Trial · Interventional
RecruitingPhase 3Registry dataA 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
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
- Ph 3
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Change in waist circumference
Time frame · From baseline (week 0) to end of double-blinded treatment (week 26)
Registry description
Measured as centimetre (cm).
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.
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).
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
PepBank is a research reference. Talk to a doctor before you use any peptide.