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

Sponsor
Novo Nordisk A/S
Study ID
NCT05804162
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

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.
  • Cagrilintide Placebo — DRUG
    Participants will receive cagrilintide placebo subcutaneously once weekly.
  • Moxifloxacin — DRUG
    Partcipants will receive a single dose of moxifloxacin orally.
  • Moxifloxacin Placebo — DRUG
    Partcipants will receive a single dose of moxifloxacin orally.

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
Oct 2024
Primary completion
Aug 12, 2023
Completion
Sep 18, 2023

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 ]

Related Studies