GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

Lead sponsor

MedImmune LLC

Assets

Cotadutide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 27-40•HbA1c ≤8%

Primary endpoints

•Hepatic glycogen MRS change•Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume•Hepatic Glycogen Concentration Adjusted for Liver Volume

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 IDNCT03555994

Org study IDD5670C00022

Secondary ID2017-005081-22

Timeline

Milestones

Study start2018-05-31actual

Study first posted2018-06-14actual

Primary completion2021-04-14actual

Study completion2021-04-14actual

Last update posted2024-11-12actual

Results first posted2024-11-12actual

Assets

Investigational agents

Cotadutide Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2 (inclusive) at screening

•Glycated haemoglobin (HbA1c) ≤ 8.0% at screening

•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

Exclusion criteria

•Any subject who has received another investigational product as part of a clinical study or a 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

•Any subject who has received any of the following medications prior to the start of the study:

–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

–Glucagon

–Warfarin

•Any contraindication to magnetic resonance imaging/MRS scanning including claustrophobia or dislike of confined spaces

•Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening

•Recurrent unexplained hypoglycaemic episodes (defined as glucose < 3.0 mmol/L or < 54 mg/dL on more than 2 occasions in 6 months prior to screening)

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

•Acute or chronic pancreatitis

•Significant hepatic disease (except for NASH or nonalcoholic 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

•Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73m2 at screening (glomerular filtration rate estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable (International System of Units [SI] units)

•Poorly controlled hypertension defined as:

–Systolic blood pressure (BP) > 180 mm Hg

–Diastolic BP > 105 mm Hg After 10 minutes of supine rest and confirmed by repeated measurement at screening.

•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

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

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

•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

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

•Substance dependence or history of alcohol abuse and/or excess alcohol intake (defined as > 21 units per week for a male subject, and >14 units per week for a female subject). Subjects must have a negative alcohol test result at screening and prior to randomisation.

Endpoints (20)

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

MASH / liver

Other (unclassified)

MASH / liver

6 endpoints

Primary/registry result

Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only)

Time frame:Day -1 to Day 28

hepatic glycogen MRS change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo (Part A)	5.5	-47.2 – 58.3
MEDI0382 (Part A)	-100.2	-150.2 – -50.1

Least square mean difference-105.790% CI-178.8 – -32.6p0.023ANCOVA

Primary/registry result

Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B)

Time frame:Day -1 to Day 36

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change from baseline	95% CI
MEDI0382 (Part B)	-27.02	-38.04 – -16.01
Placebo (Part B)	-1.15	-11.09 – 8.79

Least square mean difference-25.8790% CI-40.88 – -10.86p0.008ANCOVA

Primary/protocol endpoint

Time frame:Day -1 to Day 36

percent change from baseline, improvement

Secondary/registry result

Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only)

Time frame:Fom baseline (Day -1) to Day 35

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage change from baseline	95% CI
Liraglutide	-5.33	-13.97 – 3.32
MEDI0382	-27.31	-36.42 – -18.20

Least Square Mean difference-21.9990% CI-34.55 – -9.43p0.008ANCOVA

Secondary/registry result

Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)

Time frame:Day -1 to Day 36

Liver fat content, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent	95% CI
Liraglutide (Part B)	-15.40	-21.09 – -9.72
MEDI0382 (Part B)	-26.26	-51.13 – -1.39
Placebo (Part B)	8.79	-10.46 – 28.05

Least Square Mean difference-35.0690% CI-66.54 – -3.58p0.070ANCOVA

Least Square Mean difference-11.7290% CI-20.13 – -3.30p0.030ANCOVA

Secondary/protocol endpoint

Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)

Time frame:Day -1 to Day 36

Liver fat content, change

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Secondary/registry result

Development of ADA

Time frame:Baseline to (Follow-up Period) 28 days post last dose + (3-month poststudy)

Immunogenicity (ADA)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo (Part A)Baseline ADA result	0	—
Day 28 ADA result for Part A Day 35 ADA result for Part B	0	—
Follow-up ADA result	0	—
Post Study ADA result	0	—
MEDI0382 (Part A)Baseline ADA result	0	—
Day 28 ADA result for Part A Day 35 ADA result for Part B	1	—
Follow-up ADA result	0	—
Post Study ADA result	0	—
MEDI0382 (Part B)Baseline ADA result	0	—
Day 28 ADA result for Part A Day 35 ADA result for Part B	3	—
Follow-up ADA result	3	—
Post Study ADA result	1	—
LiraglutideBaseline ADA result	0	—
Day 28 ADA result for Part A Day 35 ADA result for Part B	0	—
Follow-up ADA result	0	—
Post Study ADA result	0	—
Placebo (Part B)Baseline ADA result	0	—
Day 28 ADA result for Part A Day 35 ADA result for Part B	0	—
Follow-up ADA result	0	—
Post Study ADA result	0	—

Secondary/registry result

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo (Part A)At least one event	7	—
At least one IP related event	5	—
MEDI0382 (Part A)At least one event	11	—
At least one IP related event	7	—
Liraglutide (Part B)At least one event	8	—
At least one IP related event	7	—
MEDI0382 (Part B)At least one event	7	—
At least one IP related event	7	—
Placebo (Part B)At least one event	6	—
At least one IP related event	3	—

Secondary/registry result

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.0

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

Serious AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo (Part A)	0	—
MEDI0382 (Part A)	0	—
Liraglutide (Part B)	0	—
MEDI0382 (Part B)	0	—
Placebo (Part B)	0	—

Secondary/registry result

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

threshold achievement, event

componentsHeart rate, change, Systolic BP, change, Diastolic BP, change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo (Part A)	0	—
MEDI0382 (Part A)	0	—
Liraglutide (Part B)	0	—
MEDI0382 (Part B)	0	—
Placebo (Part B)	0	—

Secondary/registry result

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

descriptive, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo (Part A)	0	—
MEDI0382 (Part A)	0	—
Liraglutide (Part B)	0	—
MEDI0382 (Part B)	0	—
Placebo (Part B)	0	—

Secondary/registry result

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo (Part A)	0	—
MEDI0382 (Part A)	0	—
Liraglutide (Part B)	0	—
MEDI0382 (Part B)	0	—
Placebo (Part B)	0	—

Secondary/protocol endpoint

Development of ADA

Time frame:Baseline to (Follow-up Period) 28 days post last dose + (3-month poststudy)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

threshold achievement, event

componentsHeart rate, change, Systolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

descriptive, event

Secondary/protocol endpoint

Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters

Time frame:Post dosing (Day 1) to final follow-up (28 Days post last dose)

descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Time frame:Day -1 to Day 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Time frame:Fom baseline (Day -1) to Day 35

percent change from baseline, improvement

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

Cotadutide promotes glycogenolysis in people with overweight or obesity diagnosed with type 2 diabetes.
Nature metabolism2023 Dec (month)PMID38066113doi:10.1038/s42255-023-00938-0via 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.