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Study · Randomized controlled trial · n = 3,377 · 2024

5 results

Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.

Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A

JAMA internal medicine1 Nov 2024Cited by 77 (Europe PMC)

PMID39226070 (opens in a new tab)PMCIDPMC11372653 (opens in a new tab)DOI10.1001/jamainternmed.2024.4346 (opens in a new tab)PepBankPUB-39226070
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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-ND. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity and no known major psychopathology, semaglutide 2.4 mg lowered PHQ-9 scores more than placebo at week 68 (estimated difference -0.56).

    In plain wordsIn adults with overweight or obesity, semaglutide lowered depression symptom scores slightly more than placebo; the authors did not call the change clinically meaningful.

    Peptide
    Semaglutide
    Outcome
    DecreasePHQ-9 depressive symptom score at week 68
    Study

    n = 3,377

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference in PHQ-9
    −0.56 points
    week 68

    Source sentences

    Summary
    PHQ-9 scores at week 68 were 2.0 (2.9) and 2.4 (3.3), respectively; the estimated treatment difference (95% CI) between groups was -0.56 (-0.81 to -0.32) (P < .001).
    1 context sentence
    Summary · context
    This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes.
  2. 02HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity, participants on semaglutide 2.4 mg were less likely than those on placebo to shift to a more severe PHQ-9 depression category by week 68 (odds ratio 0.63).

    In plain wordsIn adults with overweight or obesity, people on semaglutide were less likely than those on placebo to move to a more severe depression category.

    Peptide
    Semaglutide
    Outcome
    DecreaseShift to a more severe PHQ-9 depression category
    Study

    n = 3,377

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).

    Source sentences

    Summary
    Participants treated with semaglutide vs placebo were less likely to shift (from baseline to week 68) to a more severe category of PHQ-9 depression (odds ratio, 0.63; 95% CI, 0.50-0.79; P < .001).
    1 context sentence
    Summary · context
    This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity, 1% or fewer reported suicidal ideation or behavior, with no differences between semaglutide 2.4 mg and placebo.

    In plain wordsIn adults with overweight or obesity, suicidal thoughts or behavior were rare and did not differ between semaglutide and placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeSuicidal ideation or behavior (C-SSRS)
    Study

    n = 3,377

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).

    Source sentences

    Summary
    Based on the Columbia-Suicide Severity Rating Scale, 1% or fewer of participants reported suicidal ideation/behavior during treatment, with no differences between semaglutide, 2.4 mg, and placebo.
    1 context sentence
    Summary · context
    This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity, psychiatric disorder adverse events were generally balanced between semaglutide 2.4 mg and placebo.

    In plain wordsIn adults with overweight or obesity, psychiatric side effects were about the same with semaglutide as with placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changePsychiatric disorder adverse events
    Study

    n = 3,377

    Comparator
    Placebo
    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).

    Source sentences

    Summary
    Psychiatric disorder adverse events were generally balanced between groups.
    1 context sentence
    Summary · context
    This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes.
  5. 05HumanRandomized controlled trialSafety outcome

    In the 104-week STEP 5 trial, psychiatric safety results with semaglutide 2.4 mg were similar to those of the pooled STEP 1, 2 and 3 analysis.

    In plain wordsIn a longer trial of adults with overweight or obesity, mental health results with semaglutide were similar to the shorter trials.

    Peptide
    Semaglutide
    Outcome
    MixedPsychiatric safety in STEP 5
    Study

    n = 304

    Comparator
    Placebo
    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    2.4 mg once weekly · subcutaneous · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar results were observed in STEP 5.
    1 context sentence
    Summary · context
    This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes.

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

Registered trials4

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

4 trials · 4 completed · 4 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03693430

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Novo Nordisk A/Sn = 3045 Oct 2018 to 23 Mar 2021

Overweight · Obesity

Trial pageClinicalTrials.govUpdated 6 Jul 2023
CompletedPhase 3Results postedNCT03611582

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

Novo Nordisk A/Sn = 6111 Aug 2018 to 28 Apr 2020

Overweight · Obesity

Trial pageClinicalTrials.govUpdated 11 Nov 2021
CompletedPhase 3Results postedNCT03548935

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Novo Nordisk A/Sn = 1,9614 Jun 2018 to 5 Mar 2021

Metabolism and Nutrition Disorder · Overweight or Obesity

Trial pageClinicalTrials.govUpdated 19 Nov 2021
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

    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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