A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Secondary endpoints revised (73)
    • Study sites revised (121)
    • Eligibility criteria shortened, about 2 words
  2. Study sites: 120 to 121v6
  3. Study sites: 119 to 120v5
  4. Trial sites expanded: 116 → 119 locationsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 104 to 116
    v3
  6. Study sites: 97 to 104v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
269 trials monitored
See 14 trials at risk
Obesity
3,903 trials monitored
See 160 trials at risk
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.
Trial Details
NCT Number NCT07253285
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Overweight, Obesity
Related terms Obesity, Overweight
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov