GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 1

A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants

A Thorough QTc Evaluation of the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel Study With a Nested Crossover Design for Positive Control With Moxifloxacin Administration

Lead sponsor

AstraZeneca

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-29.9•Healthy volunteers

Primary endpoint

•Time-matched change-from-baseline Fridericia's correction of QT interval (QTcF)

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 IDNCT05668936

Org study IDD5671C00010

Secondary ID2022-002479-12

Timeline

Milestones

Study first posted2022-12-30actual

Study start2023-01-03actual

Primary completion2023-03-10actual

Study completion2023-03-10actual

Last update posted2023-04-05actual

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy male and female participants of age 18 to 55 years.

•Females must have a negative pregnancy test.

•Have a Body Mass Index (BMI) of ≥ 18 and ≤ 29.9 kg/m^2.

Exclusion criteria

•History or presence of any clinically significant disease or disorder.

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

•History of acute or chronic pancreatitis.

•Family history of sudden cardiac death before the age of 50 of a first-degree relative.

•History of additional risk factors for Torsade de Pointes (eg, heart failure, clinically important bradycardia and electrolyte disturbances eg, hypokalemia, hypocalcemia, hypomagnesemia or family history of long QT syndrome).

•History of neoplastic disease

•Any clinically significant abnormalities in clinical chemistry, hematology, urinalysis results or vital signs.

•Any clinically significant abnormalities in rhythm, conduction, or morphology of the 12-lead resting electrocardiogram (ECG).

•Any positive result on screening for serum hepatitis B surface antigen OR anti-HBc antibody, indicative of active hepatitis B (ie, participants with positive anti-HBc antibody result are acceptable if anti HBc IgM antibodies are negative), hepatitis C antibody, and Human immunodeficiency virus (HIV) antibody.

•Current smokers or those who have smoked or used nicotine products (including e-cigarettes).

•Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.

•Use of drugs with enzyme-inducing properties such as St John's Wort.

•Participant has a positive test result for SARS-CoV-2 RT-PCR during screening period or at baseline.

•Participant has clinical signs and symptoms consistent with COVID-19 or a history of severe COVID-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).

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

Safety / tolerability / PK

Cardiometabolic biomarkers

11 endpoints

Secondary/protocol endpoint

Change from baseline in Heart rate (HR)

Time frame:From Day 2 up to Day 92 or early discontinuation

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Number of participants with significant change in HR

Time frame:From Day 2 up to Day 92 or early discontinuation

Heart rate, change

threshold achievement, descriptive

Secondary/protocol endpoint

Change from baseline in mean systolic blood pressure (SBP)

Time frame:Up to Day 92

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from baseline in mean diastolic blood pressure (DBP)

Time frame:Up to Day 92

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from baseline in mean HR

Time frame:Up to Day 92

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Placebo-corrected mean change from baseline in SBP

Time frame:Up to Day 92

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Placebo-corrected mean change from baseline in DBP

Time frame:Up to Day 92

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Placebo-corrected mean change from baseline in HR

Time frame:Up to Day 92

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Number of participants with significant change in SBP

Time frame:Up to Day 92

Systolic BP, change

threshold achievement, improvement

LOINC 8480-6

Secondary/protocol endpoint

Number of participants with change in DBP

Time frame:Up to Day 92

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Number of participants with significant change in HR

Time frame:Up to Day 92

Heart rate, change

threshold achievement, improvement

Safety / tolerability / PK

15 endpoints

Primary/protocol endpoint

Time-matched change-from-baseline Fridericia's correction of QT interval (QTcF)

Time frame:Up to Day 92

change from baseline, event

Secondary/protocol endpoint

Change from baseline in QTcF

Time frame:Up to Day 94

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in PR interval

Time frame:From Day 2 up to Day 92 or early discontinuation

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in QRS interval

Time frame:From Day 2 up to Day 92 or early discontinuation

change from baseline, descriptive

Secondary/protocol endpoint

Number of participants with significant change in QTcF

Time frame:From Day 2 up to Day 92 or early discontinuation

threshold achievement, event

Secondary/protocol endpoint

Number of participants with significant change in PR interval

Time frame:From Day 2 up to Day 92 or early discontinuation

threshold achievement, event

Secondary/protocol endpoint

Number of participants with significant change in QRS interval

Time frame:From Day 2 up to Day 92 or early discontinuation

threshold achievement, event

Secondary/protocol endpoint

Number of treatment-emergent changes in T-wave morphology

Time frame:From Day 2 up to Day 92 or early discontinuation

event count, event

Secondary/protocol endpoint

Number of treatment-emergent changes in U-waves presence

Time frame:From Day 2 up to Day 92 or early discontinuation

event count, event

Secondary/protocol endpoint

Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) of cotadutide

Time frame:Day 57 and Day 91

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under concentration-time curve in the dose interval (AUCtau) of cotadutide

Time frame:Day 57 and Day 91

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed plasma concentration (Cmax) of cotadutide

Time frame:Day 57 and Day 91

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to reach maximum observed plasma concentration (tmax) of cotadutide

Time frame:Day 57 and Day 91

Tmax

descriptive

Secondary/protocol endpoint

Number of participants with Adverse Events (AEs)

Time frame:Up to follow-up visit 28 days post last dose (approximately Day 120)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of participants with Antidrug Antibodies to cotadutide

Time frame:Day 2, 30, 57, 91 and Day 120 (follow-up visit 28 days post last dose)

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.