RecruitingPhase 3

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

Efficacy, Safety and Pharmacokinetics of Cagrilintide s.c. 2.4 mg as Monotherapy and in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once Weekly for Weight Management in Chidren and Adolescents With Overweight or Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well CagriSema and cagrilintide help children ages 8–17 with excess body weight lose weight. In the main study, participants get one of these drugs, semaglutide, or a placebo (a treatment with no active drug), chosen by chance. The main study lasts about 1 year and 6 months; with the extension, the total time is about 4 years and 10 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 8–17 and weigh more than 45 kilograms (about 99 pounds).
  • A parent or legal representative must give written permission before study activities. The child must also agree, as appropriate for their age and local rules.
  • Ages 8–11: BMI, a measure of weight compared with height, must be at or above the 95th percentile for age and sex.
  • Ages 12–17: must have started puberty and have BMI at or above the 95th percentile, or at or above the 85th percentile with a weight-related health problem. Examples include type 2 diabetes, high blood pressure, unhealthy blood fat levels, or breathing pauses during sleep.
  • Have normal blood test results for calcium, phosphate, alkaline phosphatase, and parathyroid hormone for your age and sex.
  • Have tried a diet and exercise counseling program for at least 3 months without losing enough weight.
  • If you have type 2 diabetes: HbA1c, a test of average blood sugar, must be 10% or lower.
  • If you have type 2 diabetes: treatment must be lifestyle changes or metformin. Any metformin dose and schedule must have stayed the same for at least 56 days before screening.

Who can't join

  • Used prescription weight-loss medicine within 90 days before screening.
  • Had or plan to have weight-loss surgery or a weight-loss device. Exceptions include liposuction or a tummy tuck done over a year ago, or a stomach band, stomach balloon, or intestinal sleeve removed over a year ago.
  • Have uncontrolled thyroid disease, or obesity caused by a hormone disorder, a problem in the brain's hypothalamus, or a syndrome.
  • Your weight changed by more than 5% within 90 days before screening.
  • Have type 1 diabetes or diabetes caused by a change in a single gene.
  • If you do not have type 2 diabetes: HbA1c is 6.5% or higher, or you used medicine for diabetes or prediabetes within 90 days before screening.
  • If you have type 2 diabetes: cannot reliably notice low blood sugar, had repeated severe low blood sugar in the past year, or test positive for IA-2 or anti-GAD antibodies (immune proteins checked in blood).
  • If you have type 2 diabetes: used diabetes medicine other than metformin within 90 days before screening, or have uncontrolled diabetes-related eye damage that may worsen.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: * 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. * Aged 8 to less than (\<) 18 years at the time of signing the informed consent. * Body mass index (BMI), at screening, corresponding to: * Greater than or equal to (\>=) 95th percentile for children aged 8 to \< 12 years (Tanner stage 1-5) * \>= 95th percentile or \>= 85th percentile with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to \< 18 years (Tanner stage 2-5). * Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone. * History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months. * Body weight greater than (\>) 45 kilograms (kg) at screening. For participants with T2D at screening the following inclusion criteria also apply * Glycated haemoglobin (HbA1c) less than or equal to (\<=)10.0 percent (%) (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening. * Treatment with lifestyle intervention or treatment with metformin according to local label. * Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening. Key exclusion criteria: * Treatment with any medication prescribed for obesity or weight management within 90 days before screening. * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: * 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. * Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed \>1 year before screening. * Uncontrolled thyroid disease. * Endocrine, hypothalamic, or syndromic obesity. * A self-reported (or by parent(s)/LAR, where applicable) change in body weight \> 5 % within 90 days before screening irrespective of medical records. * Type 1 diabetes or monogenic diabetes. For participants without T2D at screening the following exclusion criteria also apply * HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening. * Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening. For participants with T2D at screening the following exclusion criteria also apply * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire. * Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator. * Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. * Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study sites (34)

CA

FL

GA

ID

IN

KS

LA

MD

MN

ND

NY

OH

OK

PA

SC

SD

TN

TX

UT