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Study · Non-randomized trial · n = 16 · 2022

11 results

ODP605 Body Mass Index and Weight Reductions in Patients With SRC1 Genetic Variant Obesity After 1 Year of Setmelanotide

The source lists no authors.

Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9624833 (opens in a new tab)PepBankPUB-95958522
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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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In patients with SRC1 variant obesity, BMI changed by −5.7% (SD 5.6%) from baseline with setmelanotide after 6 months.

    In plain wordsIn patients with SRC1 variant obesity, BMI decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI at 6 months
    Study

    n = 16

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 6 monthsAs given in this study (human).

    Measurements

    Mean percent change in BMI
    −5.7%
    All patients, 6 months of treatment across index and LTE trials, vs index trial baseline
    SD of percent change in BMI
    5.6%
    All patients, 6 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    After 6, 9, and 12 months of treatment, mean (SD) percent change in BMI was −5.7% (5.6%; n=16), −7.8% (5.8%; n=11), and −10.1% (9.4%; n=8), respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  2. 02HumanNon-randomized trialEfficacy outcome

    In patients with SRC1 variant obesity, BMI changed by −7.8% (SD 5.8%) from baseline with setmelanotide after 9 months.

    In plain wordsIn patients with SRC1 variant obesity, BMI decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI at 9 months
    Study

    n = 11

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 9 monthsAs given in this study (human).

    Measurements

    Mean percent change in BMI
    −7.8%
    All patients, 9 months of treatment across index and LTE trials, vs index trial baseline
    SD of percent change in BMI
    5.8%
    All patients, 9 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    After 6, 9, and 12 months of treatment, mean (SD) percent change in BMI was −5.7% (5.6%; n=16), −7.8% (5.8%; n=11), and −10.1% (9.4%; n=8), respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  3. 03HumanNon-randomized trialEfficacy outcome

    In adults with SRC1 variant obesity, weight changed by −6.7% (SD 6.1%) from baseline with setmelanotide at 6 months.

    In plain wordsIn adults with SRC1 variant obesity, weight decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseAdult body weight at 6 months
    Study

    n = 11

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 6 monthsAs given in this study (human).

    Measurements

    Mean percent change in body weight
    −6.7%
    Patients >=18 years, 6 months of treatment across index and LTE trials, vs index trial baseline
    SD of percent change in body weight
    6.1%
    Patients >=18 years, 6 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    Mean (SD) percent change in body weight in patients ≥18 years old at 6, 9, and 12 months was −6.7% (6.1%; n=11), −9.9% (7.4%; n=8), and −11. 0% (8.6%; n=7), respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  4. 04HumanNon-randomized trialEfficacy outcome

    In patients with SRC1 variant obesity, BMI changed by −10.1% (SD 9.4%) from baseline with setmelanotide after 12 months.

    In plain wordsIn patients with SRC1 variant obesity, BMI decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI at 12 months
    Study

    n = 8

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Measurements

    Mean percent change in BMI
    −10.1%
    All patients, 12 months of treatment across index and LTE trials, vs index trial baseline
    SD of percent change in BMI
    9.4%
    All patients, 12 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    After 6, 9, and 12 months of treatment, mean (SD) percent change in BMI was −5.7% (5.6%; n=16), −7.8% (5.8%; n=11), and −10.1% (9.4%; n=8), respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  5. 05HumanNon-randomized trialEfficacy outcome

    In adults with SRC1 variant obesity, weight changed by −9.9% (SD 7.4%) from baseline with setmelanotide at 9 months.

    In plain wordsIn adults with SRC1 variant obesity, weight decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseAdult body weight at 9 months
    Study

    n = 8

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 9 monthsAs given in this study (human).

    Measurements

    Mean percent change in body weight
    −9.9%
    Patients >=18 years, 9 months of treatment across index and LTE trials, vs index trial baseline
    SD of percent change in body weight
    7.4%
    Patients >=18 years, 9 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    Mean (SD) percent change in body weight in patients ≥18 years old at 6, 9, and 12 months was −6.7% (6.1%; n=11), −9.9% (7.4%; n=8), and −11. 0% (8.6%; n=7), respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults with SRC1 variant obesity, body weight changed by −11.0% (SD 8.6%) from baseline with setmelanotide at 12 months.

    In plain wordsIn adults with SRC1 variant obesity, weight decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseAdult body weight at 12 months
    Study

    n = 7

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Measurements

    Mean percent change in body weight
    −11%
    Patients >=18 years, 12 months of treatment across index and LTE trials, vs index trial baseline
    SD of percent change in body weight
    8.6%
    Patients >=18 years, 12 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    Mean (SD) percent change in body weight in patients ≥18 years old at 6, 9, and 12 months was −6.7% (6.1%; n=11), −9.9% (7.4%; n=8), and −11. 0% (8.6%; n=7), respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  7. 07HumanNon-randomized trialEfficacy outcome

    In patients with SRC1 variant obesity, BMI Z score changed by −0.35 (SD 0.35) with setmelanotide after 6 months.

    In plain wordsIn patients with SRC1 variant obesity, BMI Z score decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI Z score at 6 months
    Study

    n = 7

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 6 monthsAs given in this study (human).

    Measurements

    Mean change in BMI Z score
    −0.35 BMI Z score
    Patients with BMI Z score reported, 6 months of treatment across index and LTE trials, vs index trial baseline
    SD of change in BMI Z score
    0.35 BMI Z score
    Patients with BMI Z score reported, 6 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    The mean (SD) change in BMI Z score was −0.35 (0.35; n=7), −0.42 (0.23; n=5), and −0.67 (0.57; n=3) after 6, 9, and 12 months, respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  8. 08HumanNon-randomized trialEfficacy outcome

    In patients with SRC1 variant obesity, BMI Z score changed by −0.42 (SD 0.23) with setmelanotide after 9 months.

    In plain wordsIn patients with SRC1 variant obesity, BMI Z score decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI Z score at 9 months
    Study

    n = 5

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 9 monthsAs given in this study (human).

    Measurements

    Mean change in BMI Z score
    −0.42 BMI Z score
    Patients with BMI Z score reported, 9 months of treatment across index and LTE trials, vs index trial baseline
    SD of change in BMI Z score
    0.23 BMI Z score
    Patients with BMI Z score reported, 9 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    The mean (SD) change in BMI Z score was −0.35 (0.35; n=7), −0.42 (0.23; n=5), and −0.67 (0.57; n=3) after 6, 9, and 12 months, respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  9. 09HumanNon-randomized trialEfficacy outcome

    In patients with SRC1 variant obesity, BMI Z score changed by −0.67 (SD 0.57) with setmelanotide after 12 months.

    In plain wordsIn patients with SRC1 variant obesity, BMI Z score decreased from baseline during setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    DecreaseBMI Z score at 12 months
    Study

    n = 3

    Comparator
    Index trial baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Measurements

    Mean change in BMI Z score
    −0.67 BMI Z score
    Patients with BMI Z score reported, 12 months of treatment across index and LTE trials, vs index trial baseline
    SD of change in BMI Z score
    0.57 BMI Z score
    Patients with BMI Z score reported, 12 months of treatment across index and LTE trials, vs index trial baseline

    Source sentences

    Summary
    The mean (SD) change in BMI Z score was −0.35 (0.35; n=7), −0.42 (0.23; n=5), and −0.67 (0.57; n=3) after 6, 9, and 12 months, respectively.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  10. 10HumanNon-randomized trialSafety outcome

    In patients with SRC1 variant obesity, no new safety concerns emerged during long-term setmelanotide treatment.

    In plain wordsIn patients with SRC1 variant obesity, no new safety concerns emerged during long-term setmelanotide treatment.

    Peptide
    Setmelanotide
    Outcome
    Not applicableNew safety concerns
    Study

    n: not reported in source

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

    Source sentences

    Summary
    No new safety concerns emerged during long-term treatment, and no patients discontinued because of an adverse event.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, relative to index trial baseline.
  11. 11HumanNon-randomized trialSafety outcome

    No patients with SRC1 variant obesity discontinued setmelanotide because of an adverse event.

    In plain wordsNo patients with SRC1 variant obesity stopped setmelanotide because of an adverse event.

    Peptide
    Setmelanotide
    Outcome
    Not applicableAdverse event discontinuations
    Study

    n: not reported in source

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

    Measurements

    Patients discontinued because of an adverse event
    0 patients
    Long-term extension

    Source sentences

    Summary
    No new safety concerns emerged during long-term treatment, and no patients discontinued because of an adverse event.
    2 context sentences
    Summary · context
    Patients with SRC1 variant obesity aged ≥6 years were eligible for this long-term extension (LTE) trial (NCT03651765) if they completed an index trial in which they received setmelanotide and demonstrated clinical benefit on the basis of efficacy and acceptable safety as determined by the investigator.
    Summary · context
    The current analysis reports outcomes after 1 year of setmelanotide treatment across the index and LTE trials, 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.

Publication types

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