OR10-1 Body Mass Index and Weight Reductions in Patients With Obesity Due to Heterozygous Variants in POMC, PCSK1, and LEPR After 1 Year of Setmelanotide

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Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9624614PepBankPUB-91100043

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Summary

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

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialEfficacy outcome
In patients with heterozygous POMC, PCSK1 or LEPR variants, BMI changed by −8.14% (SD 10.13%) after 9 months of setmelanotide.
In plain wordsIn patients with heterozygous POMC, PCSK1 or LEPR variants, BMI decreased from baseline after 9 months of setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseBMI change after 9 months
Study
n = 17
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
BMI change
−8.14%
9 months
SD
10.13%
9 months
Source sentences
Summary
Mean (SD) percent change in BMI was −6.93% (9.13%; n=16), −8.14% (10.13%; n=17), and −7.83% (9.69%; n=17) after 6, 9, and 12 months of treatment, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004302
02HumanNon-randomized trialEfficacy outcome
In patients with heterozygous POMC, PCSK1 or LEPR variants, BMI changed by −7.83% (SD 9.69%) after 12 months of setmelanotide.
In plain wordsIn patients with heterozygous POMC, PCSK1 or LEPR variants, BMI decreased from baseline after 12 months of setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseBMI change after 12 months
Study
n = 17
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Measurements
BMI change
−7.83%
12 months
SD
9.69%
12 months
Source sentences
Summary
Mean (SD) percent change in BMI was −6.93% (9.13%; n=16), −8.14% (10.13%; n=17), and −7.83% (9.69%; n=17) after 6, 9, and 12 months of treatment, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004303
03HumanNon-randomized trialEfficacy outcome
In patients with heterozygous POMC, PCSK1 or LEPR variants, BMI changed by −6.93% (SD 9.13%) after 6 months of setmelanotide.
In plain wordsIn patients with heterozygous POMC, PCSK1 or LEPR variants, BMI decreased from baseline after 6 months of setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseBMI change after 6 months
Study
n = 16
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Measurements
BMI change
−6.93%
6 months
SD
9.13%
6 months
Source sentences
Summary
Mean (SD) percent change in BMI was −6.93% (9.13%; n=16), −8.14% (10.13%; n=17), and −7.83% (9.69%; n=17) after 6, 9, and 12 months of treatment, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004301
04HumanNon-randomized trialEfficacy outcome
In adults with heterozygous POMC, PCSK1 or LEPR variants, weight changed by −10.24% (SD 7.90%) after 12 months of setmelanotide.
In plain wordsIn adults with heterozygous POMC, PCSK1 or LEPR variants, weight decreased from baseline after 12 months of setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseAdult body weight change
Study
n = 15
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Measurements
Body weight percent change from baseline
−10.24%
adults, 12 months
Body weight percent change SD
7.9%
adults, 12 months
Source sentences
Summary
Of 15 patients ≥18 years old, the mean (SD) percent change in body weight was −10.24% (7.90%; n=15) after 12 months.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004304
05HumanNon-randomized trialEfficacy outcome
In the patient under 18 with a heterozygous pathway variant, BMI Z score increased by 0.64 after 12 months of setmelanotide.
In plain wordsIn the patient under 18, BMI Z score increased by 0.64 from baseline after 12 months of setmelanotide.
Peptide
Setmelanotide
Outcome
IncreasePediatric BMI Z score change
Study
n = 1
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Measurements
BMI Z score mean change from baseline
0.64 BMI Z score units
1 patient under 18 years, 12 months
Source sentences
Summary
For the 1 patient <18 years old, mean change in BMI Z score was 0.64 after 12 months.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004305
06HumanNon-randomized trialSafety outcome
No new safety concerns emerged during the setmelanotide extension in patients with heterozygous POMC, PCSK1 or LEPR variants.
In plain wordsNo new safety concerns emerged during extended setmelanotide treatment in patients with heterozygous POMC, PCSK1 or LEPR variants.
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 the LTE and 1 patient discontinued due to an adverse event, likely unrelated to treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004306
07HumanNon-randomized trialSafety outcome
One patient stopped setmelanotide during the extension because of an adverse event considered likely unrelated to treatment.
In plain wordsOne patient stopped setmelanotide during the extension because of an adverse event considered likely unrelated to treatment.
Peptide
Setmelanotide
Outcome
Not applicableAdverse-event discontinuation
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
Patients discontinuing due to adverse event
1 patients
long-term extension
Source sentences
Summary
No new safety concerns emerged during the LTE and 1 patient discontinued due to an adverse event, likely unrelated to treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator.
Summary · context
The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline.
Report a problemFND-9110004307

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.

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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