RF24 | PSUN91 Body Mass Index and Weight Reduction in Patients With SH2B1 Genetic Variant Obesity After One Year of Setmelanotide

The source lists no authors.

Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9624738PepBankPUB-97532378

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Summary

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Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialEfficacy outcome
In patients with SH2B1 genetic obesity, BMI changed by −3.4% (SD 8.1%) from baseline with setmelanotide after 6 months.
In plain wordsIn patients with SH2B1 genetic obesity, BMI decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseBMI at 6 months
Study
n = 19
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
−3.4%
All patients, 6 months of treatment across index and LTE trials, vs index trial baseline
SD of percent change in BMI
8.1%
All patients, 6 months of treatment across index and LTE trials, vs index trial baseline
Source sentences
Summary
Mean (SD) percent change in BMI was −3.4% (8.1%; n=19), −5.9% (10.0%; n=15), and −9.7% (8.0%; n=14) after 6, 9, and 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237801
02HumanNon-randomized trialEfficacy outcome
In patients with SH2B1 genetic obesity, BMI changed by −5.9% (SD 10.0%) from baseline with setmelanotide after 9 months.
In plain wordsIn patients with SH2B1 genetic obesity, BMI decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseBMI at 9 months
Study
n = 15
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
−5.9%
All patients, 9 months of treatment across index and LTE trials, vs index trial baseline
SD of percent change in BMI
10%
All patients, 9 months of treatment across index and LTE trials, vs index trial baseline
Source sentences
Summary
Mean (SD) percent change in BMI was −3.4% (8.1%; n=19), −5.9% (10.0%; n=15), and −9.7% (8.0%; n=14) after 6, 9, and 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237802
03HumanNon-randomized trialEfficacy outcome
In patients with SH2B1 genetic obesity, BMI changed by −9.7% (SD 8.0%) from baseline with setmelanotide after 12 months.
In plain wordsIn patients with SH2B1 genetic obesity, BMI decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseBMI at 12 months
Study
n = 14
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
−9.7%
All patients, 12 months of treatment across index and LTE trials, vs index trial baseline
SD of percent change in BMI
8%
All patients, 12 months of treatment across index and LTE trials, vs index trial baseline
Source sentences
Summary
Mean (SD) percent change in BMI was −3.4% (8.1%; n=19), −5.9% (10.0%; n=15), and −9.7% (8.0%; n=14) after 6, 9, and 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237803
04HumanNon-randomized trialEfficacy outcome
In adults with SH2B1 genetic obesity, weight changed by −4.4% (SD 5.0%) from baseline with setmelanotide after 6 months.
In plain wordsIn adults with SH2B1 genetic obesity, weight decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseAdult weight at 6 months
Study
n = 9
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
−4.4%
Patients >=18 years, 6 months of treatment across index and LTE trials, vs index trial baseline
SD of percent change in body weight
5%
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 aged ≥18 years was −4.4% (5.0%; n=9), −6.8% (5.0%; n=7), and −7.7% (10.0%; n=8) after 6, 9, and 12 months, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237804
05HumanNon-randomized trialEfficacy outcome
In adults with SH2B1 genetic obesity, weight changed by −7.7% (SD 10.0%) from baseline with setmelanotide after 12 months.
In plain wordsIn adults with SH2B1 genetic obesity, weight decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseAdult weight 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 body weight
−7.7%
Patients >=18 years, 12 months of treatment across index and LTE trials, vs index trial baseline
SD of percent change in body weight
10%
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 aged ≥18 years was −4.4% (5.0%; n=9), −6.8% (5.0%; n=7), and −7.7% (10.0%; n=8) after 6, 9, and 12 months, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237806
06HumanNon-randomized trialEfficacy outcome
In adults with SH2B1 genetic obesity, weight changed by −6.8% (SD 5.0%) from baseline with setmelanotide after 9 months.
In plain wordsIn adults with SH2B1 genetic obesity, weight decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseAdult weight at 9 months
Study
n = 7
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
−6.8%
Patients >=18 years, 9 months of treatment across index and LTE trials, vs index trial baseline
SD of percent change in body weight
5%
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 aged ≥18 years was −4.4% (5.0%; n=9), −6.8% (5.0%; n=7), and −7.7% (10.0%; n=8) after 6, 9, and 12 months, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237805
07HumanNon-randomized trialEfficacy outcome
In patients with SH2B1 genetic obesity, BMI Z score changed by −0.55 (SD 0.17) with setmelanotide after 12 months.
In plain wordsIn patients with SH2B1 genetic obesity, BMI Z score decreased from baseline during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseBMI Z score at 12 months
Study
n = 6
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
−0.55 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
0.17 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
Mean (SD) change in BMI Z-score was −0.55 (0.17; n=6) after 12 months.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237807
08HumanNon-randomized trialSafety outcome
No patients with SH2B1 genetic obesity discontinued setmelanotide due to adverse events during the extension.
In plain wordsNo patients with SH2B1 genetic obesity stopped setmelanotide due to adverse events during the extension.
Peptide
Setmelanotide
Outcome
Not applicableAdverse event discontinuations
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
No patients discontinued due to adverse events during the LTE .
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237808
09HumanNon-randomized trialSafety outcome
In patients with SH2B1 genetic obesity, no new safety concerns emerged during long-term setmelanotide treatment.
In plain wordsIn patients with SH2B1 genetic 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.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with SH2B1 heterozygous variants or 16p11.2 deletion encompassing SH2B1 were eligible for this long-term extension (LTE) trial (NCT03651765)
Summary · context
The current analysis reports outcomes after ∼1 year of setmelanotide treatment across the index and LTE trials relative to index trial baseline.
Report a problemFND-9753237809

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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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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