Effect and safety of liraglutide 3.0 mg on weight management in children with obesity aged 6 to <12 years: 56-week, double-blind, randomised, placebo-controlled trial

Conditions

Obesity

Brief summary

Relative change in BMI, from basekline (week 0) to week 56, in Percent

Detailed description

Confirmatory secondary endpoints: Relative change in body weight, from week 0 to week 56 in Percent, Subjects achieving ≥5% reduction of BMI, from week 0 to week 56 in, Yes/No, Supportive secondary endpoints Effect endpoints: Change in body weight, From baseline (week 0) to week 56, in kg, Change in BMI standard deviation score (WHO.int)6, From baseline (week 0) to week 56, Unitless, Subjects achieving ≥10% reduction of BMI, From baseline (week 0) to week 56, Yes/No, "BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov), From baseline (week 0) to week 56, in Percent point", Change in waist circumference, From baseline (week 0) to week 56, in cm, Change in systolic blood pressure, From baseline (week 0) to week 56, in mmHg, Change in diastolic blood pressure, From baseline (week 0) to week 56, in mmHg, Change in HbA1c, From baseline (week 0) to week 56, in Percent point, Safety endpoints: Treatment emergent adverse events (TEAEs), From baseline (week 0) to week 82, in Numbers, Treatment emergent serious adverse events (SAEs), From baseline (week 0) to week 82, in Numbers

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGLiraglutide placebo

DRUGSaxenda 6 mg/mL solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Relative change in BMI, from basekline (week 0) to week 56, in Percent	—

Secondary

Measure	Time frame
Confirmatory secondary endpoints: Relative change in body weight, from week 0 to week 56 in Percent, Subjects achieving ≥5% reduction of BMI, from week 0 to week 56 in, Yes/No, Supportive secondary endpoints Effect endpoints: Change in body weight, From baseline (week 0) to week 56, in kg, Change in BMI standard deviation score (WHO.int)6, From baseline (week 0) to week 56, Unitless, Subjects achieving ≥10% reduction of BMI, From baseline (week 0) to week 56, Yes/No, "BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov), From baseline (week 0) to week 56, in Percent point", Change in waist circumference, From baseline (week 0) to week 56, in cm, Change in systolic blood pressure, From baseline (week 0) to week 56, in mmHg, Change in diastolic blood pressure, From baseline (week 0) to week 56, in mmHg, Change in HbA1c, From baseline (week 0) to week 56, in Percent point, Safety endpoints: Treatment emergent adverse events (TEAEs), From baseline (week	—

Measure

Time frame

Confirmatory secondary endpoints: Relative change in body weight, from week 0 to week 56 in Percent, Subjects achieving ≥5% reduction of BMI, from week 0 to week 56 in, Yes/No, Supportive secondary endpoints Effect endpoints: Change in body weight, From baseline (week 0) to week 56, in kg, Change in BMI standard deviation score (WHO.int)6, From baseline (week 0) to week 56, Unitless, Subjects achieving ≥10% reduction of BMI, From baseline (week 0) to week 56, Yes/No, "BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov), From baseline (week 0) to week 56, in Percent point", Change in waist circumference, From baseline (week 0) to week 56, in cm, Change in systolic blood pressure, From baseline (week 0) to week 56, in mmHg, Change in diastolic blood pressure, From baseline (week 0) to week 56, in mmHg, Change in HbA1c, From baseline (week 0) to week 56, in Percent point, Safety endpoints: Treatment emergent adverse events (TEAEs), From baseline (week

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Countries

Belgium, Portugal

Outcome results

None listed