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Study · Randomized controlled trial · n = 1,206 · 2025

16 results

Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial.

Wharton S, Freitas P, Hjelmesæth J, Kabisch M, Kandler K, Lingvay I, Quiroga M, Rosenstock J, Garvey WT

The lancet. Diabetes & endocrinology14 Sept 2025Cited by 39 (Europe PMC)

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 study16

16 results from studies that gave the peptide. 16 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, semaglutide 7.2 mg reduced bodyweight by 18.7% versus 3.9% with placebo at week 72.

    In plain wordsIn adults with obesity, semaglutide 7.2 mg led to much more weight loss than placebo over 72 weeks.

    Outcome
    DecreasePercentage change in bodyweight at week 72, 7.2 mg vs placebo
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Mean bodyweight change
    −18.7%
    semaglutide 7.2 mg
    Mean bodyweight change
    −3.9%
    placebo
    Estimated treatment difference
    −14.8%
    7.2 mg vs placebo

    Source sentences

    Summary
    and with semaglutide 7·2 mg versus placebo (-18·7% [0·4] vs -3·9% [0·6]; -14·8% [-16·2 to -13·4]; p<0·0001).
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 5% or greater with semaglutide 7.2 mg than with placebo.

    In plain wordsIn adults with obesity, more people lost at least 5% of body weight with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseBodyweight reduction of 5% or greater
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    12.1 OR
    5% or greater, vs placebo

    Source sentences

    Summary
    Participants in the semaglutide 7·2 mg group were more likely than those in the placebo group to reach bodyweight reductions of 5% or greater (odds ratio 12·1 [95% CI 8·3 to 17·6]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, semaglutide 7.2 mg reduced bodyweight more than semaglutide 2.4 mg (18.7% versus 15.6%).

    In plain wordsIn adults with obesity, semaglutide 7.2 mg led to more weight loss than semaglutide 2.4 mg over 72 weeks.

    Outcome
    DecreasePercentage change in bodyweight at week 72, 7.2 mg vs 2.4 mg
    Study

    n = 1,206

    Comparator
    Semaglutide 2.4 mg
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Mean bodyweight change
    −18.7%
    semaglutide 7.2 mg
    Mean bodyweight change
    −15.6%
    semaglutide 2.4 mg
    Estimated treatment difference
    −3.1%
    7.2 mg vs 2.4 mg

    Source sentences

    Summary
    The mean change in bodyweight was greater with semaglutide 7·2 mg versus 2·4 mg (-18·7% [SE 0·4] vs -15·6% [0·7]; estimated treatment difference [ETD] -3·1% [95% CI -4·7 to -1·6]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 10% or greater with semaglutide 7.2 mg than with placebo.

    In plain wordsIn adults with obesity, more people lost at least 10% of body weight with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseBodyweight reduction of 10% or greater
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    14.5 OR
    10% or greater, vs placebo

    Source sentences

    Summary
    10% or greater (14·5 [9·6 to 21·9]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 15% or greater with semaglutide 7.2 mg than with placebo.

    In plain wordsIn adults with obesity, more people lost at least 15% of body weight with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseBodyweight reduction of 15% or greater
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    20.3 OR
    15% or greater, vs placebo

    Source sentences

    Summary
    15% or greater (20·3 [11·2 to 36·8]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 20% or greater with semaglutide 7.2 mg than with placebo.

    In plain wordsIn adults with obesity, more people lost at least 20% of body weight with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseBodyweight reduction of 20% or greater, vs placebo
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    27.3 OR
    20% or greater, vs placebo

    Source sentences

    Summary
    20% or greater (27·3 [10·9 to 68·0]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 25% or greater with semaglutide 7.2 mg than with placebo.

    In plain wordsIn adults with obesity, more people lost at least 25% of body weight with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseBodyweight reduction of 25% or greater, vs placebo
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    127.4 OR
    25% or greater, vs placebo

    Source sentences

    Summary
    25% or greater (127·4 [36·8 to 441·4]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 20% or greater with semaglutide 7.2 mg than with 2.4 mg.

    In plain wordsIn adults with obesity, more people lost at least 20% of body weight with semaglutide 7.2 mg than with 2.4 mg.

    Outcome
    IncreaseBodyweight reduction of 20% or greater, vs 2.4 mg
    Study

    n = 1,206

    Comparator
    Semaglutide 2.4 mg
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    1.8 OR
    20% or greater, 7.2 mg vs 2.4 mg

    Source sentences

    Summary
    and more likely than those in the 2·4 mg group to reach bodyweight reductions of 20% or greater (1·8 [1·3 to 2·4]; p=0·0006)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, more participants reached a bodyweight reduction of 25% or greater with semaglutide 7.2 mg than with 2.4 mg.

    In plain wordsIn adults with obesity, more people lost at least 25% of body weight with semaglutide 7.2 mg than with 2.4 mg.

    Outcome
    IncreaseBodyweight reduction of 25% or greater, vs 2.4 mg
    Study

    n = 1,206

    Comparator
    Semaglutide 2.4 mg
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Odds ratio
    2.4 OR
    25% or greater, 7.2 mg vs 2.4 mg

    Source sentences

    Summary
    25% or greater (2·4 [1·6 to 3·5]; p<0·0001)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and no diabetes, semaglutide 7.2 mg improved waist circumference versus placebo (estimated treatment difference -11.7 cm).

    In plain wordsIn adults with obesity, semaglutide 7.2 mg reduced waist size more than placebo did.

    Outcome
    DecreaseWaist circumference change
    Study

    n = 1,206

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    −11.7 cm
    7.2 mg vs placebo

    Source sentences

    Summary
    Improvements in waist circumference were observed with semaglutide 7·2 mg versus placebo (ETD -11·7 cm [95% CI -13·0 to -10·4]; p<0·0001).
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  11. 11HumanRandomized controlled trialSafety outcome

    Gastrointestinal adverse events were more common with semaglutide 7.2 mg than with 2.4 mg (70.8% versus 61.2%).

    In plain wordsStomach and gut side effects were more common with semaglutide 7.2 mg than with 2.4 mg.

    Outcome
    IncreaseGastrointestinal adverse events, 7.2 mg vs 2.4 mg
    Study

    n = 1,205

    Comparator
    Semaglutide 2.4 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with GI adverse events
    70.8%
    7.2 mg
    Participants with GI adverse events
    61.2%
    2.4 mg

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with semaglutide 7·2 mg (711 [70·8%] of 1004) versus 2·4 mg (123 [61·2%] of 201)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  12. 12HumanRandomized controlled trialSafety outcome

    Gastrointestinal adverse events were more common with semaglutide 7.2 mg than with placebo (70.8% versus 42.8%).

    In plain wordsStomach and gut side effects were more common with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseGastrointestinal adverse events, 7.2 mg vs placebo
    Study

    n = 1,205

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with GI adverse events
    70.8%
    7.2 mg
    Participants with GI adverse events
    42.8%
    placebo

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with semaglutide 7·2 mg (711 [70·8%] of 1004) versus 2·4 mg (123 [61·2%] of 201) or placebo (86 [42·8%] of 201)
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  13. 13HumanRandomized controlled trialSafety outcome

    Dysaesthesia was more common with semaglutide 7.2 mg than with 2.4 mg (22.9% versus 6.0%).

    In plain wordsSkin and nerve sensation changes (dysaesthesia) were more common with semaglutide 7.2 mg than with 2.4 mg.

    Outcome
    IncreaseDysaesthesia, 7.2 mg vs 2.4 mg
    Study

    n = 1,205

    Comparator
    Semaglutide 2.4 mg
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with dysaesthesia
    22.9%
    7.2 mg
    Participants with dysaesthesia
    6%
    2.4 mg

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with semaglutide 7·2 mg (711 [70·8%] of 1004) versus 2·4 mg (123 [61·2%] of 201) or placebo (86 [42·8%] of 201), as was dysaesthesia (230 [22·9%], 12 [6·0%], and one [0·5%], respectively).
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  14. 14HumanRandomized controlled trialSafety outcome

    Dysaesthesia was more common with semaglutide 7.2 mg than with placebo (22.9% versus 0.5%).

    In plain wordsSkin and nerve sensation changes (dysaesthesia) were more common with semaglutide 7.2 mg than with placebo.

    Outcome
    IncreaseDysaesthesia, 7.2 mg vs placebo
    Study

    n = 1,205

    Comparator
    Placebo
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with dysaesthesia
    22.9%
    7.2 mg
    Participants with dysaesthesia
    0.5%
    placebo

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with semaglutide 7·2 mg (711 [70·8%] of 1004) versus 2·4 mg (123 [61·2%] of 201) or placebo (86 [42·8%] of 201), as was dysaesthesia (230 [22·9%], 12 [6·0%], and one [0·5%], respectively).
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  15. 15HumanRandomized controlled trialSafety outcome

    Serious adverse events were reported by 6.8% of participants with semaglutide 7.2 mg and 5.5% with placebo.

    In plain wordsSerious side effects were reported by 6.8% of people on semaglutide 7.2 mg and 5.5% on placebo.

    Outcome
    Direction not reportedSerious adverse events, 7.2 mg
    Study

    n = 1,205

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    7.2 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with serious adverse events
    6.8%
    7.2 mg
    Participants with serious adverse events
    5.5%
    placebo

    Source sentences

    Summary
    Serious adverse events were reported by 68 (6·8%) of 1004 participants with semaglutide 7·2 mg, 22 (10·9%) of 201 with semaglutide 2·4 mg, and 11 (5·5%) of 201 with placebo.
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.
  16. 16HumanRandomized controlled trialSafety outcome

    Serious adverse events were reported by 10.9% of participants with semaglutide 2.4 mg and 5.5% with placebo.

    In plain wordsSerious side effects were reported by 10.9% of people on semaglutide 2.4 mg and 5.5% on placebo.

    Outcome
    Direction not reportedSerious adverse events, 2.4 mg
    Study

    n = 402

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2.4 mg once weekly · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with serious adverse events
    10.9%
    2.4 mg
    Participants with serious adverse events
    5.5%
    placebo

    Source sentences

    Summary
    Serious adverse events were reported by 68 (6·8%) of 1004 participants with semaglutide 7·2 mg, 22 (10·9%) of 201 with semaglutide 2·4 mg, and 11 (5·5%) of 201 with placebo.
    2 context sentences
    Summary · context
    STEP UP was a phase 3b, randomised, double-blind, placebo-controlled and active-controlled trial conducted across 95 hospitals, specialist clinics, and medical centres in 11 countries in adults with BMI 30 kg/m2 or greater, without diabetes.
    Summary · context
    Participants were randomly assigned (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT05646706

A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

Novo Nordisk A/Sn = 1,4074 Jan 2023 to 26 Nov 2024

Obesity

Trial pageClinicalTrials.govUpdated 23 Apr 2026

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

    11 Oct 2026, 00:04 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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