Efficacy and Safety of Cagrilintide Monotherapy and Cagrilintide plus Semaglutide for Weight Management in Children and Adolescents with Overweight or Obesity

The primary objective of this study is to evaluate the efficacy of cagrilintide 2.4 mg administered subcutaneously once weekly as monotherapy, and the combination of cagrilintide and semaglutide (CagriSema) 2.4 mg/2.4 mg administered subcutaneously once weekly, for weight management in children and adolescents with overweight or obesity. The study aims to confirm the superiority of these interventions compared to a placebo.

Secondary objectives include:

• Confirmation of the superiority of CagriSema 2.4 mg/2.4 mg subcutaneously once weekly compared to semaglutide 2.4 mg subcutaneously once weekly regarding weight management.
• Assessment of the safety and pharmacokinetics of the investigated treatments.

This clinical trial involves a total of 303 participants diagnosed with obesity and type 2 diabetes. The study population consists of male and female pediatric patients aged 8 to <18 years. Selection is based on a body mass index corresponding to the ≥95th percentile for children aged 8 to <12 years, or the ≥95th percentile, or the ≥85th percentile with an obesity-related complication, for adolescents aged 12 to <18 years. Eligible individuals must have a body weight greater than 45 kg and a history of at least one unsuccessful attempt to lose weight through a structured lifestyle modification program involving diet and exercise counseling for a minimum of 3 months. Participants may be receiving a lifestyle intervention or stable treatment with metformin. Inclusion requires HbA1c levels ≤10.0% and specific laboratory parameters for total calcium, phosphate, alkaline phosphatase, and parathyroid hormone within normal ranges.

This Phase III clinical trial is designed to evaluate the efficacy, safety, and pharmacokinetics of cagrilintide administered as a monotherapy and in combination with semaglutide (CagriSema) for weight management. The study focuses on children and adolescents presenting with obesity or overweight, including those with type 2 diabetes. Participants are expected to receive subcutaneous injections once weekly. The research methodology involves comparing the test products against a placebo to confirm superiority in weight management outcomes. The primary endpoint is the relative change in body mass index from baseline to the end of the 68-week treatment period. The study sequence includes a screening visit to assess eligibility through body mass index percentile calculations, laboratory parameters, and HbA1c levels, followed by the treatment phase and an end-of-study assessment. Total participant involvement in the treatment phase is expected to last 68 weeks.

Cagrilintide semaglutide is an experimental medication administered as a solution for injection via the subcutaneous route. The dosage is 2.4 mg of cagrilintide and 2.4 mg of semaglutide, provided on a once weekly schedule.

Cagrilintide is an experimental medication administered as a solution for injection via the subcutaneous route. The dosage is 2.4 mg, provided on a once weekly schedule.

Semaglutide is a comparator treatment administered as a solution for injection via the subcutaneous route. The dosage is 2.4 mg, provided on a once weekly schedule.

Placebo is utilized in the study as a non-experimental treatment.

The primary efficacy endpoint is the relative change in body mass index (BMI) from baseline at week 0 to the end of treatment at week 68, expressed as a percentage. Secondary efficacy parameters include:

• Relative change in body weight from baseline to week 68, expressed as a percentage.
• Change in BMI Standard Deviation Score (SDS) from baseline to week 68.
• Reduction in weight category from baseline to week 68, measured by the count of participants.