DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05804162

CompletedPhase 1

A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants

A Thorough QTc Study Evaluating the Effect of Cagrilintide on Cardiac Repolarisation in Healthy Participants

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

1

Recruiting sites

—

Enrollment

107

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 23-29.9

Primary endpoint

•Fridericia Heart Rate Corrected QT Interval (QTcF) At 12, 24, 48

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 IDNCT05804162
Org study IDNN9838-4672
Secondary ID2022-002357-25
Secondary IDU1111-1249-3834World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-04-07actual
Study start2023-04-12actual
Primary completion2023-08-12actual
Study completion2023-09-18actual
Last update posted2024-11-01actual

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female.
•Aged 18-55 years (both inclusive) at the time of signing informed consent.
•Body mass index (BMI) between 23.0 and 29.9 kilogram per meter^2 (kg/m^2) (both inclusive) at screening.

Exclusion criteria

•Known or suspected hypersensitivity to trial products or related products, or to electrocardiogram (ECG) electrodes.
•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
•History of seizures, epilepsy, repeated syncopes, cardiac arrest, cardiac arrhythmia or Torsades de Pointes (TdP), 2nd or 3rd degree atrioventricular (A-V) block or structural heart disease.
•Family history of long QT syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative).

Endpoints (6)

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

6 endpoints
Primary/protocol endpoint

Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) At 12, 24, 48 and 72 Hours Post-Second Dose of Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Level

Time frame:From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo

Time frame:Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55

change from baseline, descriptive

Secondary/protocol endpoint

Change from Baseline in QT Interval Corrected Individually for HR (QTcI) at 12, 24, 48 and 72 Hours Post-Second Dose of Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Level

Time frame:From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55

change from baseline, event

Secondary/protocol endpoint

Occurrence of Absolute QTcF Interval Prolongation: QTcF Interval > 450 millisecond (ms), QTcF Interval > 480 ms and QTcF Interval > 500 msB on ECG Recordings 0-72 Hours after Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Levels

Time frame:From pre-last dose on Day 52 to 72 hours post-last dose on Day 55

threshold achievement, event

Secondary/protocol endpoint

Occurrence of QTcF Interval Increases from Baseline > 30 ms and QTcF Interval Increases from Baseline > 60 ms Based on ECG Recordings 0-72 Hours after Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Levels

Time frame:From pre-last dose on Day 52 to 72 hours post-last dose on Day 55

threshold achievement, event

Secondary/protocol endpoint

Change from Baseline in QT Interval Corrected Individually for HR (QTcI) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo

Time frame:Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55

change from baseline, 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.