GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 1

Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment

A Phase I, Parallel-group, Multi-center, Open-label, Investigation of the Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Injection of Cotadutide in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function

Lead sponsor

AstraZeneca

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI 18-40

Primary endpoints

•Maximum observed plasma (peak) drug concentration [Cmax]•Area under plasma concentration time curve from zero to infinity (AUCinf)•Area under the plasma concentration-curve

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 IDNCT05517226

Org study IDD5671C00008

Timeline

Milestones

Study first posted2022-08-26actual

Study start2022-09-06actual

Primary completion2023-02-27actual

Study completion2023-02-27actual

Last update posted2023-03-21actual

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participant must be ≥ 18 to ≤ 85 years of age at the time of signing the Informed Consent Form (ICF).

•Body mass index ≥ 18 kg/m2 to < 40 kg/m2.

•Female participants of childbearing potential must use at least one highly effective form of birth control.

•Capable of giving signed informed consent.

Participants with hepatic impairment only

- Diagnosis of chronic (≥ 6 months) and stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study Screening).

Exclusion criteria

All participants

•History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to cotadutide.

•Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QT interval corrected for heart rate using Fridericia's formula (QTcF), including abnormal ST-T-wave morphology, or left ventricular hypertrophy

1. Prolonged QTcF > 470 ms or family history of long QT syndrome.

2. PR (PQ) interval shortening < 120 ms.

3. PR (PQ) interval prolongation (> 220 ms) intermittent or permanent second or third degree atrioventricular (AV) block, or AV dissociation.

4. Persistent or intermittent complete bundle branch block, or intraventricular conduction delay with QRS > 119 ms.

•Any evidence of additional severe or uncontrolled systemic disease or laboratory finding that makes it unsafe for the participant to participate in the study.

•Impaired renal function, defined as estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2 at Screening.

•Any positive result on Screening for serum hepatitis B surface antigen, anti-Core HBV antibody, hepatitis C antibody, or human immunodeficiency virus (HIV).

•Any sign and confirmation of coronavirus disease 2019 (COVID19) infection:

•Participants with concurrent or previous use of a glucagon-like peptide-1 (GLP1) receptor agonist.

•Use of prohibited prescribed or nonprescribed medication during the 2 weeks prior to the first administration of Investigational Medicinal Product (IMP) or longer if the medication has a long half-life.

•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.

•Presence of hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.

Participants with hepatic impairment only

•Severe portal hypertension or surgical porto-systemic shunts.

•Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.

•Clinically relevant hepatic encephalopathy.

•Severe ascites defined as ascites requiring paracentesis and albumin at 4-week intervals or less.

•Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the 28-day Screening period.

•Post liver transplantation.

•Platelet count < 50 × 109/L and/or neutrophil count < 1.2 × 109/L and/or hemoglobin < 8.5 g/dL or INR >2.3.

Participants with normal hepatic function only

•History or presence of hepatic disease or evidence of other known forms of known chronic liver disease.

•History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

•Urinary albumin-to-creatinine ratio > 3 mg/μmol.

Endpoints (9)

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

9 endpoints

Primary/protocol endpoint

Maximum observed plasma (peak) drug concentration [Cmax]

Time frame:Day 1 to Day 3

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under plasma concentration time curve from zero to infinity (AUCinf)

Time frame:Day 1 to Day 3

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)

Time frame:Day 1 to Day 3

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Time to reach peak or maximum observed concentration or response following drug administration (tmax)

Time frame:Day 1 to Day 3

Tmax

descriptive

Primary/protocol endpoint

Terminal half-life (t½λz)

Time frame:Day 1 to Day 3

Half-life

descriptive

Primary/protocol endpoint

Apparent total body clearance (CL/F)

Time frame:Day 1 to Day 3

descriptive

Primary/protocol endpoint

Apparent volume of distribution based on the terminal phase (Vz/F)

Time frame:Day 1 to Day 3

descriptive

Secondary/protocol endpoint

Number of participants with Adverse Events (AEs)

Time frame:From time of first dose to the final follow-up visit (Day 29)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Incidence of ADAs (anti-drug antibodies)

Time frame:From time of first dose to the final follow-up visit (Day 29)

Immunogenicity (ADA)

descriptive

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.