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CompletedPhase 2Results posted

A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus

An Exploratory Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

28

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 28-40HbA1c ≤8%

Primary endpoint

Body 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 IDNCT03596177
Org study IDD5670C00021

Timeline

Milestones

Study first posted2018-07-23actual
Study start2018-09-26actual
Primary completion2019-12-22actual
Study completion2019-12-22actual
Results first posted2021-01-15actual
Last update posted2023-01-19actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Participants aged >= 30 and <= 75 years at screening

2. Provision of signed and dated written informed consent (except for consent for genetic and non-genetic research and additional optional assessments) prior to any protocol-related procedures

3. Body Mass Index > 28 and <= 40 kg/m^2 at screening

4. Glycated haemoglobin (HbA1c) <= 8.0% at screening

5. Diagnosed with type 2 diabetes (T2DM) with glucose control managed with metformin, with or without a dipeptidyl peptidase 4 (DPPIV) inhibitor, Sodium-glucose co-transporter-2 inhibitors (SGLT2i), sulfonylurea, or meglitinide, where no significant dose change (increase or decrease > 50%) has occurred in the 3 months prior to screening; if the participant is on dual therapy, a 4-week washout of the non-metformin therapy (DPPIV inhibitor, SGLT2i, sulfonylurea, or meglitinide) will be required prior to Visit 4.

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

7. Female participants of childbearing potential who are sexually active with a non-sterilised male partner must be using at least one highly effective method of contraception from screening and must agree to continue using such precautions up until 4 weeks after the last dose of study drug

Exclusion criteria

1. History of, or any existing condition(s) 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

2. Any participant with a cardiac pacemaker or implanted/portable electronic device

3. 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 (Visit 1)

4. Any participant who has received any of the following medications within the specified timeframe prior to Visit 2: herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion, naltrexone, phentermine-topiramate, phentermine, lorcaserin, opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying)

5. Concurrent participation in another study with a study drug and prior randomisation in this study is prohibited

6. Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, or standardised meals

7. 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.

8. Abnormal thyroid stimulating hormone (TSH) level of < 0.03 Milli-International Units Per Litre (mIU/L) or > 10 mIU/L confirmed on two consecutive tests

9. Regularly engage in high intensity exercise at least three times per week or have done so in the prior three months

10. Clinically 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

11. Acute or chronic pancreatitis

12. Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:

1. Aspartate transaminase (AST) >= 3 × upper limit of normal (ULN)

2. Alanine transaminase (ALT) >= 3 × ULN

3. Total bilirubin >= 2 × ULN

13. Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 45 mL/minute/1.73 m^2 at screening (GFR estimated according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or the Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation isotope dilution mass spectrometry-traceable [International System of Units (SI) units]

14. Poorly controlled hypertension defined as:

1. Systolic blood pressure (BP) > 180 mm Hg

2. Diastolic BP or > 100 mm Hg After 10 minutes of supine rest and confirmed by repeated measurement at screening.

Participants who fail BP screening criteria may be considered for 24-hour ambulatory BP monitoring at the discretion of the investigator. Participants who maintain a mean 24-hour BP <= 180/100 mmHg with a preserved nocturnal dip of > 15% will be considered eligible

15. 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

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

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

18. 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

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

20. Substance dependence or history of alcohol abuse and/or excess alcohol intake

21. Involvement of any AstraZeneca, Medimmune Ltd, contract research organization (CRO), or National Institute for Health Research/Wellcome Trust Cambridge Clinical Research Facility employee or their close relatives

Endpoints (23)

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
9
Cardiometabolic biomarkers
5
Safety / tolerability / PK
5
Glycemic / diabetes
2
Other clinical outcomes
2

Weight & body composition

9 endpoints
Primary/protocol endpoint

Percent Change in Body Weight From Baseline to Day 59

Time frame:Baseline (Day 17) and Day 59

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in body weight95% CI
Placebo-1.40-2.66 – -0.13
MEDI0382-3.98-4.85 – -3.10
Mean Difference (Net)-2.5890% CI-4.15-1.00p0.011ANCOVA
Secondary/protocol endpoint

Change in TEE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

Time frame:Baseline (Day 15) and Day 58

TEE whole room calorimetry

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), kilojoules/kg fat body mass95% CI
Placebo5.969-8.364 – 20.302
MEDI0382-4.070-14.924 – 6.783
Mean Difference (Net)-10.03990% CI-28.2878.209p0.351ANCOVA
Secondary/protocol endpoint

Percent Change in Activity Energy Expenditure (AEE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

Time frame:Baseline (Day 15) and Day 58

AEE

percent change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), Percent change in AEE95% CI
Placebo-0.446-6.836 – 5.943
MEDI0382-0.261-5.139 – 4.618
Mean Difference (Net)0.18690% CI-7.8588.229p0.968ANCOVA
Secondary/protocol endpoint

Percent Change in Resting Energy Expenditure (REE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

Time frame:Baseline (Day 15) and Day 58

REE

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in REE95% CI
Placebo8.1133.254 – 12.972
MEDI03824.4680.816 – 8.120
Mean Difference (Net)-3.64590% CI-9.8942.603p0.324ANCOVA
Secondary/protocol endpoint

Change in Body Weight From Baseline to Day 59

Time frame:Baseline (Day 17) and Day 59

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-1.26-2.48 – -0.05
MEDI0382-3.80-4.65 – -2.96
Mean Difference (Net)-2.5490% CI-4.05-1.03p0.009ANCOVA
Secondary/protocol endpoint

Percent Change in Total Body Fat Mass as Measured by Dual-energy X-ray Absorptiometry (DXA) From Baseline to Day 59

Time frame:Baseline (Day -1) and Day 59

Total fat mass

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in total body fat mass95% CI
Placebo-4.218-8.249 – -0.186
MEDI0382-9.340-12.343 – -6.337
Mean Difference (Net)-5.12290% CI-10.3640.119p0.107ANCOVA
Secondary/protocol endpoint

Change in Total Body Fat Mass as Measured by DXA From Baseline to Day 59

Time frame:Baseline (Day -1) and Day 59

Total fat mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Kg95% CI
Placebo-1.455-2.806 – -0.103
MEDI0382-3.303-4.310 – -2.296
Mean Difference (Net)-1.84890% CI-3.605-0.091p0.085ANCOVA
Secondary/protocol endpoint

Percent Change in Total Body Fat Mass: Lean Mass Ratio as Measured by DXA From Baseline to Day 59

Time frame:Baseline (Day -1) and Day 59

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in TBFM:LM ratio95% CI
Placebo-1.667-4.934 – 1.600
MEDI0382-4.827-7.298 – -2.355
Mean Difference (Net)-3.15990% CI-7.3261.007p0.204ANCOVA
Secondary/protocol endpoint

Change in Total Body Fat Mass: Lean Mass Ratio as Measured by DXA From Baseline to Day 59

Time frame:Baseline (Day -1) and Day 59

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Ratio95% CI
Placebo-0.010-0.027 – 0.007
MEDI0382-0.029-0.042 – -0.016
Mean Difference (Net)-0.01990% CI-0.0410.003p0.145ANCOVA

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in Fasting Glucose During a Mixed-meal Tolerance Test (MMTT) From Baseline to Day 59

Time frame:Baseline (Day -1) and Day 59

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), mg/dL95% CI
Placebo-12.600-21.673 – -3.527
MEDI0382-38.601-45.360 – -31.842
Mean Difference (Net)-26.00190% CI-37.801-14.201p0.001ANCOVA
Secondary/protocol endpoint

Percent Change in Glucose Area Under the Concentration-time Curve at 0 to 4 Hours (AUC0-4hrs) During a MMTT From Baseline to Day 59

Time frame:Baseline (Day -1) and Day 59

Postprandial glucose

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percentage change in glucose AUC0-4hrs95% CI
Placebo-6.773-12.528 – -1.018
MEDI0382-19.105-23.434 – -14.777
Mean Difference (Net)-12.33290% CI-19.726-4.938p0.010ANCOVA

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Percent Change in Total Energy Expenditure (TEE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

Time frame:Baseline (Day 15) and Day 58

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in TEE95% CI
Placebo2.032-2.833 – 6.898
MEDI0382-1.141-4.825 – 2.544
Mean Difference (Net)-3.17390% CI-9.3683.022p0.384ANCOVA
Secondary/protocol endpoint

Change in AEE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

Time frame:Baseline (Day 15) and Day 58

AEE whole room calorimetry

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilojoules/kg fat body mass95% CI
Placebo-1.132-3.259 – 0.995
MEDI0382-0.265-1.889 – 1.359
Mean Difference (Net)0.86790% CI-1.8103.545p0.580ANCOVA
Secondary/protocol endpoint

Change in REE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

Time frame:Baseline (Day 15) and Day 58

percent change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), kilojoules/kg fat body mass95% CI
Placebo13.2374.104 – 22.369
MEDI03827.5650.701 – 14.429
Mean Difference (Net)-5.67290% CI-17.4156.072p0.412ANCOVA
Secondary/protocol endpoint

Percent Change in REE as Measured by Hood Indirect Calorimetry From Baseline to Day 32

Time frame:Baseline (Day 16) and Day 32

REE hood indirect calorimetry

percent change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), Percent Change in REE95% CI
Placebo1.189-5.955 – 8.332
MEDI03828.5463.138 – 13.954
Mean Difference (Net)7.35790% CI-1.74216.456p0.177ANCOVA
Secondary/protocol endpoint

Change in REE as Measured by Hood Indirect Calorimetry From Baseline to Day 32

Time frame:Baseline (Day 16) and Day 32

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), kilojoules/kg fat body mass95% CI
Placebo3.316-11.080 – 17.712
MEDI038218.5027.604 – 29.400
Mean Difference (Net)15.18690% CI-3.15133.523p0.168ANCOVA

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

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

Time frame:Day 17 through 28 days post last dose (approximately 14 months)

Treatment-emergent AEs (any)

event count, event

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

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboAny TEAEs5
Any TESAEs0
MEDI0382Any TEAEs17
Any TESAEs2
Secondary/protocol endpoint

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

Time frame:Day 17 through 28 days post last dose (approximately 14 months)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo0
MEDI03820
Secondary/protocol endpoint

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Time frame:Day 17 through 28 days post last dose (approximately 14 months)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo0
MEDI03820
Secondary/protocol endpoint

Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs

Time frame:Day 17 through 28 days post last dose (approximately 14 months)

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo0
MEDI03824
Secondary/protocol endpoint

Number of Participants With Positive Anti-drug Antibodies (ADAs) to MEDI0382

Time frame:Day 17 (predose), Day 32 (predose), Day 59; and 28 days post last dose (approximately 14 months)

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboADA positive post-BL0
Treatment-boosted ADA0
Treatment-emergent ADA0
MEDI0382ADA positive post-BL3
Treatment-boosted ADA0
Treatment-emergent ADA3

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Percent Change in Total Energy Intake From the ad Libitum Lunch From Baseline to Day 32 and Day 59

Time frame:Baseline (Day 16), Day 32, and Day 59

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change in total energy intake95% CI
PlaceboPercent change at Day 32-5.170-23.344 – 13.003
Percent change at Day 59-10.598-31.316 – 10.119
MEDI0382Percent change at Day 32-50.652-63.480 – -37.823
Percent change at Day 59-51.922-66.546 – -37.297
Mean Difference (Net)-45.48190% CI-67.777-23.186p0.002ANCOVA

Statistical Analysis for Day 32

Mean Difference (Net)-41.32390% CI-66.740-15.907p0.011ANCOVA

Statistical Analysis for Day 59

Secondary/protocol endpoint

Change in Total Energy Intake From the ad Libitum Lunch From Baseline to Day 32 and Day 59

Time frame:Baseline (Day 16) to Day 32 and Day 59

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Kilojoules95% CI
PlaceboChange at Day 32-126.271-647.387 – 394.846
Change at Day 59-410.816-1107.896 – 286.263
MEDI0382Change at Day 32-1677.465-2045.322 – -1309.607
Change at Day 59-1743.331-2235.400 – -1251.261
Mean Difference (Net)-1551.19490% CI-2190.515-911.873p<0.001ANCOVA

Statistical Analysis for Day 32

Mean Difference (Net)-1332.51590% CI-2187.711-477.318p0.015ANCOVA

Statistical Analysis for Day 59

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.

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.