Current partner codePEPTIDESDE
NCT07282613·Phase 3·INTERVENTIONAL

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes

Status

Not yet recruiting

Phase

Phase 3

Enrollment

80

Locations

56

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

CagriSema (Cagrilintide B and Semaglutide I)

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

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Dec 15, 2025

  2. Study start

    Aug 4, 2026

  3. Primary completion

    Sep 7, 2029

  4. Study completion

    Mar 30, 2030

  5. Results posted

    Not reported

  6. Registry updated

    May 28, 2026

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
10 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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

56 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.