LivingGLP1
parallel randomized trial

NCT02496611

Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity

Design

Randomized
66
Start year
2015
Treatment
52 weeks, follow-up 52 weeks
Countries
Sponsor
University of Minnesota (not reported)
Eligibility
age 12 to below 18; BMI at least 120 percent of 95th percentile; at least 5 percent BMI loss on meal replacement

Conduct and analysis

Blinding
double blind
Sequence generation
not reported
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
randomized
Missing data
LOCF

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Placebo
Placebo plus lifestyle therapy
lifestyle therapy after meal replacement induction; lifestyle: not reported3333
A2Exenatide extended release 2 mg subcutaneous once weekly
Exenatide extended release 2 mg weekly plus lifestyle therapy
lifestyle therapy after meal replacement induction; lifestyle: not reported3333

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticPlacebo
A1
Exenatide extended release 2 mg subcutaneous once weekly
A2
Whole trial
ALL
agemean (years)16
agesd (years)1.5
bmimean (kg/m2)36.9
bmisd (kg/m2)4.4
femalen1318
hispanicn25

Analyses this trial contributes to

Results

16 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent BMI change (4 lines; O13B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
52A1percent change10.1 percent9.033not stated; randomized; registry:outcomes
52A2percent change4.6 percent10.533not stated; randomized; registry:outcomes
52A2 vs A1md-4.1 percent-8.6 to 0.5not stated; randomized; R0009976:Abstract
52A2 vs A1md-5.7 percent-10.9 to -0.6not stated; per protocol; R0009976:Abstract
All cause mortality (2 lines; O20)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 33not stated; randomized; registry:adverse_events
A2events0 / 33not stated; randomized; registry:adverse_events
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 33not stated; randomized; registry:adverse_events
A2events1 / 33not stated; randomized; registry:adverse_events
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events7 / 33not stated; randomized; registry:adverse_events
A2events13 / 33not stated; randomized; registry:adverse_events
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 33not stated; randomized; registry:adverse_events
A2events13 / 33not stated; randomized; registry:adverse_events
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events6 / 33not stated; randomized; registry:adverse_events
A2events11 / 33not stated; randomized; registry:adverse_events
Constipation (2 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events6 / 33not stated; randomized; registry:adverse_events
A2events6 / 33not stated; randomized; registry:adverse_events