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

NCT05804162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-11-01

No results posted yet for this study

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

Interventions

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.

DRUG

Cagrilintide Placebo

Participants will receive cagrilintide placebo subcutaneously once weekly.

DRUG

Moxifloxacin

Partcipants will receive a single dose of moxifloxacin orally.

DRUG

Moxifloxacin Placebo

Partcipants will receive a single dose of moxifloxacin orally.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency Dept. 2834 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2023-08-12
Completion
2023-09-18

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05804162 on ClinicalTrials.gov