Study S001600

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

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04074161
Acronym: STEP 8
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 338
Start: 2019-09-11
Primary completion: 2021-03-27
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity
Interventions: DRUG:Semaglutide; DRUG:Placebo (semaglutide); DRUG:Liraglutide; DRUG:Placebo (liraglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1233-0977

Registered primary outcomes

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) [Baseline (week 0), week 68]

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.

Record	Title	Year	Design	Identifiers	Link basis
R0017898	Liraglutide for Children 6 to <12 Years of Age with Obesity. Malozowski S, The New England journal of medicine	2025	Other trial	PMID 40334165 DOI	cites ClinicalTrials.gov:NCT04074161
R0005829	Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Wharton S, Postgraduate medicine	2022	Other	PMID 34775881 DOI	registry reference RESULT:34775881
R0014535	Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. Rubino DM, JAMA	2022	Randomized trial	PMID 35015037 DOI	cites ClinicalTrials.gov:NCT04074161; registry reference RESULT:35015037
R0022313	Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial. Snitker S, Diabetes, obesity & metabolism	2022	Other trial	PMID 35791625 DOI	cites ClinicalTrials.gov:NCT04074161; registry reference DERIVED:35791625