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HomeTrials › NCT07253285

Obesity & weight · Phase 3 · Recruiting now

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

NCT07253285 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is recruiting now at 34 US sites. It's studying Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide for overweight, obesity.

Who can joinAll sexes, 8 Years – 18 Years
Healthy volunteersNo — diagnosis required
What you'd takeCagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
Study length~4.2 years overall
Planned participants460
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 by state

California

  • Neighborhood Healthcare — Escondido · Opening soon

Florida

  • Encore Medical Research LLC — Hollywood · Recruiting now
  • Jacksonville Ctr for Clin Res — Jacksonville · Opening soon
  • Encore Medical Research of Weston — Weston · Recruiting now

Georgia

  • Children's Healthcare Atlanta — Atlanta · Recruiting now
  • Columbus Research Foundation — Columbus · Recruiting now
  • Accel Research Sites-NeuroStudies — Decatur · Recruiting now
  • Eastside Bariatric and Gen Surg — Snellville · Recruiting now

Idaho

  • Solaris Clinical Research — Meridian · Opening soon

Indiana

  • IU Health - Riley Physicians Endo-Diab — Indianapolis · Recruiting now

Kansas

  • Cotton O'Neil Clinical Research Center — Topeka · Opening soon

Louisiana

  • Pennington Biomed Res Ctr — Baton Rouge · Recruiting now

Maryland

  • Barry J. Reiner, MD LLC — Baltimore · Opening soon

Minnesota

  • University of Minnesota — Minneapolis · Recruiting now
  • AES Minneapolis DRS — Richfield · Opening soon

New York

  • UBMD Physicians Group - Pediatrics - Conventus — Buffalo · Opening soon
  • SUNY Upstate Medical Univ - Syracuse — Syracuse · Opening soon
  • Advantage Clinical Trials — The Bronx · Opening soon

North Dakota

  • Valley Weight Loss Clinic — Fargo · Opening soon

Ohio

  • Centricity Research - Ohio — Columbus · Opening soon
  • PriMed Clinical Research — Dayton · Opening soon

Oklahoma

  • Children's Physicians OU — Oklahoma City · Opening soon

Pennsylvania

  • UPMC Child Hosp-Pittsburgh — Pittsburgh · Opening soon

South Carolina

  • Prisma Health-Ped Endo — Greenville · Opening soon
  • Coastal Carolina Research Ctr — North Charleston · Opening soon

South Dakota

  • Monument Health Clinical Rsrch — Rapid City · Opening soon

Tennessee

  • LifeDoc Health — Memphis · Opening soon

Texas

  • DM Clinical — Houston · Recruiting now
  • DM Clinical — San Antonio · Opening soon
  • The Texas Liver Institute — San Antonio · Opening soon
  • Pinnacle Clinical Research — San Antonio · Opening soon
  • Consano Clin Res-Shavano Park — Shavano Park · Opening soon
  • Texas Valley Clinical Research — Weslaco · Opening soon

Utah

  • Wee Care Pediatrics — Syracuse · Opening soon

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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