Not yet recruiting · NCT07282613

A study testing whether a study medicine from Novo Nordisk, cagrisema, can lower blood sugar and help with weight.

Who can join
Children and teens 10 to 18, have type 2 diabetes.
What you take
cagrisema, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
How long it lasts
The full study runs about 3.6 years; your own time in it is usually shorter.
What you get
The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
Phase Phase 3Sponsor Novo Nordisk A/SDrug cagrisemaClass OtherSites 21 USEnrollment target 80

What this study is for

Full study title: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Di.

Primary condition: Diabetes Mellitus, Type 2.

Who can join, in detail

Age 10 to 18
Sex All

Key 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.
  • Age 10 to < 18 years at the time of signing the informed consent.

Key exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening.
  • Known or previous diagnosis of hypoparathyroidism.
  • Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening, (2) lap banding, if the band has been removed >1 year before screening, (3) intragastric balloon, if the balloon has been removed >1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening.
  • Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history.

Where this study is enrolling

This trial has 21 US sites across 14 states. Contact the site coordinator directly to start the screening process.

Connecticut

  • Yale School of Medicine
    New Haven, Connecticut

Florida

  • Encore Medical Research Boynton Beach
    Boynton Beach, Florida
  • Nemours Chld Clnc Jacksonville
    Jacksonville, Florida
  • Innovus Clinical
    Kissimmee, Florida
  • D&H National Research Centers
    Tamarac, Florida
  • Clinical Research Trials of Florida
    Tampa, Florida

Georgia

  • Columbus Research Foundation
    Columbus, Georgia
  • Eastside Bariatric and Gen Surg
    Snellville, Georgia

Illinois

  • SIU Medicine
    Springfield, Illinois

Indiana

  • Riley Hospital For Children
    Indianapolis, Indiana

Iowa

  • University of Iowa
    Iowa City, Iowa

Michigan

  • Great Lakes Research Inst.
    Southfield, Michigan

New York

  • UBMD Pediatrics
    Buffalo, New York
  • NYU Langone Orthopedic Center
    New York, New York

Pennsylvania

  • Children's Hosptl Philadelphia
    Philadelphia, Pennsylvania

South Dakota

  • Monument Health Clinical Rsrch
    Rapid City, South Dakota

Tennessee

  • LifeDoc Health
    Memphis, Tennessee

Texas

  • Amir Ali Hassan, MD, PA
    Houston, Texas
  • Consano Clinical Research, LLC
    Shavano Park, Texas

Virginia

  • UVA Health Systems
    Charlottesville, Virginia

Washington

  • Seattle Children's Research Institute
    Seattle, Washington

Timeline

Started enrolling: 2026-08-04. Expected completion: 2030-03-30. Last updated on ClinicalTrials.gov: 2026-05-28.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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