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

NCT05804162 | Completed Phase 1

• 3 other identifiers: NN9838-4672U1111-1249-38342022-002357-25
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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

  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

  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

  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

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

Study Arms (3)

Cagrilintide (Arm 1)

EXPERIMENTAL

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; Drug: Moxifloxacin Placebo

Cagrilintide Placebo (Arm 2A)

ACTIVE COMPARATOR

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: Cagrilintide Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Cagrilintide Placebo (Arm 2B)

ACTIVE COMPARATOR

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: Cagrilintide Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Interventions

Cagrilintide DRUG

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.

Also known as: Cagrilintide A, NNC0174-0833 A

Cagrilintide (Arm 1)

Cagrilintide Placebo DRUG

Participants will receive cagrilintide placebo subcutaneously once weekly.

Also known as: Cagrilintide A, NNC0174-0833 A

Cagrilintide Placebo (Arm 2A); Cagrilintide Placebo (Arm 2B)

Moxifloxacin DRUG

Partcipants will receive a single dose of moxifloxacin orally.

Also known as: Moxifloxacinratiopharm

Cagrilintide Placebo (Arm 2A); Cagrilintide Placebo (Arm 2B)

Moxifloxacin Placebo DRUG

Partcipants will receive a single dose of moxifloxacin orally.

Cagrilintide (Arm 1); Cagrilintide Placebo (Arm 2A); Cagrilintide Placebo (Arm 2B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

Related Publications (1)

• 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 Dec;26(12):5805-5811. doi: 10.1111/dom.15951. Epub 2024 Sep 16.

  PMID: 39279639 RESULT

MeSH Terms

Conditions

Obesity

Interventions

cagrilintide; Moxifloxacin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Transparency Dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: April 12, 2023
• Primary Completion: August 12, 2023
• Study Completion: September 18, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)