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
- Overweight
- Obesity
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Novo Nordisk A/S
- Enrolment target
- 460
- Started
- 8 January 2026
- Main results due (estimated)
- 20 March 2030
- Study ends (estimated)
- 20 September 2033
- Allocation
- Randomized
- Design
- Parallel
- Purpose
- Treatment
- Masking
- Quadruple (participant, care provider, investigator, outcomes assessor)
- Sites
- 121 · 9 in India
- First posted
- 28 November 2025
- Registry updated
- 30 September 2026
Sponsor staff involved in the clinical trial is masked according to company standard procedures. The main phase of the study is double blinded and followed by an open label extension phase.
Can you take part?
- Ages 8 years to 18 years.
- Open to any sex.
- You need the condition being studied. Healthy volunteers are not accepted.
Age groups: child, adult.
These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
What participants receive
- 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.
Drug: Cagrilintide · Drug: Semaglutide · Drug: Placebo cagrilintide · Drug: Placebo semaglutide
- 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.
Drug: Semaglutide · Drug: Placebo semaglutide
- 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.
Drug: Cagrilintide · Drug: Placebo cagrilintide
- 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.
Drug: Placebo cagrilintide · Drug: Placebo semaglutide
Interventions
CagrilintideDrug
Participants will receive cagrilintide subcutaneously.
SemaglutideDrug
Participants will receive semaglutide subcutaneously.
Placebo cagrilintideDrug
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutideDrug
Participants will receive placebo matched to semaglutide subcutaneously.
What the study measures
Primary outcomes
Relative change in body mass index (BMI)
Measured in percentage (%).
Time frame: Baseline (week 0), week 68
Secondary outcomes
Relative change in body weight
Measured in %.
Time frame: Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS)
Measured as SDS score.
Time frame: Baseline (week 0), week 68
Relative change in BMI
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Number of participants in weight category reduction
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=5% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved normal BMI
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who shifted from obese to non-obese BMI class
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Change in waist circumference
Measured in centimeter (cm).
Time frame: Baseline (week 0), week 68 and week 224
Change in waist-to-height ratio
Measured as ratio.
Time frame: Baseline (week 0), week 68
Absolute change in total fat mass by dual energy X-ray absorption (DXA)
Measured in kilograms (kg).
Time frame: Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA
Measured in %.
Time frame: Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA
Measured in % points.
Time frame: Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA
Measured in kg.
Time frame: Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA
Measured in %.
Time frame: Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA
Measured in % points.
Time frame: Baseline (week 0), week 68
Absolute change in lean body mass by DXA
Measured in kg.
Time frame: Baseline (week 0), week 68
Relative to total body mass change in lean body mass by DXA
Measured in % points.
Time frame: Baseline (week 0), week 68
Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat
Measured in liters (L).
Time frame: Baseline (week 0), week 68 and week 224
Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
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
Measured in % points.
Time frame: Baseline (week 0), week 68 and week 224
Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Measured in liters.
Time frame: Baseline (week 0), week 68 and week 224
Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat
Measured in liters.
Time frame: Baseline (week 0), week 68 and week 224
Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Change in BMI percentage of the 95th percentile
Measured in % points.
Time frame: Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Measured as ratio.
Time frame: Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Triglycerides
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Non-HDL cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT)
Measured in Units per Liter (U/L).
Time frame: Baseline (week 0), week 68 and week 224
Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Time frame: Baseline (week 0), week 68 and week 224
Change in diastolic blood pressure
Measured in mmHg.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by ultrasonographic methods
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Change in glycated haemoglobin (HbA1c) (% points)
Measured in % points.
Time frame: Baseline (week 0), week 68 and week 224
Change in HbA1c (millimoles per mole [mmol/mol])
Measured in mmol/mol.
Time frame: Baseline (week 0), week 68 and week 224
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Measured in mmol/L.
Time frame: Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL])
Measured in mg/dL.
Time frame: Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
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
Measured as count of participants.
Time frame: At week 68
Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 %
Measured as count of participants.
Time frame: At week 68
Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5%
Measured as count of participants.
Time frame: At week 68
Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%
Measured as count of participants.
Time frame: At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants taking antihypertensive medication at baseline, stop or decrease
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants taking lipid lowering medication at baseline, stop or decrease
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score
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).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Body esteem domain score
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).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Social life domain score
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).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Family-relations score
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).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Total score
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).
Time frame: Baseline (week 0), week 68 and week 224
Control of Eating Questionnaire (COEQ)
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.
Time frame: Baseline (week 0), week 68 and week 224
Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH)
Measured as counts.
Time frame: Baseline (week 0), week 68 and week 224
Number of treatment-emergent adverse events (TEAEs)
Measured as count of events.
Time frame: Baseline (week 0), week 68 and week 224
Number of treatment-emergent serious adverse events (TESAEs)
Measured as count of events.
Time frame: Baseline (week 0), week 68 and week 224
Number of treatment-emergent hypoglycaemic episodes
Measured as count of events.
Time frame: Baseline (week 0), week 68 and week 224
Change in pulse rate
Measured in beats per minute (beats/min).
Time frame: Baseline (week 0), week 68
Change in calcitonin
Measured in nanograms per liter (ng/L).
Time frame: Baseline (week 0), week 68
Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state
Measured in liters per hour (L/h).
Time frame: Baseline (week 0), week 68
Average concentration (Cavg) of semaglutide and cagrilintide at steady state
Measured in nanomoles per liter (nmol/L).
Time frame: Baseline (week 0), week 68
Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide
Measured in hours nanomoles per liter (h·nmol/L).
Time frame: Baseline (week 0), week 68
Who is running it
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry
- Responsible party
- The sponsor
- Organisation
- Novo Nordisk A/S
- Data monitoring committee
- No
- US FDA-regulated drug
- Yes
- US FDA-regulated device
- No
- Sponsor's study ID
- NN9838-4968
- Other IDs
- U1111-1299-4751, 2023-509176-42, 2023
Clinical Transparency (dept. 2834)
Study director
Novo Nordisk A/S
Study sites(121)
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Not yet recruiting
BAPS Pramukh Swami Hospital
Surat, Gujarat, India
Not yet recruiting
Indira Gandhi Institute of child health
Bangalore, Karnataka, India
Not yet recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Not yet recruiting
Maulana Azad Medical College
Delhi, New Delhi, India
Not yet recruiting
Regency Hospital
Kanpur, Uttar Pradesh, India
Not yet recruiting
Institute of Child Health
Kolkata, West Bengal, India
Not yet recruiting
Excel Endocrine Centre
Kolhāpur, India
Not yet recruiting
All India Institute of Medical Sciences (AIIMS)
New Delhi, India
Not yet recruiting
Neighborhood Healthcare
Escondido, California, United States
Recruiting
Encore Medical Research LLC
Hollywood, Florida, United States
Recruiting
Jacksonville Ctr for Clin Res
Jacksonville, Florida, United States
Recruiting
Encore Medical Research of Weston
Weston, Florida, United States
Recruiting
Children's Healthcare Atlanta
Atlanta, Georgia, United States
Recruiting
Columbus Research Foundation
Columbus, Georgia, United States
Recruiting
Accel Research Sites-NeuroStudies
Decatur, Georgia, United States
Recruiting
Eastside Bariatric and Gen Surg
Snellville, Georgia, United States
Recruiting
Solaris Clinical Research
Meridian, Idaho, United States
Recruiting
IU Health - Riley Physicians Endo-Diab
Indianapolis, Indiana, United States
Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Recruiting
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States
Recruiting
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States
Recruiting
Synexus Clinical Research US-MN
Richfield, Minnesota, United States
Recruiting
SUNY Upstate Medical Univ - Syracuse
Syracuse, New York, United States
Recruiting
Valley Weight Loss Clinic
Fargo, North Dakota, United States
Recruiting
Centricity Research - Ohio
Columbus, Ohio, United States
Recruiting
PriMed Clinical Research
Dayton, Ohio, United States
Recruiting
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States
Recruiting
LifeDoc Health
Memphis, Tennessee, United States
Recruiting
DM Clinical
Houston, Texas, United States
Recruiting
The Texas Liver Institute
San Antonio, Texas, United States
Recruiting
Pinnacle Clinical Research
San Antonio, Texas, United States
Recruiting
Consano Clin Res-Shavano Park
Shavano Park, Texas, United States
Recruiting
Texas Valley Clinical Research
Weslaco, Texas, United States
Recruiting
AMR Clinical
Layton, Utah, United States
Recruiting
The Children's Hospital at Westmead - Clinical Research Centre
Westmead, New South Wales, Australia
Recruiting
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Recruiting
Perth Children's Hospital
Nedlands, Western Australia, Australia
Recruiting
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck, Austria
Recruiting
Showing 40 of 121 sites, filter to narrow it down. 65 of 121 on this study are recruiting right now, and 9 are in India. A site can stop enrolling while the study as a whole is still open.
References and data sharing
- Participant data shared
- Yes
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.
Source: ClinicalTrials.gov record NCT07253285, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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