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A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
A Randomized, Blinded, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Ascending Doses of MEDI0382 in Non-diabetic Obese Subjects
Lead sponsor
Asset
Cotadutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
2
Recruiting sites
—
Enrollment
51
actual
Study population
Obesity / overweight
Key I/E criteria
•BMI ≥35•HbA1c ≤6.5%
Primary endpoints
•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Treatment-emergent AEs (any)•Blood Pressure
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
Key Inclusion Criteria:
1. Provision of written informed consent
2. Male and female participants age 18 through 65 years
3. BMI ≥ 35 kg/m^2
4. Hemoglobin A1c level of < 6.5%
5. Female participants must have a negative pregnancy test and must not be lactating.
6. Females of childbearing potential using appropriate birth control to avoid pregnancy during the study.
7. Stable body weight
8. Willing and able to adhere to the visit/protocol schedule, including following lifestyle advice with respect to diet and exercise for the duration of the study
9. Willing and able to self-administer daily SC injections following an initial self-injection training
Key Exclusion Criteria:
1. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to Study Day 1 dosing.
2. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of participants safety or study results.
3. Active participation in any other investigation clinical study.
4. Any prescription or non-prescription drugs for weight loss including herbal or other dietary supplements used within the past 3 months prior to screening.
5. Previous glucagon-like peptide-1 (GLP-1) use within 3 months prior to screening.
6. Any positive results for serum hepatitis B surface antigen, hepatitis C virus antibody and/or human immunodeficiency virus (HIV) antibody at screening.
7. Laboratory tests results as specified in the protocol (laboratory tests may be repeated once for confirmation of out of range values at screening).
8. Significant hepatic or renal impairment
9. Poorly controlled hypertension
10. Known or suspected history of drug or alcohol abuse within the past year or positive current test
11. Previous surgical procedures for weight loss
Endpoints (17)
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
Cardiometabolic biomarkers
2 endpointsChange in Blood Pressure from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame:From Baseline (Day -1) through end of dosing (Day 63)
change from baseline, improvement
Change in Pulse Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame:From Baseline (Day -1) through end of dosing (Day 63)
Heart rate, change
change from baseline, improvement
Safety / tolerability / PK
15 endpointsNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3
Time frame:From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs for Cohorts 1, 2, and 3
Time frame:From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Treatment-emergent AEs (any)
event count, event
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs for Cohorts 1, 2, and 3
Time frame:From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Treatment-emergent AEs (any)
event count, event
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs for Cohorts 1, 2, and 3
Time frame:From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Treatment-emergent AEs (any)
event count, event
Change in Respiratory Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame:From Baseline (Day -1) through end of dosing (Day 63)
change from baseline, descriptive
Change in Temperature from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame:From Baseline (Day -1) through end of dosing ( Day 63)
change from baseline, descriptive
Maximum Observed Plasma Concentration (Cmax) of MEDI0382 for Cohort 1
Time frame:Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
Cmax
concentration, descriptive
Cmax of MEDI0382 Dose 1 on Day 1 for Cohort 1
Time frame:Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Cmax
concentration, descriptive
Area Under the Concentration-time Curve at the end of the Dosing interval (AUCτ) of MEDI0382 for Cohort 1
Time frame:Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
AUC₀–∞
concentration, descriptive
AUCτ of MEDI0382 Dose 1 on Day 1 for Cohort 1
Time frame:Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
AUC₀–∞
concentration, descriptive
Time to Maximum Observed Plasma Concentration (Tmax) of MEDI0382 for Cohort 1
Time frame:Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
Tmax
descriptive
Tmax of MEDI0382 Dose 1 on Day 1 for Cohort 1
Time frame:Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Tmax
descriptive
Plasma Concentration of MEDI0382 for Cohorts 2 and 3
Time frame:Cohort 2: predose and 6 hours postdose on Days 1, 15, 29, 43, and 57 for MEDI0382 Doses 1, 2, 3, 5, and 7, respectively; Cohort 3: predose and 6 hours postdose on Days 1, 29, 57, and 85 for MEDI0382 Doses 1, 8, 4, and 7, respectively
Plasma concentration (steady state)
concentration, descriptive
Plasma Concentration of MEDI0382 Dose 7 on Day 71 for Cohort 2 and MEDI0382 Dose 7 on Day 113 for Cohort 3
Time frame:Cohort 2: predose and 6 hours postdose on Day 71 for MEDI0382 Dose 7; Cohort 3: predose and 6 hours postdose on Day 113 for MEDI0382 Dose 7
Plasma concentration (steady state)
concentration, descriptive
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI0382 in all Cohorts
Time frame:Predose on Baseline (Day -1) and follow-up visit (28 days after the last dose) for each cohort; predose on Days 28 and 50 for Cohort 1, on Days 7, 28, 71, 98 for Cohort 2, and on Days 7, 28, 71, 126 for Cohort 3
Immunogenicity (ADA)
threshold achievement, event
Provenance
Sources
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.