LivingGLP1
parallel randomized trial

STEP 8

Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity

Overweight or obesity without diabetes (adults)NCT04074161S001600

Design

Randomized
338
Start year
2019
Treatment
68 weeks, follow-up 75 weeks
Countries
United States (19 sites)
Sponsor
Novo Nordisk A/S (industry)
Eligibility
age 18 or older; BMI 30 or higher, or 27 with a weight related comorbidity; no type 2 diabetes

Conduct and analysis

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

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Semaglutide 2.4 mg subcutaneous once weekly
Semaglutide 2.4 mg weekly
lifestyle: standard126117
A2Liraglutide 3.0 mg subcutaneous once daily
Liraglutide 3.0 mg daily
lifestyle: standard127117
A3Placebo
Pooled placebo
lifestyle: standard8578

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticSemaglutide 2.4 mg subcutaneous once weekly
A1
Liraglutide 3.0 mg subcutaneous once daily
A2
Placebo
A3
agemean (years)484951
agesd (years)141312
asiann463
blackn252019
femalen1029766
hispanicn15177
other race native hawaiian pacific islandern131
other race othern232
whiten949560

Analyses this trial contributes to

Results

52 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Systolic blood pressure change (3 lines; O05)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
68A1change-7 mmHg14114not stated; full analysis; registry:outcomes
68A2change-4 mmHg15112not stated; full analysis; registry:outcomes
68A3change5 mmHg1477not stated; full analysis; registry:outcomes
Percent body weight change (4 lines; O10)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
68A1percent change-16.4 percent10.5117not stated; full analysis; registry:outcomes
68A1 vs A2md-9.38 percent-11.97 to -6.80not stated; full analysis; registry:outcomes
68A2percent change-6.4 percent7.7117not stated; full analysis; registry:outcomes
68A3percent change-1.6 percent8.678not stated; full analysis; registry:outcomes
Weight loss of 10 percent or more (3 lines; O11B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
68A1responders83 / 117not stated; full analysis; registry:outcomes
68A2responders30 / 117not stated; full analysis; registry:outcomes
68A3responders12 / 78not stated; full analysis; registry:outcomes
Weight loss of 15 percent or more (3 lines; O11C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
68A1responders65 / 117not stated; full analysis; registry:outcomes
68A2responders14 / 117not stated; full analysis; registry:outcomes
68A3responders5 / 78not stated; full analysis; registry:outcomes
Weight loss of 20 percent or more (3 lines; O11D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
68A1responders45 / 117not stated; full analysis; registry:outcomes
68A2responders7 / 117not stated; full analysis; registry:outcomes
68A3responders2 / 78not stated; full analysis; registry:outcomes
Acute kidney injury (3 lines; O121)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 126not stated; safety; Acute kidney injury; registry:adverse_events
A2events0 / 127not stated; safety; Acute kidney injury; registry:adverse_events
A3events0 / 85not stated; safety; Acute kidney injury; registry:adverse_events
Progression to type 2 diabetes (3 lines; O14)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 110not stated; full analysis; registry:outcomes
A2events1 / 111not stated; full analysis; registry:outcomes
A3events3 / 77not stated; full analysis; registry:outcomes
All cause mortality (3 lines; O20)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 126not stated; safety; registry:adverse_events
A2events0 / 127not stated; safety; registry:adverse_events
A3events0 / 85not stated; safety; registry:adverse_events
Hospitalization for heart failure (3 lines; O23)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 126not stated; safety; Cardiac failure congestive; registry:adverse_events
A2events0 / 127not stated; safety; Cardiac failure congestive; registry:adverse_events
A3events1 / 85not stated; safety; Cardiac failure congestive; registry:adverse_events
Serious adverse events (3 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events10 / 126not stated; safety; registry:adverse_events
A2events14 / 127not stated; safety; registry:adverse_events
A3events6 / 85not stated; safety; registry:adverse_events
Nausea (3 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events77 / 126not stated; safety; registry:adverse_events
A2events75 / 127not stated; safety; registry:adverse_events
A3events19 / 85not stated; safety; registry:adverse_events
Vomiting (3 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events32 / 126not stated; safety; registry:adverse_events
A2events26 / 127not stated; safety; registry:adverse_events
A3events5 / 85not stated; safety; registry:adverse_events
Diarrhea (3 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events35 / 126not stated; safety; registry:adverse_events
A2events23 / 127not stated; safety; registry:adverse_events
A3events22 / 85not stated; safety; registry:adverse_events
Constipation (3 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events49 / 126not stated; safety; registry:adverse_events
A2events40 / 127not stated; safety; registry:adverse_events
A3events20 / 85not stated; safety; registry:adverse_events
Gallbladder and biliary disease (9 lines; O28)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 126not stated; safety; Cholelithiasis; registry:adverse_events
A1events0 / 126not stated; safety; Cholecystitis acute; registry:adverse_events
A1events0 / 126not stated; safety; Cholecystitis infective; registry:adverse_events
A2events1 / 127not stated; safety; Cholecystitis infective; registry:adverse_events
A2events1 / 127not stated; safety; Cholecystitis acute; registry:adverse_events
A2events1 / 127not stated; safety; Cholelithiasis; registry:adverse_events
A3events0 / 85not stated; safety; Cholecystitis acute; registry:adverse_events
A3events1 / 85not stated; safety; Cholelithiasis; registry:adverse_events
A3events0 / 85not stated; safety; Cholecystitis infective; registry:adverse_events