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Study · Non-randomized trial · n = 5 · 2021

6 results

A Melanocortin-4 Receptor Agonist Induces Skin and Hair Pigmentation in Patients with Monogenic Mutations in the Leptin-Melanocortin Pathway.

Kanti V, Puder L, Jahnke I, Krabusch PM, Kottner J, Vogt A, Richter C, Andruck A, Lechner L, Poitou C, Krude H, Gottesdiener K and 5 more

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Clément K, Farooqi IS, Wiegand S, Kühnen P, Blume-Peytavi U

Skin pharmacology and physiology31 May 2021Cited by 27 (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 study6

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

  1. 01HumanNon-randomized trialSafety outcome

    In patients with POMC or LEPR deficiency, setmelanotide increased skin pigmentation in all treated patients, confirmed by spectrophotometry.

    In plain wordsIn patients with POMC or LEPR deficiency, skin pigmentation increased from before setmelanotide treatment.

    Outcome
    IncreaseSkin pigmentation
    Study

    n = 5

    Comparator
    Before treatment
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Skin pigmentation increased in all treated patients, as confirmed by spectrophotometry.
    2 context sentences
    Summary · context
    In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide.
    Summary · context
    We report the results of a maximum treatment duration of 46 months.
  2. 02HumanNon-randomized trialSafety outcome

    No malignant skin changes occurred in patients with POMC or LEPR deficiency during the setmelanotide study.

    In plain wordsNo malignant skin changes occurred in patients with POMC or LEPR deficiency during the setmelanotide study.

    Outcome
    Not applicableMalignant skin changes
    Study

    n = 5

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No malignant skin changes were observed in the patients of this study.
    2 context sentences
    Summary · context
    In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide.
    Summary · context
    We report the results of a maximum treatment duration of 46 months.
  3. 03HumanNon-randomized trialSafety outcome

    In patients with POMC or LEPR deficiency, elevated tanning intensity during continuous setmelanotide treatment may stabilize over time.

    In plain wordsIn patients with POMC or LEPR deficiency, increased tanning during setmelanotide treatment may stabilize over time.

    Outcome
    Not applicableTanning intensity over time
    Study

    n: not reported in source

    Comparator
    Before treatment
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    During continuous treatment, the current results indicate that elevated tanning intensity levels may stabilize over time.
    2 context sentences
    Summary · context
    In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide.
    Summary · context
    We report the results of a maximum treatment duration of 46 months.
  4. 04HumanNon-randomized trialSafety outcome

    In patients with POMC or LEPR deficiency, lips darkened during setmelanotide treatment.

    In plain wordsIn patients with POMC or LEPR deficiency, lips darkened from before setmelanotide treatment.

    Outcome
    IncreaseLip pigmentation
    Study

    n: not reported in source

    Comparator
    Before treatment
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lips and nevi also darkened.
    2 context sentences
    Summary · context
    In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide.
    Summary · context
    We report the results of a maximum treatment duration of 46 months.
  5. 05HumanNon-randomized trialSafety outcome

    In patients with POMC or LEPR deficiency, nevi darkened during setmelanotide treatment.

    In plain wordsIn patients with POMC or LEPR deficiency, moles darkened from before setmelanotide treatment.

    Outcome
    IncreaseNevus pigmentation
    Study

    n: not reported in source

    Comparator
    Before treatment
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lips and nevi also darkened.
    2 context sentences
    Summary · context
    In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide.
    Summary · context
    We report the results of a maximum treatment duration of 46 months.
  6. 06HumanNon-randomized trialSafety outcome

    In red-haired participants with POMC or LEPR deficiency, hair changed to brown after setmelanotide initiation.

    In plain wordsIn red-haired participants with POMC or LEPR deficiency, hair changed from red to brown after setmelanotide started.

    Outcome
    Not applicableHair color
    Study

    n: not reported in source

    Comparator
    Before treatment
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In red-haired study participants, hair color changed to brown after initiation of setmelanotide treatment.
    2 context sentences
    Summary · context
    In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide.
    Summary · context
    We report the results of a maximum treatment duration of 46 months.

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.

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