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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name REIMAGINEYOUNG

NCTNCT07282613 (opens ClinicalTrials.gov in a new tab)Other idNN9388-7988Other idU1111-1307-6786Other id2024-514432-24

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
80 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
10 countries

United States, Argentina, Brazil, Colombia, India, Israel, Malaysia, Mexico, Taiwan, Thailand

Start
4 Aug 2026
Primary completion
7 Sept 2029 (estimated)
Completion
30 Mar 2030 (estimated)
First posted
15 Dec 2025
Last update posted
9 Sept 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028202920302031
  1. Ph 3

    REIMAGINEYOUNG

    NCT07282613

    4 Aug 2026 to est. 30 Mar 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • CagriSema (Cagrilintide B and Semaglutide I)Drug
  • Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)Drug

Arms3

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in glycated haemoglobin (HbA1c)

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

    Registry description

    Measured as percentage (%) of HbA1c.

Secondary outcomes(20)
  1. Relative change in body mass index (BMI)

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

    Registry description

    Measured as percentage.

  2. 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)

    Registry description

    Measured as count of participants.

  3. 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)

    Registry description

    Measured as count of participants.

  4. 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)

    Registry description

    Measured as percentage of time.

  5. 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)

    Registry description

    Measured as percentage of time.

  6. 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)

    Registry description

    Measured as percentage of time.

  7. 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)

    Registry description

    Measured as percentage of time.

  8. 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)

    Registry description

    Measured as mmol/L.

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

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

    Registry description

    Measured as percentage.

  10. Number of participants with incidence of glycaemic rescue therapy

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

    Registry description

    Measured as count of participants

  11. Change in fasting plasma glucose

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

    Registry description

    Measured as mmol/L.

  12. 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)

    Registry description

    Measured as count of participants.

  13. Number of participants with achievement of ≥ 10% BMI reduction

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

    Registry description

    Measured as count of participants.

  14. Number of participants with achievement of ≥ 15% BMI reduction

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

    Registry description

    Measured as count of participants.

  15. Relative change in body weight

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

    Registry description

    Measured as percentage of body weight.

  16. Change in BMI standard deviation score (SDS)

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

    Registry description

    Measured as score on scale.

  17. Change in waist circumference

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

    Registry description

    Measured as centimetre (cm).

  18. Change in waist-to-height ratio

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

    Registry description

    Measured as ratio.

  19. Change in systolic blood pressure

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

    Registry description

    Measured as millimetre of mercury (mmHg).

  20. Change in diastolic blood pressure

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

    Registry description

    Measured as mmHg.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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