Real-World Efficacy and Safety of Setmelanotide in Adults With Monogenic or Syndromic Obesity: A Prospective Cohort Study.

Mifsud F, Chalopin S, Guillon E, Faucher P, Muller J, Le Bihan J, Clément K, Poitou C

Obesity (Silver Spring, Md.)2 Sept 2025Cited by 3 (Europe PMC)

PMID40897637DOI10.1002/oby.70002PepBankPUB-40897637

Publisher page PubMedAsk about this study

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.

01HumanObservational studyEfficacy outcome
In the setmelanotide cohort with monogenic or syndromic obesity, weight decreased 20% from the highest pretreatment weight within the first year.
In plain wordsIn this obesity cohort, setmelanotide treatment was linked to 20% weight loss from the highest pretreatment weight within the first year.
Peptide
Setmelanotide
Outcome
DecreaseWeight reduction in first year
Study
n: not reported in source
Comparator
Highest pre-treatment weight
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated
Measurements
Weight reduction
20%
From highest pretreatment weight within the first year
Source sentences
Summary
Patients experienced a clinically significant weight reduction of 20% from their highest pre-treatment weight within the first year.
1 context sentence(design, population, supporting numbers)
Summary · context
This ongoing prospective monocentric cohort includes 17 patients with obesity due to BBS (n = 11) or biallelic variants in LEPR (n = 4) or POMC (n = 2) who either started setmelanotide in routine care between 2022 and 2024 or continued therapy after participating in the RM-493-022 clinical trial.
Report a problemFND-4089763701
02HumanObservational studyEfficacy outcome
Patients previously receiving setmelanotide in a clinical trial maintained their weight loss over time.
In plain wordsPatients who previously received setmelanotide in a trial maintained their weight loss over time.
Peptide
Setmelanotide
Outcome
Direction not reportedWeight loss maintenance
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Those previously treated in a clinical trial maintained their weight loss over time.
1 context sentence(design, population, supporting numbers)
Summary · context
This ongoing prospective monocentric cohort includes 17 patients with obesity due to BBS (n = 11) or biallelic variants in LEPR (n = 4) or POMC (n = 2) who either started setmelanotide in routine care between 2022 and 2024 or continued therapy after participating in the RM-493-022 clinical trial.
Report a problemFND-4089763702
03HumanObservational studyEfficacy outcome
In the obesity cohort, setmelanotide treatment was associated with a significant 62% reduction in hunger.
In plain wordsIn the obesity cohort, setmelanotide treatment was linked to 62% less hunger.
Peptide
Setmelanotide
Outcome
DecreaseHunger
Study
n: not reported in source
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
Dose not stated
Measurements
Hunger reduction
−62%
Cohort during setmelanotide treatment
Source sentences
Summary
Additionally, eating behavior improved, with significant reductions in hunger (-62%), food craving (-41%), and external eating evaluated by DEBQ.
1 context sentence(design, population, supporting numbers)
Summary · context
This ongoing prospective monocentric cohort includes 17 patients with obesity due to BBS (n = 11) or biallelic variants in LEPR (n = 4) or POMC (n = 2) who either started setmelanotide in routine care between 2022 and 2024 or continued therapy after participating in the RM-493-022 clinical trial.
Report a problemFND-4089763703
04HumanObservational studyEfficacy outcome
In the obesity cohort, setmelanotide treatment was associated with a significant 41% reduction in food craving.
In plain wordsIn the obesity cohort, setmelanotide treatment was linked to 41% less food craving.
Peptide
Setmelanotide
Outcome
DecreaseFood craving
Study
n: not reported in source
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
Dose not stated
Measurements
Food craving reduction
−41%
Cohort during setmelanotide treatment
Source sentences
Summary
Additionally, eating behavior improved, with significant reductions in hunger (-62%), food craving (-41%), and external eating evaluated by DEBQ.
1 context sentence(design, population, supporting numbers)
Summary · context
This ongoing prospective monocentric cohort includes 17 patients with obesity due to BBS (n = 11) or biallelic variants in LEPR (n = 4) or POMC (n = 2) who either started setmelanotide in routine care between 2022 and 2024 or continued therapy after participating in the RM-493-022 clinical trial.
Report a problemFND-4089763704
05HumanObservational studyEfficacy outcome
In the obesity cohort, setmelanotide treatment was associated with significantly reduced external eating measured by DEBQ.
In plain wordsIn the obesity cohort, setmelanotide treatment was linked to less eating in response to external cues.
Peptide
Setmelanotide
Outcome
DecreaseExternal eating
Study
n: not reported in source
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Additionally, eating behavior improved, with significant reductions in hunger (-62%), food craving (-41%), and external eating evaluated by DEBQ.
1 context sentence(design, population, supporting numbers)
Summary · context
This ongoing prospective monocentric cohort includes 17 patients with obesity due to BBS (n = 11) or biallelic variants in LEPR (n = 4) or POMC (n = 2) who either started setmelanotide in routine care between 2022 and 2024 or continued therapy after participating in the RM-493-022 clinical trial.
Report a problemFND-4089763705
06HumanObservational studySafety outcome
The setmelanotide obesity cohort showed no new safety signals relative to the phase 3 safety profile.
In plain wordsThe setmelanotide obesity cohort showed no new safety signals compared with the phase 3 safety profile.
Peptide
Setmelanotide
Outcome
Not applicableNew safety signals
Study
n: not reported in source
Comparator
Phase 3 trial safety data
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
The overall safety profile was consistent with phase 3 trials data, without any new safety signals.
1 context sentence(design, population, supporting numbers)
Summary · context
This ongoing prospective monocentric cohort includes 17 patients with obesity due to BBS (n = 11) or biallelic variants in LEPR (n = 4) or POMC (n = 2) who either started setmelanotide in routine care between 2022 and 2024 or continued therapy after participating in the RM-493-022 clinical trial.
Report a problemFND-4089763706

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

Subjects

Terms as the source lists them.

Publication types

Journal Article

MeSH terms

Keywords

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