3.41-4.37 – -2.44
p0.002ANCOVA
Secondary/protocol endpoint

Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50

Time frame:Day 1 through Day 50

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of Participants95% CI
Placebo Cohort 17.7
MEDI0382 Cohort 142.3
Odds Ratio (OR)10.7690% CI1.6172.03p0.040Regression, Logistic

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49

Time frame:Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change95% CI
Placebo Cohort 16.32-0.74 – 13.38
MEDI0382 Cohort 1-21.52-26.51 – -16.54
p<0.001ANCOVA
Secondary/protocol endpoint

Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49

Time frame:Baseline (Day -1) through Day 49

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percentage change95% CI
Placebo Cohort 1-0.07-0.27 – 0.14
MEDI0382 Cohort 1-0.67-0.82 – -0.53
p<0.001ANCOVA
Secondary/protocol endpoint

Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49

Time frame:Baseline (Day -1) through Day 49

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), mg/dL95% CI
Placebo Cohort 1-2.31-12.74 – 8.13
MEDI0382 Cohort 1-35.37-42.75 – -27.99
p<0.001ANCOVA
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7

Time frame:Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (mean), Percent change95% CI
Placebo Cohort 1-2.02
MEDI0382 Cohort 1-27.17
Placebo Cohort 21.77
MEDI0382 Cohort 2-31.80

Safety / tolerability / PK

18 endpoints
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Time frame:From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)

Treatment-emergent AEs (any)

event count, event

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

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo Cohort 1TEAEs6
TESAEs0
MEDI0382 Cohort 1TEAEs22
TESAEs0
Placebo Cohort 2TEAEs3
TESAEs0
MEDI0382 Cohort 2TEAEs15
TESAEs0
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs

Time frame:From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo Cohort 10
MEDI0382 Cohort 10
Placebo Cohort 20
MEDI0382 Cohort 20
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs

Time frame:From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo Cohort 10
MEDI0382 Cohort 10
Placebo Cohort 20
MEDI0382 Cohort 21
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

Time frame:From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo Cohort 1Thrombocytopenia0
Hypoglycaemia0
MEDI0382 Cohort 1Thrombocytopenia0
Hypoglycaemia1
Placebo Cohort 2Thrombocytopenia0
Hypoglycaemia0
MEDI0382 Cohort 2Thrombocytopenia1
Hypoglycaemia1
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema

Time frame:From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo Cohort 10
MEDI0382 Cohort 10
Placebo Cohort 20
MEDI0382 Cohort 25
Secondary/protocol endpoint

Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382

Time frame:Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*hr/mL95% CI
MEDI0382 Cohort 1Day 22226.31103.95 – 488.98
Day 49248.8386.57 – 558.57
Secondary/protocol endpoint

Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382

Time frame:Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*hr/mL95% CI
MEDI0382 Cohort 2Day 138.6734.05 – 47.25
Day 737.518.99 – 69.82
Day 1446.7526.38 – 65.61
Secondary/protocol endpoint

Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382

Time frame:Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI0382 Cohort 1Day 2213.244.89 – 30.3
Day 4914.85.76 – 33.3
Secondary/protocol endpoint

Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382

Time frame:Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI0382 Cohort 2Day 12.001.09 – 3.25
Day 72.530.85 – 4.14
Day 142.651.50 – 3.77
Secondary/protocol endpoint

Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382

Time frame:Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49

Tmax

descriptive

Posted result

GroupValue (median), Hours95% CI
MEDI0382 Cohort 1Day 2264 – 12
Day 4942 – 8
Secondary/protocol endpoint

Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382

Time frame:Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14

Tmax

descriptive

Posted result

GroupValue (median), Hours95% CI
MEDI0382 Cohort 2Day 184 – 12
Day 760 – 8
Day 1464 – 12
Secondary/protocol endpoint

Cohort 1: Terminal Half Life (t1/2) of MEDI0382

Time frame:Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49

Half-life

descriptive

Posted result

GroupValue (geometric_mean), Hours95% CI
MEDI0382 Cohort 1Day 229.679.67 – 9.67
Day 498.47.7 – 9.4
Secondary/protocol endpoint

Cohort 2: Terminal Half Life (t1/2) of MEDI0382

Time frame:Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14

Half-life

descriptive

Posted result

GroupValue (geometric_mean), Hours95% CI
MEDI0382 Cohort 2Day 19.78.9 – 10.2
Day 78.88.6 – 9.0
Day 149.48.7 – 10.5
Secondary/protocol endpoint

Cohort 1: Accumulation Ratio (Racc) of MEDI0382

Time frame:Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49

AUC₀–∞

ratio, descriptive

Posted result

GroupValue (geometric_mean), Ratio95% CI
MEDI0382 Cohort 11.461.13 – 2.98
Secondary/protocol endpoint

Cohort 2: Accumulation Ratio of MEDI0382

Time frame:Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14

ratio, descriptive

Posted result

GroupValue (geometric_mean), Ratio95% CI
MEDI0382 Cohort 2Day 71.361.2 – 1.6
Day 141.461.2 – 1.9
Secondary/protocol endpoint

Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382

Time frame:Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI0382 Cohort 1Day 223.5660.50 – 9.27
Day 495.7621.53 – 11.80
Secondary/protocol endpoint

Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382

Time frame:Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
MEDI0382 Cohort 2Day 71.1470.79 – 2.36
Day 141.1470.69 – 1.92
Secondary/protocol endpoint

Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382

Time frame:Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo Cohort 1Baseline (ADA positive)0
Day 29 (ADA positive)0
Day 50 (ADA positive)0
Follow-up Visit 2 (ADA positive)1
MEDI0382 Cohort 1Baseline (ADA positive)0
Day 29 (ADA positive)4
Day 50 (ADA positive)7
Follow-up Visit 2 (ADA positive)6
Placebo Cohort 2Baseline (ADA positive)0
Day 29 (ADA positive)0
Day 50 (ADA positive)0
Follow-up Visit 2 (ADA positive)0
MEDI0382 Cohort 2Baseline (ADA positive)0
Day 29 (ADA positive)1
Day 50 (ADA positive)2
Follow-up Visit 2 (ADA positive)6

Publications (1)

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.