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Study · Randomized controlled trial · n = 1,210 · 2021

6 results

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.

Davies M, Færch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I

Lancet (London, England)2 Mar 2021Cited by 1,104 (Europe PMC)

PMID33667417 (opens in a new tab)DOI10.1016/s0140-6736(21)00213-0 (opens in a new tab)PepBankPUB-33667417
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity and type 2 diabetes, semaglutide 2.4 mg reduced body weight more than placebo at week 68.

    In plain wordsIn adults with overweight or obesity and type 2 diabetes, semaglutide 2.4 mg led to more weight loss than placebo.

    Peptide
    Semaglutide
    Outcome
    DecreasePercentage change in bodyweight at week 68
    Study

    n = 1,210

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2·4 mg once a week · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Body weight change
    −9.6%
    semaglutide 2.4 mg
    Body weight change
    −3.4%
    placebo
    Treatment difference
    −6.2 percentage points
    semaglutide 2.4 mg vs placebo

    Source sentences

    Summary
    Estimated change in mean bodyweight from baseline to week 68 was -9·6% (SE 0·4) with semaglutide 2·4 mg vs -3·4% (0·4) with placebo. Estimated treatment difference for semaglutide 2·4 mg versus placebo was -6·2 percentage points (95% CI -7·3 to -5·2; p<0·0001).
    2 context sentences
    Summary · context
    This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening.
    Summary · context
    Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a li…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity and type 2 diabetes, more patients on semaglutide 2.4 mg than on placebo achieved a weight reduction of at least 5%.

    In plain wordsIn adults with overweight or obesity and type 2 diabetes, more people on semaglutide 2.4 mg than placebo lost at least 5% of body weight.

    Peptide
    Semaglutide
    Outcome
    IncreaseWeight reduction of at least 5% at week 68
    Study

    n = 764

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2·4 mg once a week · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Proportion with weight loss of at least 5%
    68.8%
    semaglutide 2.4 mg
    Proportion with weight loss of at least 5%
    28.5%
    placebo
    Odds ratio
    4.88 ratio
    semaglutide 2.4 mg vs placebo

    Source sentences

    Summary
    At week 68, more patients on semaglutide 2·4 mg than on placebo achieved weight reductions of at least 5% (267 [68·8%] of 388 vs 107 [28·5%] of 376; odds ratio 4·88, 95% CI 3·58 to 6·64; p<0·0001).
    2 context sentences
    Summary · context
    This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening.
    Summary · context
    Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a li…
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity and type 2 diabetes, adverse events were more frequent with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with overweight or obesity and type 2 diabetes, adverse events were more common with semaglutide 2.4 mg than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseAdverse events (any)
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2·4 mg once a week · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Patients with adverse events
    87.6%
    semaglutide 2.4 mg
    Patients with adverse events
    76.9%
    placebo

    Source sentences

    Summary
    Adverse events were more frequent with semaglutide 2·4 mg (in 353 [87·6%] of 403 patients) and 1·0 mg (329 [81·8%] of 402) than with placebo (309 [76·9%] of 402).
    2 context sentences
    Summary · context
    This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening.
    Summary · context
    Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a li…
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity and type 2 diabetes, adverse events were more frequent with semaglutide 1.0 mg than with placebo.

    In plain wordsIn adults with overweight or obesity and type 2 diabetes, adverse events were more common with semaglutide 1.0 mg than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseAdverse events (any), 1.0 mg
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1·0 mg once a week · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Patients with adverse events
    81.8%
    semaglutide 1.0 mg
    Patients with adverse events
    76.9%
    placebo

    Source sentences

    Summary
    Adverse events were more frequent with semaglutide 2·4 mg (in 353 [87·6%] of 403 patients) and 1·0 mg (329 [81·8%] of 402) than with placebo (309 [76·9%] of 402).
    2 context sentences
    Summary · context
    This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening.
    Summary · context
    Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a li…
  5. 05HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity and type 2 diabetes, gastrointestinal adverse events, mostly mild to moderate, were more frequent with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with overweight or obesity and type 2 diabetes, stomach and gut side effects were more common with semaglutide 2.4 mg than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2·4 mg once a week · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Patients with GI adverse events
    63.5%
    semaglutide 2.4 mg
    Patients with GI adverse events
    34.3%
    placebo

    Source sentences

    Summary
    Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 256 (63·5%) of 403 patients with semaglutide 2·4 mg, 231 (57·5%) of 402 with semaglutide 1·0 mg, and 138 (34·3%) of 402 with placebo.
    2 context sentences
    Summary · context
    This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening.
    Summary · context
    Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a li…
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity and type 2 diabetes, gastrointestinal adverse events, mostly mild to moderate, were more frequent with semaglutide 1.0 mg than with placebo.

    In plain wordsIn adults with overweight or obesity and type 2 diabetes, stomach and gut side effects were more common with semaglutide 1.0 mg than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseGastrointestinal adverse events, 1.0 mg
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1·0 mg once a week · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Patients with GI adverse events
    57.5%
    semaglutide 1.0 mg
    Patients with GI adverse events
    34.3%
    placebo

    Source sentences

    Summary
    Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 256 (63·5%) of 403 patients with semaglutide 2·4 mg, 231 (57·5%) of 402 with semaglutide 1·0 mg, and 138 (34·3%) of 402 with placebo.
    2 context sentences
    Summary · context
    This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening.
    Summary · context
    Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a li…

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials3

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

3 trials · 1 not yet recruiting · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 4NCT07462663

SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer

Hospital Universitari de Bellvitgen = 80est. Jan 2027 to est. Jan 2035

Endometrial Cancer · Endometrial Cancer Stage I · Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I · Atypical Endometrial Hyperplasia · Endometrial Intraepithelial Neoplasia · Obesity & Overweight · BMI>40 · Obesity · Obesity Grade III

Trial pageClinicalTrials.govUpdated 10 Jun 2026
CompletedPhase 3Results postedNCT03811574

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Novo Nordisk A/Sn = 40121 Jan 2019 to 20 Nov 2020

Overweight · Obesity

Trial pageClinicalTrials.govUpdated 22 Mar 2022
CompletedPhase 3Results postedNCT03552757

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

Novo Nordisk A/Sn = 1,2104 Jun 2018 to 1 May 2020

Obesity · Overweight

Trial pageClinicalTrials.govUpdated 9 Nov 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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