GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes

A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Lead sponsor

AstraZeneca

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 24-40•HbA1c 7-10.5%

Primary endpoints

•Heart rate, change•24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48 (Systolic BP, change, Diastolic BP, change)•Postprandial glucose

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 IDNCT03645421

Org study IDD5674C00001

Timeline

Milestones

Study start2018-08-10actual

Study first posted2018-08-24actual

Primary completion2019-01-17actual

Study completion2019-01-17actual

Last update posted2019-12-23actual

Results first posted2019-12-23actual

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age120 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.

•Individuals who are diagnosed with T2DM

•Individuals whose current condition at enrolment (Visit 1) is drug naïve

•BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

Exclusion criteria

•Subjects with any of the following results at screening:

•Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)

•Alanine transaminase (ALT) ≥ 2.5 × ULN

•Total bilirubin (TBL) ≥ 2 × ULN

•Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 at screening

•Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening

Endpoints (15)

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

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Primary/protocol endpoint

Mean Percentage Change From Baseline in Body Weight at Day 48

Time frame:Baseline (Day -1) and Day 48.

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage change	95% CI
Placebo	-0.82	-2.06 – 0.43
MEDI0382 100 mcg	-2.12	-3.40 – -0.84
MEDI0382 200 mcg	-3.34	-4.68 – -2.01
MEDI0382 300 mcg	-3.34	-4.61 – -2.06

LS mean difference-1.3095% CI-3.08 – 0.47p0.1476ANCOVA

Pair-wise comparison of MEDI0382 100 mcg versus Placebo.

LS mean difference-2.5395% CI-4.37 – -0.69p0.0080ANCOVA

Pair-wise comparison of MEDI0382 200 mcg versus Placebo.

LS mean difference-2.5295% CI-4.30 – -0.74p0.0063ANCOVA

Pair-wise comparison of MEDI0382 300 mcg versus Placebo.

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48

Time frame:Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.

Postprandial glucose

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage change	95% CI
Placebo	2.45	-3.37 – 8.26
MEDI0382 100 mcg	-39.66	-45.67 – -33.66
MEDI0382 200 mcg	-31.16	-38.61 – -23.71
MEDI0382 300 mcg	-37.86	-44.95 – -30.76

Least squares (LS) mean difference-42.1195% CI-50.47 – -33.75p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 100 mcg versus Placebo.

LS mean difference-33.6195% CI-43.04 – -24.18p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 200 mcg versus Placebo.

LS mean difference-40.3095% CI-49.49 – -31.12p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 300 mcg versus Placebo.

Secondary/protocol endpoint

Mean Change From Baseline in HbA1c at Day 48

Time frame:Baseline (Day -1) and Day 48 (predose).

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent glycated haemoglobin	95% CI
Placebo	-0.14	-0.41 – 0.12
MEDI0382 100 mcg	-1.23	-1.51 – -0.96
MEDI0382 200 mcg	-1.24	-1.53 – -0.96
MEDI0382 300 mcg	-0.90	-1.18 – -0.63

LS mean difference-1.0995% CI-1.48 – -0.70p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 100 mcg versus Placebo.

LS mean difference-1.1095% CI-1.49 – -0.71p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 200 mcg versus Placebo.

LS mean difference-0.7695% CI-1.15 – -0.38p0.0002ANCOVA

Pair-wise comparison of MEDI0382 300 mcg versus Placebo.

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose at Day 48

Time frame:Baseline (Day -1) and Day 48 (predose).

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per decilitre (mg/dL)	95% CI
Placebo	-0.40	-12.60 – 11.80
MEDI0382 100 mcg	-57.10	-69.77 – -44.42
MEDI0382 200 mcg	-60.98	-76.82 – -45.15
MEDI0382 300 mcg	-55.47	-70.28 – -40.66

LS mean difference-56.6995% CI-74.30 – -39.09p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 100 mcg versus Placebo.

LS mean difference-60.5895% CI-80.53 – -40.63p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 200 mcg versus Placebo.

LS mean difference-55.0795% CI-74.28 – -35.86p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 300 mcg versus Placebo.

Secondary/protocol endpoint

Mean Change From Baseline in Fructosamine at Day 48

Time frame:Baseline (Day -1) and Day 48 (predose).

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimoles per litre (mmol/L)	95% CI
Placebo	-0.012	-0.029 – 0.004
MEDI0382 100 mcg	-0.083	-0.100 – -0.066
MEDI0382 200 mcg	-0.066	-0.083 – -0.048
MEDI0382 300 mcg	-0.061	-0.079 – -0.044

LS mean difference-0.07195% CI-0.094 – -0.047p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 100 mcg versus Placebo.

LS mean difference-0.05395% CI-0.077 – -0.030p<0.0001ANCOVA

Pair-wise comparison of MEDI0382 200 mcg versus Placebo.

LS mean difference-0.04995% CI-0.074 – -0.024p0.0002ANCOVA

Pair-wise comparison of MEDI0382 300 mcg versus Placebo.

Secondary/protocol endpoint

Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47

Time frame:Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.

CGM time-above-range

change from baseline, improvement

Posted result

Group	Value (mean), Percentage of time	95% CI
PlaceboDay 5	-3.23	—
Day 12	-11.72	—
Day 19	-12.08	—
Day 47	-6.15	—
MEDI0382 100 mcgDay 5	-48.35	—
Day 12	-57.74	—
Day 19	-59.57	—
Day 47	-47.99	—
MEDI0382 200 mcgDay 5	-33.71	—
Day 12	-53.36	—
Day 19	-43.85	—
Day 47	-48.96	—
MEDI0382 300 mcgDay 5	-51.33	—
Day 12	-55.78	—
Day 19	-60.68	—
Day 47	-57.59	—

Secondary/protocol endpoint

Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47

Time frame:Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.

CGM time-below-range

change from baseline, improvement

Posted result

Group	Value (mean), Percentage of time	95% CI
PlaceboDay 5	0.00	—
Day 12	0.00	—
Day 19	0.00	—
Day 47	0.00	—
MEDI0382 100 mcgDay 5	0.00	—
Day 12	0.00	—
Day 19	0.00	—
Day 47	0.00	—
MEDI0382 200 mcgDay 5	0.00	—
Day 12	0.00	—
Day 19	3.68	—
Day 47	0.00	—
MEDI0382 300 mcgDay 5	6.28	—
Day 12	0.00	—
Day 19	0.00	—
Day 47	0.00	—

Secondary/protocol endpoint

Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels

Time frame:Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.

CGM time-above-range

change from baseline, improvement

Posted result

Group	Value (mean), Percentage of time	95% CI
PlaceboDays 1 to 5	-1.43	—
Days 6 to 12	-8.97	—
Days 13 to 19	-6.09	—
Days 41 to 47	-0.40	—
MEDI0382 100 mcgDays 1 to 5	-42.52	—
Days 6 to 12	-48.35	—
Days 13 to 19	-53.25	—
Days 41 to 47	-42.37	—
MEDI0382 200 mcgDays 1 to 5	-38.68	—
Days 6 to 12	-50.81	—
Days 13 to 19	-52.33	—
Days 41 to 47	-43.44	—
MEDI0382 300 mcgDays 1 to 5	-34.74	—
Days 6 to 12	-51.82	—
Days 13 to 19	-47.50	—
Days 41 to 47	-51.25	—

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48

Time frame:Baseline (Day -1) and Days 20 and 48.

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/minute	95% CI
PlaceboDay 20	-1.86	—
Day 48	-0.25	—
MEDI0382 100 mcgDay 20	6.65	—
Day 48	7.87	—
MEDI0382 200 mcgDay 20	13.50	—
Day 48	12.81	—
MEDI0382 300 mcgDay 20	15.80	—
Day 48	15.22	—

Primary/protocol endpoint

Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48

Time frame:Baseline (Day -1) and Days 20 and 48.

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), millimetres of mercury	95% CI
Placebo24-hour Systolic BP: Day 20	2.98	—
24-hour Systolic BP: Day 48	0.08	—
24-hour Diastolic BP: Day 20	0.98	—
24-hour Diastolic BP: Day 48	-0.06	—
MEDI0382 100 mcg24-hour Systolic BP: Day 20	-4.09	—
24-hour Systolic BP: Day 48	-2.27	—
24-hour Diastolic BP: Day 20	-0.62	—
24-hour Diastolic BP: Day 48	-0.66	—
MEDI0382 200 mcg24-hour Systolic BP: Day 20	-7.24	—
24-hour Systolic BP: Day 48	-5.17	—
24-hour Diastolic BP: Day 20	-1.41	—
24-hour Diastolic BP: Day 48	-0.27	—
MEDI0382 300 mcg24-hour Systolic BP: Day 20	-2.48	—
24-hour Systolic BP: Day 48	-6.97	—
24-hour Diastolic BP: Day 20	0.81	—
24-hour Diastolic BP: Day 48	-0.68	—

Primary/protocol endpoint

Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.

Time frame:Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/minute	95% CI
PlaceboDay 1: 6 hours postdose	1.77	—
Day 6: predose	-2.85	—
Day 6: 6 hours postdose	0.02	—
Day 13: predose	-2.63	—
Day 13: 6 hours postdose	2.19	—
Day 20: predose	-1.85	—
Day 20: 6 hours postdose	0.29	—
Day 48: predose	-1.06	—
Day 48: 6 hours postdose	-6.25	—
MEDI0382 100 mcgDay 1: 6 hours postdose	4.24	—
Day 6: predose	1.84	—
Day 6: 6 hours postdose	4.62	—
Day 13: predose	6.91	—
Day 13: 6 hours postdose	6.40	—
Day 20: predose	6.24	—
Day 20: 6 hours postdose	5.09	—
Day 48: predose	7.20	—
Day 48: 6 hours postdose	1.16	—
MEDI0382 200 mcgDay 1: 6 hours postdose	2.18	—
Day 6: predose	7.69	—
Day 6: 6 hours postdose	8.88	—
Day 13: predose	8.93	—
Day 13: 6 hours postdose	16.62	—
Day 20: predose	11.97	—
Day 20: 6 hours postdose	16.79	—
Day 48: predose	10.20	—
Day 48: 6 hours postdose	15.43	—
MEDI0382 300 mcgDay 1: 6 hours postdose	6.27	—
Day 6: predose	10.79	—
Day 6: 6 hours postdose	10.67	—
Day 13: predose	11.74	—
Day 13: 6 hours postdose	13.31	—
Day 20: predose	13.03	—
Day 20: 6 hours postdose	16.94	—
Day 48: predose	17.06	—
Day 48: 6 hours postdose	12.70	—

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Patients Who Experienced Adverse Events (AEs)

Time frame:Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
PlaceboAny AE	6	—
Any SAE	0	—
Any AE leading to discontinuation of IP	0	—
MEDI0382 100 mcgAny AE	6	—
Any SAE	0	—
Any AE leading to discontinuation of IP	0	—
MEDI0382 200 mcgAny AE	11	—
Any SAE	0	—
Any AE leading to discontinuation of IP	4	—
MEDI0382 300 mcgAny AE	9	—
Any SAE	0	—
Any AE leading to discontinuation of IP	1	—

Secondary/protocol endpoint

Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels

Time frame:Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.

Documented hypoglycemia

change from baseline, event

Posted result

Group	Value (mean), Percentage of time	95% CI
PlaceboDays 1 to 5	0.21	—
Days 6 to 12	0.06	—
Days 13 to 19	0.10	—
Days 41 to 47	0.01	—
MEDI0382 100 mcgDays 1 to 5	0.06	—
Days 6 to 12	0.90	—
Days 13 to 19	0.41	—
Days 41 to 47	-0.02	—
MEDI0382 200 mcgDays 1 to 5	0.25	—
Days 6 to 12	0.07	—
Days 13 to 19	2.97	—
Days 41 to 47	0.30	—
MEDI0382 300 mcgDays 1 to 5	5.50	—
Days 6 to 12	0.13	—
Days 13 to 19	1.09	—
Days 41 to 47	2.59	—

Secondary/protocol endpoint

Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48

Time frame:Blood samples collected predose on Days 1 to 6, 13, 20, 34 and 48.

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms per millilitre	95% CI
MEDI0382 100 mcgDay 2	1.20	—
Day 5	1.47	—
Day 34	2.70	—
Day 48	2.83	—
MEDI0382 200 mcgDay 2	1.22	—
Day 5	1.61	—
Day 34	5.16	—
Day 48	7.14	—
MEDI0382 300 mcgDay 2	1.11	—
Day 5	1.56	—
Day 34	7.18	—
Day 48	9.12	—

Secondary/protocol endpoint

Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382

Time frame:Samples were collected predose on days 1, 13, 20 and 48, and 7 to 14 days after administration of last dose of IP.

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
MEDI0382 100 mcgADA +ve at baseline	0	—
ADA +ve post-baseline	4	—
ADA +ve post-baseline & +ve at baseline	0	—
ADA+ve post-baseline & not detected at baseline	4	—
Persistent +ve	2	—
Transient +ve	2	—
ADA not detected post-baseline & +ve baseline	0	—
MEDI0382 200 mcgADA +ve at baseline	0	—
ADA +ve post-baseline	5	—
ADA +ve post-baseline & +ve at baseline	0	—
ADA+ve post-baseline & not detected at baseline	5	—
Persistent +ve	4	—
Transient +ve	1	—
ADA not detected post-baseline & +ve baseline	0	—
MEDI0382 300 mcgADA +ve at baseline	0	—
ADA +ve post-baseline	2	—
ADA +ve post-baseline & +ve at baseline	0	—
ADA+ve post-baseline & not detected at baseline	2	—
Persistent +ve	2	—
Transient +ve	0	—
ADA not detected post-baseline & +ve baseline	0	—

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.