A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8-18
SponsorNovo Nordisk A/S
About this trial
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
Male or female.
Disqualifiers
Treatment with any medication prescribed for obesity or weight management within 90 days before screening.
Liposuction and/or abdominoplasty, if performed > 1 year before screening.
Adjustable gastric banding, if the band has been removed > 1 year before screening.
Intragastric balloon, if the balloon has been removed > 1 year before screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Cagrilintide
DrugParticipants will receive cagrilintide subcutaneously.
Semaglutide
DrugParticipants will receive semaglutide subcutaneously.
Placebo cagrilintide
DrugParticipants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide
DrugParticipants will receive placebo matched to semaglutide subcutaneously.
Treatment groups
460 Participants
are divided into 4 treatment groupsGroup A: CagriSemaExperimental treatment 4 interventions
Group B: SemaglutideExperimental treatment 2 interventions
Group C: CagrilintideExperimental treatment 2 interventions
Group D: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Relative change in body mass index (BMI)
Measured in percentage (%).
Time frame
Baseline (week 0), week 68Secondary outcomes
1
Relative change in body weight
Measured in %.
Time frame
Baseline (week 0), week 682
Change in BMI Standard Deviation Score (SDS)
Measured as SDS score.
Time frame
Baseline (week 0), week 683
Relative change in BMI
Measured in %.
Time frame
Baseline (week 0), week 68 and week 2244
Number of participants in weight category reduction
Measured as count of participants.
Time frame
Baseline (week 0), week 68Sponsors and contacts
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Source ClinicalTrials.gov