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Study · Non-randomized trial · n = 12 · 2024

10 results

Investigation of Setmelanotide, an MC4R Agonist, for Obesity in Individuals with Smith-Magenis Syndrome

Lazareva J, Sisley SR, Brady SM, Smith ACM, Elsea SH, Pomeroy JJ, Roth CL, Sprague JE, Wabitsch M, Garrison J, Yanovski JA

Obesity research & clinical practice1 Jul 2024

PepBankPUB-96623561
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Summary

The text of this summary is not shown here, because the article license does not allow reuse.

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

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In people with Smith-Magenis syndrome, setmelanotide changed weight by −0.28% from baseline, without statistical significance.

    In plain wordsIn people with Smith-Magenis syndrome, body weight did not change significantly from baseline with setmelanotide (-0.28%).

    Peptide
    Setmelanotide
    Outcome
    No significant changeBody weight change
    Study

    n = 12

    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Measurements

    Body weight change
    −0.28%
    end-treatment
    95% CI lower
    −2.1%
    end-treatment
    95% CI upper
    1.5%
    end-treatment
    P value
    0.66
    end-treatment

    Source sentences

    Summary
    Mean percent change in body weight at end-treatment was −0.28% [(95% CI, −2.1% to 1.5%; n=12; P=0.66].
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  2. 02HumanNon-randomized trialSafety outcome

    No adverse events caused withdrawal during setmelanotide treatment in participants with Smith-Magenis syndrome.

    In plain wordsNo participants with Smith-Magenis syndrome stopped setmelanotide because of side effects.

    Peptide
    Setmelanotide
    Outcome
    Not applicableWithdrawal due to adverse events
    Study

    n = 12

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    No AEs led to withdrawal or death.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  3. 03HumanNon-randomized trialSafety outcome

    No adverse events caused death during setmelanotide treatment in participants with Smith-Magenis syndrome.

    In plain wordsNo participants with Smith-Magenis syndrome died because of side effects during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    Not applicableDeath due to adverse events
    Study

    n = 12

    Analysis
    Secondary
    Outcome group
    Mortality · Whole body
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    No AEs led to withdrawal or death.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  4. 04HumanNon-randomized trialEfficacy outcome

    In people with Smith-Magenis syndrome, self-reported hunger decreased at the end of setmelanotide treatment (p=0.011).

    In plain wordsIn people with Smith-Magenis syndrome, reported hunger decreased from baseline after setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseSelf-reported hunger
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Appetite and food intake · Metabolic and weight
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    Self-reported hunger was reduced at end-treatment (p=0.011).
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  5. 05HumanNon-randomized trialSafety outcome

    All participants with Smith-Magenis syndrome reported adverse events during setmelanotide treatment.

    In plain wordsAll participants with Smith-Magenis syndrome reported adverse events during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    Not applicableAdverse events
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    All participants reported adverse events (AEs), most commonly injection-site reactions and skin hyperpigmentation.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  6. 06HumanNon-randomized trialSafety outcome

    Injection-site reactions were among the most common adverse events during setmelanotide treatment in Smith-Magenis syndrome.

    In plain wordsInjection-site reactions were among the most common side effects in participants with Smith-Magenis syndrome who received setmelanotide.

    Peptide
    Setmelanotide
    Outcome
    Not applicableInjection-site reactions
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    All participants reported adverse events (AEs), most commonly injection-site reactions and skin hyperpigmentation.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  7. 07HumanNon-randomized trialSafety outcome

    Skin hyperpigmentation was among the most common adverse events during setmelanotide treatment in Smith-Magenis syndrome.

    In plain wordsSkin darkening was among the most common side effects in participants with Smith-Magenis syndrome who received setmelanotide.

    Peptide
    Setmelanotide
    Outcome
    Not applicableSkin hyperpigmentation
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    All participants reported adverse events (AEs), most commonly injection-site reactions and skin hyperpigmentation.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  8. 08HumanNon-randomized trialEfficacy outcome

    In people with Smith-Magenis syndrome, total cholesterol significantly decreased during setmelanotide treatment.

    In plain wordsIn people with Smith-Magenis syndrome, total cholesterol decreased during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseTotal cholesterol
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    Participants experienced a significant decrease in total cholesterol associated with a significant decrease in HDL-cholesterol and a trend for lower LDL-cholesterol.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  9. 09HumanNon-randomized trialEfficacy outcome

    In people with Smith-Magenis syndrome, HDL cholesterol significantly decreased during setmelanotide treatment.

    In plain wordsIn people with Smith-Magenis syndrome, HDL cholesterol decreased during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseHDL cholesterol
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    Participants experienced a significant decrease in total cholesterol associated with a significant decrease in HDL-cholesterol and a trend for lower LDL-cholesterol.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.
  10. 10HumanNon-randomized trialEfficacy outcome

    In people with Smith-Magenis syndrome, LDL cholesterol showed a downward trend during setmelanotide treatment.

    In plain wordsIn people with Smith-Magenis syndrome, LDL cholesterol showed a downward trend during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseLDL cholesterol
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    titrated to a maximum of 3mg · injection · 3mo at full doseAs given in this study (human).

    Source sentences

    Summary
    Participants experienced a significant decrease in total cholesterol associated with a significant decrease in HDL-cholesterol and a trend for lower LDL-cholesterol.
    2 context sentences
    Summary · context
    People with SMS received once-daily setmelanotide injections, with the dose titrated biweekly to a maximum of 3mg over ~1 month; and a full-dose treatment duration of 3mo.
    Summary · context
    12 individuals, ages 11–39y, enrolled and 10 completed the full-dose treatment phase.

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

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