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

The study tests if treatment with cagrilintide delays the transmission of electrical signals in the heart compared to treatment with placebo. To confirm the sensitivity of the methodology, the drug moxifloxacin is also compared to a placebo in 2 treatment arms. Cagrilintide is being developed for the treatment of obesity and weight management. Moxifloxacin is an approved antibiotic for the treatment of bacterial illnesses. The study lasts for up to 17 weeks for each participant.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Cagrilintide; Drug: Moxifloxacin Placebo; Drug: Cagrilintide Placebo; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cagrilintide (Arm 1); Participants will receive 0.6 milligrams (mg) of cagrilintide subcutaneously once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose moxifloxacin placebo at the end of the treatment period will be administered orally.	Drug: Cagrilintide; Participants will receive 0.6 mg subcutaneous injections of cagrilintide once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period.; Other Names: Cagrilintide A; NNC0174-0833 A; Drug: Moxifloxacin Placebo; Partcipants will receive a single dose of moxifloxacin orally.
Active Comparator: Cagrilintide Placebo (Arm 2A); Participants will receive cagrilintide placebo subcutaenously once weekly. In addition, a single dose of moxifloxacin active prior to initiation of treatment and a single dose of moxifloxacin placebo at the end of the treatment period will be administered orally.	Drug: Moxifloxacin Placebo; Partcipants will receive a single dose of moxifloxacin orally.; Drug: Cagrilintide Placebo; Participants will receive cagrilintide placebo subcutaneously once weekly.; Other Names: Cagrilintide A; NNC0174-0833 A; Drug: Moxifloxacin; Partcipants will receive a single dose of moxifloxacin orally.; Other Names: Moxifloxacinratiopharm
Active Comparator: Cagrilintide Placebo (Arm 2B); Participants will receive cagrilintide placebo subcutaneously once weekly. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose of moxifloxacin active at the end of the treatment period will be administered orally.	Drug: Moxifloxacin Placebo; Partcipants will receive a single dose of moxifloxacin orally.; Drug: Cagrilintide Placebo; Participants will receive cagrilintide placebo subcutaneously once weekly.; Other Names: Cagrilintide A; NNC0174-0833 A; Drug: Moxifloxacin; Partcipants will receive a single dose of moxifloxacin orally.; Other Names: Moxifloxacinratiopharm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured in millisecond	From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo	Measured in millisecond	Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55
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	Measured in millisecond	From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55
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	Measured as count of participants	From pre-last dose on Day 52 to 72 hours post-last dose on Day 55
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	Measured as count of participants	From pre-last dose on Day 52 to 72 hours post-last dose on Day 55
Change from Baseline in QT Interval Corrected Individually for HR (QTcI) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo	Measured in millisecond	Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Publications and helpful links

General Publications

• Gabe MBN, Fuhr R, Sinn A, Eliasen A, Berthelsen KK, Kuhlman AB, Baekdal TA, Nejad AB. Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. Diabetes Obes Metab. 2024 Sep 16. doi: 10.1111/dom.15951. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): August 12, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Contraceptive Agents, Hormonal; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Reproductive Control Agents; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: NN9838-4672; U1111-1249-3834 (Other Identifier: World Health Organization (WHO)); 2022-002357-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No