DelfaGLP-1 Atlas

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CompletedPhase 1

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

4

Recruiting sites

—

Enrollment

37

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI ≥17

Primary endpoints

•Cmax of MEDI0382(Cmax)•AUC of MEDI0382

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 IDNCT03235375
Org study IDD5670C00008

Timeline

Milestones

Study first posted2017-08-01actual
Study start2017-10-27actual
Primary completion2018-04-24actual
Study completion2018-04-24actual
Last update posted2018-05-01actual

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Must provide written informed consent
•BMI greater than or equal to 17 and less than or equal to 40 kg/m2
•Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
•Females of childbearing potential must use a highly effective form of contraception.

Exclusion criteria

•Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
•Subjects on dialysis
•Subjects with pancreatitis
•Renal transplant subjects
•Females pregnant or lactating

Endpoints (10)

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.

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Maximum Observed Concentration of MEDI0382 (Cmax)

Time frame:0-48 hours

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the Concentration Time Curve (AUC) of MEDI0382

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed concentration (Tmax)

Time frame:0-48 hours

Tmax

concentration, descriptive

Secondary/protocol endpoint

apparent clearance (Cl/F)

Time frame:0-48 hours

descriptive

Secondary/protocol endpoint

AUCinf

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Half-life (T1/2)

Time frame:0-48 hours

Half-life

descriptive

Secondary/protocol endpoint

Anti-drug Antibody (ADA) titer

Time frame:Day -1 to day 28

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Number of subjects with Adverse Events

Time frame:Study onset till 28 days post dosing

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of subjects with Adverse Events

Time frame:Study onset till 28 days post dosing

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of subjects with Adverse Events

Time frame:Study onset till 28 days post dosing

Treatment-emergent AEs (any)

event count, event

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.