Weight management · Phase 3
STEP 1: weight change without diabetes
What was tested?
Subcutaneous semaglutide versus placebo, alongside lifestyle intervention. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 68. ↗
What the reviewed report found
Journal year 2021 · Article summary reviewed 2026-08-18
Mean body-weight change at 68 weeks was -14.9% in the semaglutide group and -2.4% with placebo. Gastrointestinal events were common, and treatment discontinuation for gastrointestinal events was more frequent with semaglutide.↗
Keep in context: The study had two primary weight endpoints. Its results do not describe what happens after treatment is stopped. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 1,961 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2021-11-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
STEP 1 weight-management trial
- Design in the report
- A double-blind, randomized, placebo-controlled trial followed participants for 68 weeks alongside a lifestyle intervention.↗
- Participants in the report
- The trial enrolled 1,961 adults with obesity, or overweight plus at least one weight-related condition, who did not have diabetes.↗
- Limitations
- The sponsor-funded trial combined treatment with lifestyle intervention, excluded people with diabetes, and does not by itself establish outcomes after treatment stops.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity ↗
Protocol identifier: NN9536-4373. Sponsor: Novo Nordisk A/S.
Retrieved 2026-09-20; SHA-256 4e62d440f923ad478277cceea9082beffa9997d4c28e03ce8a747bc32a4c54ad.
PMID 33567185
Once-Weekly Semaglutide in Adults with Overweight or Obesity ↗
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 33567185. SHA-256 f2177628b98083064df17512c3dd229b760887c00cc64c4cfa4fc4e49523b12a.
Scientific summary uses the original 2026-08-18 source snapshot: SHA-256 b3cf6a18c3906c27475c4a49d31f5741bf40fa056afc62f07d07fa54dbff28c4.