This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
460
Participants will receive cagrilintide subcutaneously.
Participants will receive semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
Neighborhood Healthcare
Escondido, California, United States
NOT_YET_RECRUITINGEncore Medical Research LLC
Hollywood, Florida, United States
RECRUITINGJacksonville Ctr for Clin Res
Jacksonville, Florida, United States
NOT_YET_RECRUITINGEncore Medical Research of Weston
Weston, Florida, United States
Relative change in body mass index (BMI)
Measured in percentage (%).
Time frame: Baseline (week 0), week 68
Relative change in body weight
Measured in %.
Time frame: Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS)
Measured as SDS score.
Time frame: Baseline (week 0), week 68
Relative change in BMI
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Number of participants in weight category reduction
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of body weight (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=5% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of BMI (yes/no)
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who achieved normal BMI
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants who shifted from obese to non-obese BMI class
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Change in waist circumference
Measured in centimeter (cm).
Time frame: Baseline (week 0), week 68 and week 224
Change in waist-to-height ratio
Measured as ratio.
Time frame: Baseline (week 0), week 68
Absolute change in total fat mass by dual energy X-ray absorption (DXA)
Measured in kilograms (kg).
Time frame: Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA
Measured in %.
Time frame: Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA
Measured in % points.
Time frame: Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA
Measured in kg.
Time frame: Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA
Measured in %.
Time frame: Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA
Measured in % points.
Time frame: Baseline (week 0), week 68
Absolute change in lean body mass by DXA
Measured in kg.
Time frame: Baseline (week 0), week 68
Relative to total body mass change in lean body mass by DXA
Measured in % points.
Time frame: Baseline (week 0), week 68
Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat
Measured in liters (L).
Time frame: Baseline (week 0), week 68 and week 224
Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Change in ectopic fat content by MRI - liver fat MRI-Proton Density Fat Fraction (MRI-PDFF), pancreatic fat, kidney fat and thigh muscle fat infiltration
Measured in % points.
Time frame: Baseline (week 0), week 68 and week 224
Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Measured in liters.
Time frame: Baseline (week 0), week 68 and week 224
Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat
Measured in liters.
Time frame: Baseline (week 0), week 68 and week 224
Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat
Measured in %.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Change in BMI percentage of the 95th percentile
Measured in % points.
Time frame: Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Measured as ratio.
Time frame: Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Triglycerides
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Non-HDL cholesterol
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT)
Measured in Units per Liter (U/L).
Time frame: Baseline (week 0), week 68 and week 224
Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Time frame: Baseline (week 0), week 68 and week 224
Change in diastolic blood pressure
Measured in mmHg.
Time frame: Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by ultrasonographic methods
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Change in glycated haemoglobin (HbA1c) (% points)
Measured in % points.
Time frame: Baseline (week 0), week 68 and week 224
Change in HbA1c (millimoles per mole [mmol/mol])
Measured in mmol/mol.
Time frame: Baseline (week 0), week 68 and week 224
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Measured in mmol/L.
Time frame: Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL])
Measured in mg/dL.
Time frame: Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin
Measured as ratio.
Time frame: Baseline (week 0), week 68 and week 224
Number of participants with prediabetes who achieved HbA1c less than (<) 5.7% (defined as 5.7 % less than or equal to [<=] HbA1c <6.5 %) at baseline
Measured as count of participants.
Time frame: At week 68
Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 %
Measured as count of participants.
Time frame: At week 68
Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5%
Measured as count of participants.
Time frame: At week 68
Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%
Measured as count of participants.
Time frame: At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants taking antihypertensive medication at baseline, stop or decrease
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Number of participants taking lipid lowering medication at baseline, stop or decrease
Measured as count of participants.
Time frame: Baseline (week 0), week 68
Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Body esteem domain score
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Social life domain score
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Family-relations score
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).
Time frame: Baseline (week 0), week 68 and week 224
IWQOL Kids - Total score
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).
Time frame: Baseline (week 0), week 68 and week 224
Control of Eating Questionnaire (COEQ)
Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
Time frame: Baseline (week 0), week 68 and week 224
Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH)
Measured as counts.
Time frame: Baseline (week 0), week 68 and week 224
Number of treatment-emergent adverse events (TEAEs)
Measured as count of events.
Time frame: Baseline (week 0), week 68 and week 224
Number of treatment-emergent serious adverse events (TESAEs)
Measured as count of events.
Time frame: Baseline (week 0), week 68 and week 224
Number of treatment-emergent hypoglycaemic episodes
Measured as count of events.
Time frame: Baseline (week 0), week 68 and week 224
Change in pulse rate
Measured in beats per minute (beats/min).
Time frame: Baseline (week 0), week 68
Change in calcitonin
Measured in nanograms per liter (ng/L).
Time frame: Baseline (week 0), week 68
Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state
Measured in liters per hour (L/h).
Time frame: Baseline (week 0), week 68
Average concentration (Cavg) of semaglutide and cagrilintide at steady state
Measured in nanomoles per liter (nmol/L).
Time frame: Baseline (week 0), week 68
Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide
Measured in hours nanomoles per liter (h·nmol/L).
Time frame: Baseline (week 0), week 68
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