LivingGLP1
Study S001354

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity

Registration

Registration
NCT05646706
Acronym
STEP UP
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
1407
Start
2023-01-04
Primary completion
2024-10-30
Lead sponsor
Novo Nordisk A/S
Conditions
Obesity
Interventions
DRUG:Semaglutide; DRUG:Placebo
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1274-4259; EUDRACT_NUMBER:2022-000790-94

Registered primary outcomes

  • Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight [Baseline (week 0), End of treatment (week 72)]
  • Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) [At week 72]

Linked records (4)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0012383Effect of Semaglutide on Thigh Skeletal Muscle Volume, Fat Infiltration and Physical Function in People With Obesity: Secondary Analysis of STEP UP.
Hjelmesæth J, Diabetes, obesity & metabolism
2026Randomized trialPMID 42764399DOIcites ClinicalTrials.gov:NCT05646706; registry reference DERIVED:42764399
R00530222829-LB: STEP UP T2D: Participants Achieving BMI, WHtR, and Cardiometabolic Treatment Targets
CAREL LE ROUX, Diabetes
2026Other trialDOIcites ClinicalTrials.gov:NCT05646706
R0016489Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial.
Wharton S, The lancet. Diabetes & endocrinology
2025Randomized trialPMID 40961952DOIcites ClinicalTrials.gov:NCT05646706; registry reference DERIVED:40961952
R00380361966-LB: Efficacy and Safety of Semaglutide 7.2 mg in Obesity—STEP UP Trial
Sean Wharton, Diabetes
2025Randomized trialDOIcites ClinicalTrials.gov:NCT05646706