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Study · Randomized controlled trial · 2025

9 results

Safety profile of semaglutide versus placebo in the SELECT study: a randomized controlled trial.

Kushner RF, Ryan DH, Deanfield J, Kokkinos A, Cercato C, Wilding J, Burguera B, Wu CC, Craciun AE, Pall D, Hramiak I, Hjelmesæth J and 6 more

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Harder-Lauridsen NM, Weimers P, Jeppesen OK, Kallenbach K, Lincoff AM, Lingvay I

Obesity (Silver Spring, Md.)13 Feb 2025Cited by 24 (Europe PMC)

PMID39948761 (opens in a new tab)PMCIDPMC11897845 (opens in a new tab)DOI10.1002/oby.24222 (opens in a new tab)PepBankPUB-39948761
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, serious adverse events were less frequent with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with heart disease and overweight, serious side effects were less common with semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseSerious adverse events
    Study

    n: not reported in source

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

    Measurements

    SAE proportion
    33.4%
    semaglutide
    SAE proportion
    36.4%
    placebo

    Source sentences

    Summary
    The proportion of patients with SAEs was lower with semaglutide versus placebo (33.4% vs. 36.4%; p < 0.001)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  2. 02HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, serious cardiac disorders were less frequent with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with heart disease and overweight, serious heart-related side effects were less common with semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseCardiac serious adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Cardiac SAE proportion
    11.5%
    semaglutide
    Cardiac SAE proportion
    13.5%
    placebo

    Source sentences

    Summary
    primarily driven by cardiac disorders (11.5% vs. 13.5%; p < 0.001)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, adverse events led to discontinuation more often with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with heart disease and overweight, more people stopped semaglutide because of side effects than stopped placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseAdverse events leading to discontinuation
    Study

    n: not reported in source

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

    Measurements

    Discontinuation proportion
    16.6%
    semaglutide
    Discontinuation proportion
    8.2%
    placebo

    Source sentences

    Summary
    The proportion of patients with AEs leading to discontinuation was higher with semaglutide versus placebo (16.6% vs. 8.2%; p < 0.001)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, gastrointestinal disorders drove more discontinuations with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with heart disease and overweight, stomach and gut side effects made more people stop semaglutide than placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseGastrointestinal adverse events leading to discontinuation
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    GI discontinuation proportion
    10%
    semaglutide
    GI discontinuation proportion
    2%
    placebo

    Source sentences

    Summary
    a difference driven by gastrointestinal disorders (10.0% vs. 2.0%)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  5. 05HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, discontinuations due to serious adverse events were similar with semaglutide 2.4 mg and placebo.

    In plain wordsIn adults with heart disease and overweight, stopping treatment because of serious side effects was similar with semaglutide and placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeSerious adverse events leading to discontinuation
    Study

    n: not reported in source

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

    Measurements

    SAE discontinuation proportion
    3.6%
    semaglutide
    SAE discontinuation proportion
    4.1%
    placebo

    Source sentences

    Summary
    however, proportions due to SAEs leading to discontinuation were similar (3.6% vs. 4.1%)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, suicide and self-injury serious adverse events were rare and balanced between semaglutide 2.4 mg and placebo.

    In plain wordsIn adults with heart disease and overweight, serious suicide or self-injury events were rare and equal in the semaglutide and placebo groups.

    Peptide
    Semaglutide
    Outcome
    No significant changeSuicide and self-injury serious adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Suicide/self-injury SAE proportion
    0.11%
    both groups

    Source sentences

    Summary
    Suicide/self-injury SAEs were low and balanced between groups (0.11% in both groups).
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  7. 07HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, gallbladder-related disorders were more frequent with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with heart disease and overweight, gallbladder problems were slightly more common with semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseGallbladder-related disorders
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Gallbladder disorder proportion
    2.8%
    semaglutide
    Gallbladder disorder proportion
    2.3%
    placebo

    Source sentences

    Summary
    Gallbladder-related disorders were more frequent with semaglutide versus placebo (2.8% vs. 2.3%; p = 0.04)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  8. 08HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, cholelithiasis was more frequent with semaglutide 2.4 mg than with placebo.

    In plain wordsIn adults with heart disease and overweight, gallstones were slightly more common with semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseCholelithiasis
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Cholelithiasis proportion
    1.4%
    semaglutide
    Cholelithiasis proportion
    1.1%
    placebo

    Source sentences

    Summary
    mainly driven by cholelithiasis (1.4% vs. 1.1%)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.
  9. 09HumanRandomized controlled trialSafety outcome

    In adults with cardiovascular disease and overweight or obesity, cholecystitis proportions were similar with semaglutide 2.4 mg and placebo.

    In plain wordsIn adults with heart disease and overweight, gallbladder inflammation was equally common with semaglutide and placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeCholecystitis
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Cholecystitis proportion
    0.6%
    both groups

    Source sentences

    Summary
    whereas proportions of cholecystitis were similar between groups (0.6% vs. 0.6%)
    2 context sentences
    Summary · context
    The objective of this study was to assess safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse cardiovascular events, in patients with established cardiovascular disease and overweight or obesity.
    Summary · context
    Safety data focused on serious adverse events (SAEs), all adverse events (AEs) leading to permanent treatment discontinuation irrespective of seriousness, and prespecified AEs of special interest irrespective of seriousness.

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

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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