Trial · Interventional
RecruitingPhase 3Registry dataA Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 460 participants (estimated)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
26 countries
United States, Australia, Austria, Belgium, Bulgaria, China, Colombia, Croatia, Denmark, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Taiwan, Thailand, United Kingdom
- Start
- 8 Jan 2026
- Primary completion
- 20 Mar 2030 (estimated)
- Completion
- 20 Sept 2033 (estimated)
- First posted
- 28 Nov 2025
- Last update posted
- 30 Sept 2026
- Conditions
- Overweight · Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
NCT072532858 Jan 2026 to est. 20 Sept 2033
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CagrilintideDrug
- SemaglutideDrug
- Placebo cagrilintideDrug
- Placebo semaglutideDrug
Arms4
Experimental
CagriSema
Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks.
Experimental
Semaglutide
Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks.
Experimental
Cagrilintide
Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks.
Placebo comparator
Placebo
Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Relative change in body mass index (BMI)
Time frame · Baseline (week 0), week 68
Registry description
Measured in percentage (%).
Secondary outcomes(20)
Relative change in body weight
Time frame · Baseline (week 0), week 68
Registry description
Measured in %.
Change in BMI Standard Deviation Score (SDS)
Time frame · Baseline (week 0), week 68
Registry description
Measured as SDS score.
Relative change in BMI
Time frame · Baseline (week 0), week 68 and week 224
Registry description
Measured in %.
Number of participants in weight category reduction
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=10% reduction of body weight (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=15% reduction of body weight (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=20% reduction of body weight (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=25% reduction of body weight (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=5% reduction of BMI (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=10% reduction of BMI (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=15% reduction of BMI (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=20% reduction of BMI (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved >=25% reduction of BMI (yes/no)
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who achieved normal BMI
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Number of participants who shifted from obese to non-obese BMI class
Time frame · Baseline (week 0), week 68
Registry description
Measured as count of participants.
Change in waist circumference
Time frame · Baseline (week 0), week 68 and week 224
Registry description
Measured in centimeter (cm).
Change in waist-to-height ratio
Time frame · Baseline (week 0), week 68
Registry description
Measured as ratio.
Absolute change in total fat mass by dual energy X-ray absorption (DXA)
Time frame · Baseline (week 0), week 68
Registry description
Measured in kilograms (kg).
Relative to baseline change in total fat mass by DXA
Time frame · Baseline (week 0), week 68
Registry description
Measured in %.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 8 Years up to 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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