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NCT Number: NCT07253285

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Children's Hospital at Westmead - Clinical Research Centre, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cagrilintide

Drug

Participants will receive cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Placebo Cagrilintide

Drug

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo Semaglutide

Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Primary outcomes

  1. Relative change in body mass index (BMI)

    Time frame: Baseline (week 0), week 68

    Measured in percentage (%).

Secondary outcomes

  1. Relative change in body weight

    Time frame: Baseline (week 0), week 68

    Measured in %.

  2. Change in BMI Standard Deviation Score (SDS)

    Time frame: Baseline (week 0), week 68

    Measured as SDS score.

  3. Relative change in BMI

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in %.

  4. Number of participants in weight category reduction

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  5. 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

    Measured as count of participants.

  6. Number of participants who achieved >=10% reduction of body weight (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  7. Number of participants who achieved >=15% reduction of body weight (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  8. Number of participants who achieved >=20% reduction of body weight (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  9. Number of participants who achieved >=25% reduction of body weight (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  10. Number of participants who achieved >=5% reduction of BMI (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  11. Number of participants who achieved >=10% reduction of BMI (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  12. Number of participants who achieved >=15% reduction of BMI (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  13. Number of participants who achieved >=20% reduction of BMI (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  14. Number of participants who achieved >=25% reduction of BMI (yes/no)

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  15. Number of participants who achieved normal BMI

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  16. Number of participants who shifted from obese to non-obese BMI class

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  17. Change in waist circumference

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in centimeter (cm).

  18. Change in waist-to-height ratio

    Time frame: Baseline (week 0), week 68

    Measured as ratio.

  19. Absolute change in total fat mass by dual energy X-ray absorption (DXA)

    Time frame: Baseline (week 0), week 68

    Measured in kilograms (kg).

  20. Relative to baseline change in total fat mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in %.

  21. Relative to total body mass change in total fat mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in % points.

  22. Absolute change in visceral fat mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in kg.

  23. Relative to baseline change in visceral fat mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in %.

  24. Relative to total body mass change in visceral fat mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in % points.

  25. Absolute change in lean body mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in kg.

  26. Relative to total body mass change in lean body mass by DXA

    Time frame: Baseline (week 0), week 68

    Measured in % points.

  27. Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in liters (L).

  28. Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in %.

  29. Change in ectopic fat content by MRI - liver fat MRI-Proton Density Fat Fraction (MRI-PDFF), pancreatic fat, kidney fat and thigh muscle fat infiltration

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in % points.

  30. Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in liters.

  31. Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in %.

  32. Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in liters.

  33. Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in %.

  34. Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  35. Change in BMI percentage of the 95th percentile

    Time frame: Baseline (week 0), week 68

    Measured in % points.

  36. Ratio to baseline highly sensitive C-reactive protein (hs-CRP)

    Time frame: Baseline (week 0), week 68

    Measured as ratio.

  37. Ratio to baseline in lipids: Total cholesterol

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  38. Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  39. Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  40. Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  41. Ratio to baseline in lipids: Triglycerides

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  42. Ratio to baseline in lipids: Non-HDL cholesterol

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  43. Change in Alanine Transaminase (ALT)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in Units per Liter (U/L).

  44. Change in systolic blood pressure

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in millimeters of mercury (mmHg).

  45. Change in diastolic blood pressure

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in mmHg.

  46. Ratio to baseline in liver stiffness measured by ultrasonographic methods

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  47. Change in glycated haemoglobin (HbA1c) (% points)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in % points.

  48. Change in HbA1c (millimoles per mole [mmol/mol])

    Time frame: Baseline (week 0), week 68 and week 224

    Measured in mmol/mol.

  49. Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])

    Time frame: Baseline (week 0), week 68

    Measured in mmol/L.

  50. Change in FPG (milligrams per deciliter [mg/dL])

    Time frame: Baseline (week 0), week 68

    Measured in mg/dL.

  51. Ratio to baseline in fasting serum insulin

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as ratio.

  52. Number of participants with prediabetes who achieved HbA1c less than (<) 5.7% (defined as 5.7 % less than or equal to [<=] HbA1c <6.5 %) at baseline

    Time frame: At week 68

    Measured as count of participants.

  53. Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 %

    Time frame: At week 68

    Measured as count of participants.

  54. Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5%

    Time frame: At week 68

    Measured as count of participants.

  55. Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%

    Time frame: At week 68

    Measured as count of participants.

  56. Number of participants taking glucose lowering medication at baseline, stop or decrease

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  57. Number of participants taking antihypertensive medication at baseline, stop or decrease

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  58. Number of participants taking lipid lowering medication at baseline, stop or decrease

    Time frame: Baseline (week 0), week 68

    Measured as count of participants.

  59. Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).

  60. IWQOL Kids - Body esteem domain score

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).

  61. IWQOL Kids - Social life domain score

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).

  62. IWQOL Kids - Family-relations score

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).

  63. IWQOL Kids - Total score

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).

  64. Control of Eating Questionnaire (COEQ)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.

  65. Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as counts.

  66. Number of treatment-emergent adverse events (TEAEs)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as count of events.

  67. Number of treatment-emergent serious adverse events (TESAEs)

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as count of events.

  68. Number of treatment-emergent hypoglycaemic episodes

    Time frame: Baseline (week 0), week 68 and week 224

    Measured as count of events.

  69. Change in pulse rate

    Time frame: Baseline (week 0), week 68

    Measured in beats per minute (beats/min).

  70. Change in calcitonin

    Time frame: Baseline (week 0), week 68

    Measured in nanograms per liter (ng/L).

  71. Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state

    Time frame: Baseline (week 0), week 68

    Measured in liters per hour (L/h).

  72. Average concentration (Cavg) of semaglutide and cagrilintide at steady state

    Time frame: Baseline (week 0), week 68

    Measured in nanomoles per liter (nmol/L).

  73. Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide

    Time frame: Baseline (week 0), week 68

    Measured in hours nanomoles per liter (h·nmol/L).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2033
First posted
Nov 28, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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