REIMAGINEYOUNG

Not yet recruitingPhase 3

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

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07282613

Org study IDNN9388-7988

Secondary ID2024-514432-24European Medical Agency (EMA)

Secondary IDU1111-1307-6786World Health Organization (WHO)

Timeline

Milestones

Study first posted2025-12-15actual

Last update posted2026-05-28actual

Study start2026-08-04estimated

Primary completion2029-09-07estimated

Study completion2030-03-30estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

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.

Endpoints (53)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

MASH / liver

Renal / kidney

Weight & body composition

10 endpoints

Secondary/protocol endpoint

Relative change in body mass index (BMI)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of participants with achievement of greater than or equal to (≥) 5% BMI reduction

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants with achievement of ≥ 10% BMI reduction

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants with achievement of ≥ 15% BMI reduction

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI standard deviation score (SDS)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-height ratio

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Secondary/protocol endpoint

Height velocity

Time frame:At end of double-blinded treatment (week 26)

change from baseline, descriptive

Secondary/protocol endpoint

Change in height SDS

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

change from baseline, descriptive

Glycemic / diabetes

20 endpoints

Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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)

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

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)

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

CGM: Within-day glycaemic variability (% coefficient of variation)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

percent change from baseline, improvement

Secondary/protocol endpoint

Number of participants with incidence of glycaemic rescue therapy

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

threshold achievement, event

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change in insulin dose

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

change from baseline, improvement

Secondary/protocol endpoint

Number of participants with achievement of sustained insulin dose = 0 U

Time frame:At end of double-blinded treatment (week 26)

threshold achievement, improvement

Secondary/protocol endpoint

Ratio to baseline in biomarker related to glucose metabolism: fasting C-peptide

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Secondary/protocol endpoint/low confidence

Ratio to baseline in biomarker related to glucose metabolism: fasting insulin

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Secondary/protocol endpoint/low confidence

Ratio to baseline in biomarker related to glucose metabolism: fasting proinsulin

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in biomarker related to glucose metabolism: fasting glucagon

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:From baseline (week 0) to end of extension phase treatment (week 52)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in percentage of time below range (TBR) < 3.0 mmol/L (< 54 mg/dL) measured using CGM

Time frame:At end of double-blinded treatment (collected during week 22, 23, 24, and 25)

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

Change in TBR < 3.9 mmol/L (< 70 mg/dL) measured using CGM

Time frame:At end of double-blinded treatment (collected during week 22, 23, 24, and 25)

CGM time-below-range

change from baseline, improvement

MASH / liver

4 endpoints

Secondary/protocol endpoint

Change in alanine aminotransferase (ALT)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in aspartate aminotransferase (AST)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change in alkaline phosphatase (ALP)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in bilirubin

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Ratio to baseline in urine albumin-creatinine ratio (UACR)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

13 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to baseline in lipid: total cholesterol

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline in lipid: high density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to baseline in lipid: low density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline in lipid: very low density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipid: triglycerides

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline in lipid: Non-HDL cholesterol

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (week 0) to end of double- blinded treatment (week 26)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ratio to baseline in free fatty acids

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in leptin

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Leptin, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in soluble leptin receptor

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in leptin to soluble leptin receptor ratio

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

ratio, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Apparent clearance (CL/F) of cagrilintide and semaglutide

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

descriptive

Secondary/protocol endpoint

Average concentration (Cavg) of cagrilintide and semaglutide at steady state

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL) confirmed by blood glucose [BG] meter)

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of severe hypoglycaemic episodes (level 3) - severe hypoglycaemia being defined as severe cognitive impairment requiring assistance by another person to administer carbohydrates, glucagon, or intravenous glucose

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of treatment-emergent adverse events

Time frame:From baseline (week 0) to end of double-blinded treatment (week 26)

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.