DRUG
CagriSema (Cagrilintide B and Semaglutide I)
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Status
Not yet recruiting
Phase
Phase 3
Enrollment
80
Locations
56
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
DRUG
Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Timeline
First posted
Dec 15, 2025
Study start
Aug 4, 2026
Primary completion
Sep 7, 2029
Study completion
Mar 30, 2030
Results posted
Not reported
Registry updated
May 28, 2026
Outcomes
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of double-blinded treatment (week 26)
Measured as percentage (%) of HbA1c.
Relative change in body mass index (BMI)
Time frame · From baseline (week 0) to end of double-blinded treatment (week 26)
Measured as percentage.
Number of participants with achievement of HbA1c target values of less than (<) 7.0% (< 53 millimole per mole [mmol/mol])
Time frame · At end of double-blinded treatment (week 26)
Measured as count of participants.
Number of participants with achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤48 mmol/mol)
Time frame · At end of double-blinded treatment (week 26)
Measured as count of participants.
Change in time in range (TIR) 3.9-10.0 millimole per liter (mmol/L) (70-180 milligram per deciliter (mg/dL) measured using continuous glucose monitoring (CGM)
Time frame · From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Measured as percentage of time.
Change in time in tight target range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) measured using CGM
Time frame · From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Measured as percentage of time.
Change in time above range (TAR) greater than (>) 10.0 mmol/L (> 180 mg/dL) measured using CGM
Time frame · From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Measured as percentage of time.
Change in TAR greater than (>) 13.9 mmol/L (> 250 mg/dL) measured using CGM
Time frame · From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Measured as percentage of time.
Change in mean sensor glucose concentration measured by CGM
Time frame · From baseline (collected during week -3, -2 and -1) to end-of- double-blinded treatment (collected during week 22, 23, 24, and 25)
Measured as mmol/L.
CGM: Within-day glycaemic variability (% coefficient of variation)
Time frame · From baseline (week 0) to end of double-blinded treatment (week 26)
Measured as percentage.
Number of participants with incidence of glycaemic rescue therapy
Time frame · From baseline (week 0) to end of double-blinded treatment (week 26)
Measured as count of participants
Eligibility
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 locations
Argentina · Brazil · Colombia · India · Israel · Malaysia · Mexico · Taiwan · Thailand · United States. Showing up to 24 locations stored in the fast local snapshot.
Yale School of Medicine
New Haven, Connecticut, United States
Encore Medical Research Boynton Beach
Boynton Beach, Florida, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, United States
Innovus Clinical
Kissimmee, Florida, United States
D&H National Research Centers
Tamarac, Florida, United States
Clinical Research Trials of Florida
Tampa, Florida, United States
Columbus Research Foundation
Columbus, Georgia, United States
Eastside Bariatric and Gen Surg
Snellville, Georgia, United States
SIU Medicine
Springfield, Illinois, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Great Lakes Research Inst.
Southfield, Michigan, United States
UBMD Pediatrics
Buffalo, New York, United States
NYU Langone Orthopedic Center
New York, New York, United States
Children's Hosptl Philadelphia
Philadelphia, Pennsylvania, United States
Monument Health Clinical Rsrch
Rapid City, South Dakota, United States
LifeDoc Health
Memphis, Tennessee, United States
Amir Ali Hassan, MD, PA
Houston, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
UVA Health Systems
Charlottesville, Virginia, United States
Seattle Children's Research Institute
Seattle, Washington, United States
Centro de Investigaciones Metabólicas
Capital Federal, Buenos Aires, Argentina
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
San Miguel de Tucumán, Tucumán Province, Argentina
IMOBA
City of Buenos Aires, Argentina
Publications
No PMID-linked publications were present in this registry snapshot.
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