Recruiting
Phase 3

CagriSema

Sponsor:

Novo Nordisk A/S

Code:

NCT07282613

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Study Details

Brief summary:

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07282613

Start date

Aug 4, 2026

Status verified date

Sep, 2026

Completion date

Mar 30, 2030

Anticipated

Primary completion date

Sep 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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.
  • Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening.
  • Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:

  • Insulin (any regimen)
  • Metformin
  • SGLT2i
  • HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening.
  • Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening.

  • (a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening.
  • (b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used.

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.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
  • Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment 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

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: CagriSema

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

placebo comparator: Part 1: Placebo

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

experimental: Part 2: CagriSema

Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2.

Interventions

CagriSema (Cagrilintide B and Semaglutide I)

Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Primary outcome measure

  • Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of double-blinded treatment (week 26) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Encore Medical Research Boynton Beach

Recruiting

Boynton Beach, Florida, United States, 33436

Nemours Chld Clnc Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Innovus Clinical

Recruiting

Kissimmee, Florida, United States, 34741

D&H National Research Centers

Recruiting

Tamarac, Florida, United States, 33321

Clinical Research Trials of Florida

Recruiting

Tampa, Florida, United States, 33607

Columbus Research Foundation

Recruiting

Columbus, Georgia, United States, 31904

Eastside Bariatric and Gen Surg

Recruiting

Snellville, Georgia, United States, 30078

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Great Lakes Research Inst.

Recruiting

Southfield, Michigan, United States, 48075

LifeDoc Health

Recruiting

Memphis, Tennessee, United States, 38115

Amir Ali Hassan, MD, PA

Recruiting

Houston, Texas, United States, 77089

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

UVA Health Systems

Recruiting

Charlottesville, Virginia, United States, 22903

Seattle Children's Research Institute

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-09.