Recruiting
Phase 3

CagriSema & Cagrilintide

Sponsor:

Novo Nordisk A/S

Code:

NCT07253285

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Cagrilintide

Semaglutide

Placebo cagrilintide

Placebo semaglutide

Study Details

Brief summary:

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.

Conditions

Overweight

Obesity

Study ID

NCT07253285

Start date

Jan 8, 2026

Status verified date

Aug, 2026

Completion date

Sep 20, 2033

Anticipated

Primary completion date

Mar 20, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Cagrilintide

Participants will receive cagrilintide subcutaneously.

Semaglutide

Participants will receive semaglutide subcutaneously.

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Primary outcome measure

  • Relative change in body mass index (BMI) [ Time Frame: Baseline (week 0), week 68 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Neighborhood Healthcare

Recruiting

Escondido, California, United States, 92025

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

Jacksonville Ctr for Clin Res

Recruiting

Jacksonville, Florida, United States, 32216

Encore Medical Research of Weston

Recruiting

Weston, Florida, United States, 33331

Children's Healthcare Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Columbus Research Foundation

Recruiting

Columbus, Georgia, United States, 31904

Accel Research Sites-NeuroStudies

Recruiting

Decatur, Georgia, United States, 30030

Eastside Bariatric and Gen Surg

Recruiting

Snellville, Georgia, United States, 30078

Solaris Clinical Research

Recruiting

Meridian, Idaho, United States, 83646

IU Health - Riley Physicians Endo-Diab

Recruiting

Indianapolis, Indiana, United States, 46202

Cotton O'Neil Clinical Research Center

Recruiting

Topeka, Kansas, United States, 66606

Pennington Biomed Res Ctr

Recruiting

Baton Rouge, Louisiana, United States, 70808-4124

Barry J. Reiner, MD LLC

Recruiting

Baltimore, Maryland, United States, 21229

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Synexus Clinical Research US-MN

Recruiting

Richfield, Minnesota, United States, 55423

Valley Weight Loss Clinic

Recruiting

Fargo, North Dakota, United States, 58104

Centricity Research - Ohio

Recruiting

Columbus, Ohio, United States, 43213

PriMed Clinical Research

Recruiting

Dayton, Ohio, United States, 45429

Coastal Carolina Research Ctr

Recruiting

North Charleston, South Carolina, United States, 29405

LifeDoc Health

Recruiting

Memphis, Tennessee, United States, 38115

DM Clinical

Recruiting

Houston, Texas, United States, 77065

The Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Pinnacle Clinical Research

Recruiting

San Antonio, Texas, United States, 78222

Consano Clin Res-Shavano Park

Recruiting

Shavano Park, Texas, United States, 78231

Texas Valley Clinical Research

Recruiting

Weslaco, Texas, United States, 78596

AMR Clinical

Recruiting

Layton, Utah, United States, 84041

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-31.