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Study · Observational study · n = 30 · 2022

8 results

ODP606 Long-term Efficacy of Setmelanotide in Patients With Bardet-Biedl Syndrome

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Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9624643 (opens in a new tab)PepBankPUB-94149495
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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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanObservational studyEfficacy outcome

    In patients with BBS, BMI decreased by 9.5% (SD 10.5%) from index trial baseline after 18 months of setmelanotide.

    In plain wordsIn patients with BBS, BMI decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI at 18 months
    Study

    n = 30

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    BMI percent change from index trial baseline
    −9.5%
    patients with BBS, 18 months
    BMI percent change SD
    10.5%
    patients with BBS, 18 months

    Source sentences

    Summary
    Across age groups, after 18 and 24 months of treatment, mean (SD) percent change in BMI was −9.5% (10.5%; n=30) and −14.3% (11.6%; n=19), respectively.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  2. 02HumanObservational studyEfficacy outcome

    In patients with BBS, BMI decreased by 14.3% (SD 11.6%) from index trial baseline after 24 months of setmelanotide.

    In plain wordsIn patients with BBS, BMI decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI at 24 months
    Study

    n = 19

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 24 monthsAs given in this study (human).

    Measurements

    BMI percent change from index trial baseline
    −14.3%
    patients with BBS, 24 months
    BMI percent change SD
    11.6%
    patients with BBS, 24 months

    Source sentences

    Summary
    Across age groups, after 18 and 24 months of treatment, mean (SD) percent change in BMI was −9.5% (10.5%; n=30) and −14.3% (11.6%; n=19), respectively.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  3. 03HumanObservational studyEfficacy outcome

    In adults with BBS, body weight changed by −8.6% (SD 10.3%) from baseline with setmelanotide after 18 months.

    In plain wordsIn adults with BBS, body weight decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseAdult body weight at 18 months
    Study

    n = 15

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Mean percent change in body weight
    −8.6%
    Adults >=18 years, 18 months of treatment, vs index trial baseline
    SD of percent change in body weight
    10.3%
    Adults >=18 years, 18 months of treatment, vs index trial baseline

    Source sentences

    Summary
    Mean (SD) percent change in body weight in those ≥18 years old after 18 and 24 months was −8.6% (10.3%; n=15) and −14.9% (10.4%; n=6), respectively.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  4. 04HumanObservational studyEfficacy outcome

    In patients with BBS aged <18 years, BMI Z score changed by −0.83 (SD 0.50) with setmelanotide after 18 months.

    In plain wordsIn children with BBS, BMI Z score decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreasePediatric BMI Z score at 18 months
    Study

    n = 13

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Mean change in BMI Z score
    −0.83 BMI Z score
    Patients <18 years, 18 months of treatment, vs index trial baseline
    SD of change in BMI Z score
    0.5 BMI Z score
    Patients <18 years, 18 months of treatment, vs index trial baseline

    Source sentences

    Summary
    The mean (SD) change in BMI Z score in patients <18 years old after 18 and 24 months was −0.83 (0.50; n=13) and −0.72 (0.54; n=12), respectively.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  5. 05HumanObservational studyEfficacy outcome

    In patients with BBS aged <18 years, BMI Z score changed by −0.72 (SD 0.54) with setmelanotide after 24 months.

    In plain wordsIn children with BBS, BMI Z score decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreasePediatric BMI Z score at 24 months
    Study

    n = 12

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 24 monthsAs given in this study (human).

    Measurements

    Mean change in BMI Z score
    −0.72 BMI Z score
    Patients <18 years, 24 months of treatment, vs index trial baseline
    SD of change in BMI Z score
    0.54 BMI Z score
    Patients <18 years, 24 months of treatment, vs index trial baseline

    Source sentences

    Summary
    The mean (SD) change in BMI Z score in patients <18 years old after 18 and 24 months was −0.83 (0.50; n=13) and −0.72 (0.54; n=12), respectively.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  6. 06HumanObservational studyEfficacy outcome

    In adults with BBS, body weight changed by −14.9% (SD 10.4%) from baseline with setmelanotide after 24 months.

    In plain wordsIn adults with BBS, body weight decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseAdult body weight at 24 months
    Study

    n = 6

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 24 monthsAs given in this study (human).

    Measurements

    Mean percent change in body weight
    −14.9%
    Adults >=18 years, 24 months of treatment, vs index trial baseline
    SD of percent change in body weight
    10.4%
    Adults >=18 years, 24 months of treatment, vs index trial baseline

    Source sentences

    Summary
    Mean (SD) percent change in body weight in those ≥18 years old after 18 and 24 months was −8.6% (10.3%; n=15) and −14.9% (10.4%; n=6), respectively.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  7. 07HumanObservational studySafety outcome

    In patients with BBS, no new safety signals were observed during long-term setmelanotide treatment.

    In plain wordsIn patients with BBS, no new safety signals were observed during long-term setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    Not applicableNew safety signals
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No new safety signals were observed during long-term setmelanotide administration.
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.
  8. 08HumanObservational studySafety outcome

    One patient with BBS discontinued setmelanotide because of hallucination, considered unlikely to be related to treatment.

    In plain wordsOne patient with BBS stopped setmelanotide because of hallucination, considered unlikely to be related to treatment.

    Peptide
    Setmelanotide
    Outcome
    Not applicableDiscontinuation due to hallucination
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Measurements

    Patients discontinued because of an adverse event
    1 patients
    Long-term extension, hallucination

    Source sentences

    Summary
    One patient discontinued because of an adverse event (hallucination; unlikely to be related to setmelanotide).
    2 context sentences
    Summary · context
    Patients with BBS aged ≥6 years were eligible for this observational long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after ∼1 year of additional setmelanotide administration during the LTE trial, relative to index trial baseline.

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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