GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Assets

Cotadutide / Liraglutide

Listed sites

119

Recruiting sites

—

Enrollment

834

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7-10.5%

Primary endpoints

•HbA1c, change•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 IDNCT03235050

Org study IDD5670C00004

Timeline

Milestones

Study first posted2017-08-01actual

Study start2017-08-02actual

Primary completion2018-05-03actual

Study completion2019-06-14actual

Results first posted2020-07-20actual

Last update posted2020-08-17actual

Assets

Investigational agents

Cotadutide Liraglutide

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

•Provision of informed consent

•Male and female subjects aged ≥ 18 years at screening

•Body mass index ≥ 25 kg/m2 at screening

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

•Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable

•Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP

Exclusion criteria

•History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, 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

•Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening

•Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

•Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening

•Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening

•Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract

•Significant hepatic disease

•Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening

•Severely uncontrolled hypertension

•Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening

•Severe congestive heart failure

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

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

12 endpoints

Primary/registry result

Percent Change in Body Weight

Time frame:From baseline to 14 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Placebo	-0.70	-1.44 – 0.04
MEDI0382 100 mcg	-2.70	-3.49 – -1.91
MEDI0382 200 mcg	-3.47	-3.95 – -2.98
MEDI0382 300 mcg	-4.33	-4.82 – -3.84

LS Mean Difference-2.0095% CI-3.08 – -0.91p<0.001ANCOVA

LS Mean Difference-2.7695% CI-3.65 – -1.87p<0.001ANCOVA

LS Mean Difference-3.6295% CI-4.51 – -2.73p<0.001ANCOVA

Primary/protocol endpoint

Percent Change in Body Weight

Time frame:From baseline to 14 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percent Change in Body Weight

Time frame:from baseline to 26 weeks and 54 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Placebofrom baseline to 26 weeks	-1.14	-1.99 – -0.29
from baseline to 54 weeks	-0.84	-1.82 – 0.14
MEDI0382 100 mcgfrom baseline to 26 weeks	-3.23	-4.13 – -2.32
from baseline to 54 weeks	-3.27	-4.32 – -2.22
MEDI0382 200 mcgfrom baseline to 26 weeks	-3.94	-4.51 – -3.38
from baseline to 54 weeks	-3.08	-3.73 – -2.43
MEDI0382 300 mcgfrom baseline to 26 weeks	-4.60	-5.17 – -4.04
from baseline to 54 weeks	-4.16	-4.81 – -3.50

LS Mean Difference-2.0995% CI-3.32 – -0.85p<0.001ANCOVA

Week 26

LS Mean Difference-2.8095% CI-3.82 – -1.79p<0.001ANCOVA

Week 26

LS Mean Difference-3.4695% CI-4.48 – -2.44p<0.001ANCOVA

Week 26

LS Mean Difference-2.4395% CI-3.86 – -1.00p<0.001ANCOVA

Week 54

LS Mean Difference-2.2495% CI-3.41 – -1.06p<0.001ANCOVA

Week 54

LS Mean Difference-3.3295% CI-4.49 – -2.14p<0.001ANCOVA

Week 54

Secondary/registry result

Absolute Change in Body Weight

Time frame:from baseline to 14 weeks, 26 weeks and 54 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Placebofrom baseline to 14 weeks	-0.71	-1.44 – 0.03
from baseline to 26 weeks	-1.20	-2.06 – -0.34
from baseline to 54 weeks	-0.94	-1.94 – 0.07
MEDI0382 100 mcgfrom baseline to 14 weeks	-2.66	-3.45 – -1.87
from baseline to 26 weeks	-3.20	-4.13 – -2.28
from baseline to 54 weeks	-3.20	-4.28 – -2.12
MEDI0382 200 mcgfrom baseline to 14 weeks	-3.45	-3.94 – -2.97
from baseline to 26 weeks	-3.94	-4.52 – -3.37
from baseline to 54 weeks	-3.09	-3.77 – -2.42
MEDI0382 300 mcgfrom baseline to 14 weeks	-4.42	-4.91 – -3.93
from baseline to 26 weeks	-4.75	-5.33 – -4.18
from baseline to 54 weeks	-4.35	-5.03 – -3.68

LS Mean Difference-1.9595% CI-3.03 – -0.87p<0.001ANCOVA

Week 14

LS Mean Difference-2.7595% CI-3.63 – -1.86p<0.001ANCOVA

Week 14

LS Mean Difference-3.7195% CI-4.60 – -2.82p<0.001ANCOVA

Week 14

LS Mean Difference-2.0195% CI-3.27 – -0.74p0.002ANCOVA

Week 26

LS Mean Difference-2.7495% CI-3.78 – -1.71p<0.001ANCOVA

Week 26

LS Mean Difference-3.5595% CI-4.59 – -2.52p<0.001ANCOVA

Week 26

LS Mean Difference-2.2795% CI-3.74 – -0.79p0.003ANCOVA

Week 54

LS Mean Difference-2.1695% CI-3.37 – -0.95p<0.001ANCOVA

Week 54

LS Mean Difference-3.4295% CI-4.63 – -2.20p<0.001ANCOVA

Week 54

Secondary/registry result

Percent Change in Body Weight Versus Active Comparator

Time frame:from baseline to 14 weeks, 26 weeks and 54 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
LiraglutidePercent change at 14 weeks	-3.40	-4.14 – -2.65
Percent change at 26 weeks	-4.12	-4.98 – -3.27
Percent change at 54 weeks	-3.20	-4.19 – -2.21
MEDI0382 100 mcgPercent change at 14 weeks	-2.70	-3.49 – -1.91
Percent change at 26 weeks	-3.23	-4.13 – -2.32
Percent change at 54 weeks	-3.27	-4.32 – -2.22
MEDI0382 200 mcgPercent change at 14 weeks	-3.47	-3.95 – -2.98
Percent change at 26 weeks	-3.94	-4.51 – -3.38
Percent change at 54 weeks	-3.08	-3.73 – -2.43
MEDI0382 300 mcgPercent change at 14 weeks	-4.33	-4.82 – -3.84
Percent change at 26 weeks	-4.60	-5.17 – -4.04
Percent change at 54 weeks	-4.16	-4.81 – -3.50

LS Mean Difference0.7095% CI-0.39 – 1.79p0.211ANCOVA

Percent change at Week 14

LS Mean Difference-0.0795% CI-0.96 – 0.83p0.881ANCOVA

Percent change at Week 14

LS Mean Difference-0.9395% CI-1.82 – -0.04p0.042ANCOVA

Percent change at Week 14

LS Mean Difference0.9095% CI-0.35 – 2.14p0.158ANCOVA

Percent change at Week 26

LS Mean Difference0.1895% CI-0.85 – 1.20p0.734ANCOVA

Percent change at Week 26

LS Mean Difference-0.4895% CI-1.51 – 0.54p0.357ANCOVA

Percent change at Week 26

LS Mean Difference-0.0795% CI-1.51 – 1.37p0.921ANCOVA

Percent change at Week 54

LS Mean Difference0.1295% CI-1.07 – 1.30p0.847ANCOVA

Percent change at Week 54

LS Mean Difference-0.9695% CI-2.15 – 0.22p0.112ANCOVA

Percent change at Week 54

Secondary/registry result

Absolute Change in Body Weight Versus Active Comparator

Time frame:from baseline to 14 weeks, 26 weeks and 54 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
LiraglutideAbsolute change at 14 weeks	-3.25	-4.00 – -2.51
Absolute change at 26 weeks	-3.90	-4.77 – -3.03
Absolute change at 54 weeks	-2.94	-3.96 – -1.92
MEDI0382 100 mcgAbsolute change at 14 weeks	-2.66	-3.45 – -1.87
Absolute change at 26 weeks	-3.20	-4.13 – -2.28
Absolute change at 54 weeks	-3.20	-4.28 – -2.12
MEDI0382 200 mcgAbsolute change at 14 weeks	-3.45	-3.94 – -2.97
Absolute change at 26 weeks	-3.94	-4.52 – -3.37
Absolute change at 54 weeks	-3.09	-3.77 – -2.42
MEDI0382 300 mcgAbsolute change at 14 weeks	-4.42	-4.91 – -3.93
Absolute change at 26 weeks	-4.75	-5.33 – -4.18
Absolute change at 54 weeks	-4.35	-5.03 – -3.68

LS Mean Difference0.5995% CI-0.49 – 1.68p0.284ANCOVA

Absolute change at Week 14

LS Mean Difference-0.2095% CI-1.09 – 0.69p0.658ANCOVA

Absolute change at Week 14

LS Mean Difference-1.1795% CI-2.06 – -0.27p0.010ANCOVA

Absolute change at Week 14

LS Mean Difference0.7095% CI-0.57 – 1.97p0.279ANCOVA

Absolute change at Week 26

LS Mean Difference-0.0495% CI-1.08 – 1.00p0.940ANCOVA

Absolute change at Week 26

LS Mean Difference-0.8595% CI-1.89 – 0.19p0.110ANCOVA

Absolute change at Week 26

LS Mean Difference-0.2695% CI-1.74 – 1.22p0.730ANCOVA

Absolute change at Week 54

LS Mean Difference-0.1595% CI-1.38 – 1.07p0.804ANCOVA

Absolute change at Week 54

LS Mean Difference-1.4195% CI-2.63 – -0.19p0.023ANCOVA

Absolute change at Week 54

Secondary/registry result

Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%

Time frame:after 14 weeks, 26 weeks and 54 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
PlaceboParticipants with weight loss ≥5% at Wk 14 (LOCF)	3	—
Participants with weight loss ≥5% at Wk 26 (LOCF)	11	—
Participants with weight loss ≥5% at Wk 54 (LOCF)	14	—
Participants with weight loss ≥10% at Wk 14 (LOCF)	0	—
Participants with weight loss ≥10% at Wk 26 (LOCF)	1	—
Participants with weight loss ≥10% at Wk 54 (LOCF)	2	—
MEDI0382 100 mcgParticipants with weight loss ≥5% at Wk 14 (LOCF)	18	—
Participants with weight loss ≥5% at Wk 26 (LOCF)	28	—
Participants with weight loss ≥5% at Wk 54 (LOCF)	34	—
Participants with weight loss ≥10% at Wk 14 (LOCF)	6	—
Participants with weight loss ≥10% at Wk 26 (LOCF)	7	—
Participants with weight loss ≥10% at Wk 54 (LOCF)	11	—
MEDI0382 200 mcgParticipants with weight loss ≥5% at Wk 14 (LOCF)	65	—
Participants with weight loss ≥5% at Wk 26 (LOCF)	76	—
Participants with weight loss ≥5% at Wk 54 (LOCF)	71	—
Participants with weight loss ≥10% at Wk 14 (LOCF)	15	—
Participants with weight loss ≥10% at Wk 26 (LOCF)	28	—
Participants with weight loss ≥10% at Wk 54 (LOCF)	21	—
MEDI0382 300 mcgParticipants with weight loss ≥5% at Wk 14 (LOCF)	92	—
Participants with weight loss ≥5% at Wk 26 (LOCF)	110	—
Participants with weight loss ≥5% at Wk 54 (LOCF)	98	—
Participants with weight loss ≥10% at Wk 14 (LOCF)	20	—
Participants with weight loss ≥10% at Wk 26 (LOCF)	27	—
Participants with weight loss ≥10% at Wk 54 (LOCF)	32	—

Odds Ratio, log8.3795% CI2.38 – 29.43p<0.001Regression, Logistic

weight loss \>=5% at Week 14

Odds Ratio, log12.4695% CI3.82 – 40.64p<0.001Regression, Logistic

weight loss \>=5% at Week 14

Odds Ratio, log21.2695% CI6.55 – 68.97p<0.001Regression, Logistic

weight loss \>=5% at Week 14

Odds Ratio, log3.6895% CI1.72 – 7.89p<0.001Regression, Logistic

weight loss \>=5% at Week 26

Odds Ratio, log3.9595% CI2.00 – 7.78p<0.001Regression, Logistic

weight loss \>=5% at Week 26

Odds Ratio, log7.2895% CI3.72 – 14.24p<0.001Regression, Logistic

weight loss \>=5% at Week 26

Odds Ratio, log3.7195% CI1.84 – 7.45p<0.001Regression, Logistic

weight loss \>=5% at Week 54

Odds Ratio, log2.7395% CI1.46 – 5.09p0.002Regression, Logistic

weight loss \>=5% at Week 54

Odds Ratio, log4.4895% CI2.42 – 8.30p<0.001ANCOVA

weight loss \>=5% at Week 54

Odds Ratio, log8.4795% CI1.02 – 70.17p0.048Regression, Logistic

weight loss \>=10% at Week 26

Odds Ratio, log13.8195% CI1.85 – 102.91p0.010Regression, Logistic

weight loss \>=10% at Week 26

Odds Ratio, log13.0995% CI1.75 – 97.68p0.012Regression, Logistic

weight loss \>=10% at Week 26

Odds Ratio, log6.9295% CI1.49 – 32.07p0.013Regression, Logistic

weight loss \>=10% at Week 54

Odds Ratio, log4.9895% CI1.15 – 21.60p0.032Regression, Logistic

weight loss \>=10% at Week 54

Odds Ratio, log7.9195% CI1.86 – 33.64p0.005Regression, Logistic

weight loss \>=10% at Week 54

Secondary/protocol endpoint

Percent Change in Body Weight

Time frame:from baseline to 26 weeks and 54 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight

Time frame:from baseline to 14 weeks, 26 weeks and 54 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight Versus Active Comparator

Time frame:from baseline to 14 weeks, 26 weeks and 54 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight Versus Active Comparator

Time frame:from baseline to 14 weeks, 26 weeks and 54 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%

Time frame:after 14 weeks, 26 weeks and 54 weeks

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Change in HbA1c

Time frame:From baseline to 14 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Placebo	-0.18	-0.34 – -0.02
MEDI0382 100 mcg	-1.01	-1.18 – -0.84
MEDI0382 200 mcg	-1.22	-1.33 – -1.11
MEDI0382 300 mcg	-1.09	-1.20 – -0.98

LS Mean Difference-0.8395% CI-1.06 – -0.59p<0.001ANCOVA

LS Mean Difference-1.0495% CI-1.23 – -0.85p<0.001ANCOVA

LS Mean Difference-0.9195% CI-1.11 – -0.72p<0.001ANCOVA

Primary/protocol endpoint

Change in HbA1c

Time frame:From baseline to 14 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in HbA1c

Time frame:from baseline to 26 weeks and 54 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Placebofrom baseline to 26 weeks	-0.40	-0.58 – -0.22
from baseline to 54 weeks	-0.44	-0.63 – -0.24
MEDI0382 100 mcgfrom baseline to 26 weeks	-1.06	-1.25 – -0.87
from baseline to 54 weeks	-0.96	-1.16 – -0.75
MEDI0382 200 mcgfrom baseline to 26 weeks	-1.22	-1.34 – -1.10
from baseline to 54 weeks	-1.06	-1.19 – -0.93
MEDI0382 300 mcgfrom baseline to 26 weeks	-1.12	-1.24 – -1.00
from baseline to 54 weeks	-1.01	-1.14 – -0.88

LS Mean Difference-0.6695% CI-0.92 – -0.40p<0.001ANCOVA

Week 26

LS Mean Difference-0.8195% CI-1.03 – -0.60p<0.001ANCOVA

Week 26

LS Mean Difference-0.7295% CI-0.94 – -0.51p<0.001ANCOVA

Week 26

LS Mean Difference-0.5295% CI-0.80 – -0.24p<0.001ANCOVA

Week 54

LS Mean Difference-0.6395% CI-0.86 – -0.39p<0.001ANCOVA

Week 54

LS Mean Difference-0.5795% CI-0.80 – -0.34p<0.001ANCOVA

Week 54

Secondary/registry result

Percentage of Participants Achieving an HbA1c Target < 7.0%

Time frame:after 14, 26, and 54 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placeboafter 14 weeks	19	—
after 26 weeks	25	—
after 54 weeks	23	—
MEDI0382 100 mcgafter 14 weeks	50	—
after 26 weeks	48	—
after 54 weeks	52	—
MEDI0382 200 mcgafter 14 weeks	143	—
after 26 weeks	139	—
after 54 weeks	125	—
MEDI0382 300 mcgafter 14 weeks	143	—
after 26 weeks	143	—
after 54 weeks	128	—

Odds Ratio, log6.6792% CI3.34 – 13.30p<0.001Regression, Logistic

Week 14

Odds Ratio, log9.9595% CI5.39 – 18.36p<0.001Regression, Logistic

Week 14

Odds Ratio, log8.5295% CI4.65 – 15.61p<0.001Regression, Logistic

Week 14

Odds Ratio, log3.7495% CI1.98 – 7.03p<0.001Regression, Logistic

Week 26

Odds Ratio, log5.4095% CI3.13 – 9.34p<0.001Regression, Logistic

Week 26

Odds Ratio, log5.2095% CI3.02 – 8.97p<0.001Regression, Logistic

Week 26

Odds Ratio, log4.9495% CI2.61 – 9.36p<0.001Regression, Logistic

Week 54

Odds Ratio, log4.5595% CI2.62 – 7.89p<0.001Regression, Logistic

Week 54

Odds Ratio, log4.3495% CI2.51 – 7.51p<0.001Regression, Logistic

Week 54

Secondary/registry result

Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control

Time frame:at 14 weeks, 26 weeks and 54 weeks

threshold achievement, event

componentsrescue therapy for glycemic control, discontinuation for lack of glycemic control

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placeboreceived rescue medication at 14 wks	11	—
received rescue medication at 26 wks	20	—
received rescue medication at 54 wks	34	—
discontinued study IP at 14 wks	2	—
discontinued study IP at 26 wks	4	—
discontinued study IP at 54 wks	4	—
MEDI0382 100 mcgreceived rescue medication at 14 wks	1	—
received rescue medication at 26 wks	3	—
received rescue medication at 54 wks	10	—
discontinued study IP at 14 wks	0	—
discontinued study IP at 26 wks	1	—
discontinued study IP at 54 wks	1	—
MEDI0382 200 mcgreceived rescue medication at 14 wks	3	—
received rescue medication at 26 wks	8	—
received rescue medication at 54 wks	26	—
discontinued study IP at 14 wks	1	—
discontinued study IP at 26 wks	2	—
discontinued study IP at 54 wks	3	—
MEDI0382 300 mcgreceived rescue medication at 14 wks	2	—
received rescue medication at 26 wks	6	—
received rescue medication at 54 wks	24	—
discontinued study IP at 14 wks	0	—
discontinued study IP at 26 wks	0	—
discontinued study IP at 54 wks	0	—

Odds Ratio, log0.0995% CI0.01 – 0.73p0.024Regression, Logistic

received rescue medication at 14 wks

Odds Ratio, log0.1195% CI0.03 – 0.40p<0.001Regression, Logistic

received rescue medication at 14 wks

Odds Ratio, log0.0795% CI0.02 – 0.33p<0.001Regression, Logistic

received rescue medication at 14 wks

Odds Ratio, log0.1495% CI0.04 – 0.48p0.002Regression, Logistic

received rescue medication at 26 wks

Odds Ratio, log0.1495% CI0.06 – 0.34p<0.001Regression, Logistic

received rescue medication at 26 wks

Odds Ratio, log0.1195% CI0.04 – 0.28p<0.001Regression, Logistic

received rescue medication at 26 wks

Odds Ratio, log0.2495% CI0.11 – 0.53p<0.001Regression, Logistic

received rescue medication at 54 wks

Odds Ratio, log0.2495% CI0.13 – 0.44p<0.001Regression, Logistic

received rescue medication at 54 wks

Odds Ratio, log0.2295% CI0.12 – 0.41p<0.001Regression, Logistic

received rescue medication at 54 wks

Odds Ratio, log0.2295% CI0.02 – 2.43p0.216Regression, Logistic

discontinued IP at 14 wks

Odds Ratio, log0.2895% CI0.03 – 2.52p0.253Regression, Logistic

discontinued IP at 26 wks

Odds Ratio, log0.2195% CI0.04 – 1.19p0.079Regression, Logistic

discontinued IP at 26 wks

Odds Ratio, log0.2795% CI0.03 – 2.50p0.252Regression, Logistic

discontinued IP at 54 wks

Odds Ratio, log0.3295% CI0.07 – 1.47p0.143Regression, Logistic

discontinued IP at 54 wks

Secondary/protocol endpoint

Change in HbA1c

Time frame:from baseline to 26 weeks and 54 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving an HbA1c Target < 7.0%

Time frame:after 14, 26, and 54 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control

Time frame:at 14 weeks, 26 weeks and 54 weeks

threshold achievement, event

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)

Time frame:Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	95% CI
MEDI0382 100 mcgWeek 1	2.68	—
Week 2	2.66	—
Week 6	2.75	—
Week 10	3.18	—
Week 14	3.79	—
Week 18	4.58	—
Week 22	4.63	—
Week 26	4.39	—
Week 54	4.58	—
MEDI0382 200 mcgWeek 1	2.76	—
Week 2	5.13	—
Week 6	5.20	—
Week 10	5.74	—
Week 14	6.50	—
Week 18	7.43	—
Week 22	8.07	—
Week 26	8.12	—
Week 54	8.99	—
MEDI0382 300 mcgWeek 1	2.77	—
Week 2	5.18	—
Week 6	7.77	—
Week 10	8.23	—
Week 14	9.71	—
Week 18	10.8	—
Week 22	11.5	—
Week 26	12.9	—
Week 54	13.2	—

Secondary/registry result

Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)

Time frame:Baseline through 54-week treatment period and 28-day follow-up

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
PlaceboADA positive at baseline	1	—
ADA incidence	3	—
ADA positive post-baseline	3	—
MEDI0382 100 mcgADA positive at baseline	1	—
ADA incidence	55	—
ADA positive post-baseline	54	—
MEDI0382 200 mcgADA positive at baseline	0	—
ADA incidence	152	—
ADA positive post-baseline	152	—
MEDI0382 300 mcgADA positive at baseline	0	—
ADA incidence	155	—
ADA positive post-baseline	155	—

Secondary/registry result

Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants

Time frame:Baseline through 54-week treatment period and 28-day follow-up

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (median), titer	95% CI
PlaceboADA positive at baseline, median titer	5.0	5 – 5
ADA incidence, median of maximum titer	5.0	5 – 20
ADA positive post-baseline, median of max. titer	5.0	5 – 20
MEDI0382 100 mcgADA positive at baseline, median titer	5.0	5 – 5
ADA incidence, median of maximum titer	20.0	5 – 2560
ADA positive post-baseline, median of max. titer	20.0	5 – 2560
MEDI0382 200 mcgADA positive at baseline, median titer	0	0 – 0
ADA incidence, median of maximum titer	20.0	5 – 640
ADA positive post-baseline, median of max. titer	20.0	5 – 640
MEDI0382 300 mcgADA positive at baseline, median titer	0	0 – 0
ADA incidence, median of maximum titer	20.0	5 – 5120
ADA positive post-baseline, median of max. titer	20.0	5 – 5120

Secondary/protocol endpoint

Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)

Time frame:Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)

Time frame:Baseline through 54-week treatment period and 28-day follow-up

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants

Time frame:Baseline through 54-week treatment period and 28-day follow-up

Immunogenicity (ADA)

descriptive

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

Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study.
Diabetes care2021 Jun (month)PMID34016612doi:10.2337/dc20-2151via clinicaltrials gov reference derived + pubmed nct search

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.