Effect of setmelanotide, a melanocortin-4 receptor agonist, on obesity in Bardet-Biedl syndrome.

Haws R, Brady S, Davis E, Fletty K, Yuan G, Gordon G, Stewart M, Yanovski J

Diabetes, obesity & metabolism22 Jul 2020Cited by 104 (Europe PMC)

PMID32627316PMCIDPMC7689750DOI10.1111/dom.14133PepBankPUB-32627316

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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.

01HumanNon-randomized trialEfficacy outcome
In individuals with BBS, setmelanotide reduced body weight by 5.5% from baseline at 3 months (90% CI, -9.3% to -1.6%).
In plain wordsIn individuals with BBS, weight decreased by 5.5% from baseline at 3 months with setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseBody weight at 3 months
Study
n = 8
Comparator
Baseline
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Measurements
Mean percent change in body weight at 3 months
−5.5%
BBS, n=8, from baseline
90% CI of mean percent change in body weight at 3 months
−9.3 to −1.6%
BBS, n=8
Source sentences
Summary
Mean percent change in body weight from baseline to 3 months was -5.5% (90% CI, -9.3% to -1.6%; n = 8);
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731601
02HumanNon-randomized trialSafety outcome
All participants with BBS reported at least one treatment-emergent adverse event during setmelanotide treatment.
In plain wordsAll participants with BBS reported an adverse event during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
Not applicableTreatment-emergent adverse events
Study
n: not reported in source
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Source sentences
Summary
All participants reported at least one treatment-emergent adverse event (AE), most commonly injection-site reaction.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731604
03HumanNon-randomized trialSafety outcome
In participants with BBS receiving setmelanotide, injection-site reaction was the most common treatment-emergent adverse event.
In plain wordsIn participants with BBS receiving setmelanotide, injection-site reactions were the most common adverse events.
Peptide
Setmelanotide
Outcome
Not applicableInjection-site reactions
Study
n: not reported in source
Analysis
Secondary
Outcome group
Adverse events · Skin and wound
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Source sentences
Summary
All participants reported at least one treatment-emergent adverse event (AE), most commonly injection-site reaction.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731605
04HumanNon-randomized trialSafety outcome
No adverse events led to study withdrawal in participants with BBS receiving setmelanotide.
In plain wordsNo participants with BBS stopped the setmelanotide study because of adverse events.
Peptide
Setmelanotide
Outcome
Not applicableAdverse-event withdrawal
Study
n: not reported in source
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Source sentences
Summary
No AEs led to study withdrawal or death.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731606
05HumanNon-randomized trialSafety outcome
No adverse events led to death in participants with BBS receiving setmelanotide.
In plain wordsNo adverse events caused deaths in participants with BBS receiving setmelanotide.
Peptide
Setmelanotide
Outcome
Not applicableAdverse-event deaths
Study
n: not reported in source
Analysis
Secondary
Outcome group
Mortality · Whole body
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Source sentences
Summary
No AEs led to study withdrawal or death.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731607
06HumanNon-randomized trialEfficacy outcome
In individuals with BBS, most, morning, and average hunger scores decreased across time points during setmelanotide treatment.
In plain wordsIn individuals with BBS, most, morning, and average hunger scores decreased across time points during setmelanotide treatment.
Peptide
Setmelanotide
Outcome
DecreaseMost, morning, and average hunger scores
Study
n: not reported in source
Analysis
Secondary
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Source sentences
Summary
Most, morning, and average hunger scores were reduced across time points.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731608
07HumanNon-randomized trialEfficacy outcome
In individuals with BBS, setmelanotide reduced body weight by 11.3% from baseline at 6 months (90% CI, -15.5% to -7.0%).
In plain wordsIn individuals with BBS, weight decreased by 11.3% from baseline at 6 months with setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseBody weight at 6 months
Study
n = 8
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Measurements
Mean percent change in body weight at 6 months
−11.3%
BBS, n=8, from baseline
90% CI of mean percent change in body weight at 6 months
−15.5 to −7%
BBS, n=8
Source sentences
Summary
Mean percent change in body weight from baseline to 3 months was -5.5% (90% CI, -9.3% to -1.6%; n = 8); change from baseline was -11.3% (90% CI, -15.5% to -7.0%; n = 8) at 6 months and -16.3% (90% CI, -19.9% to -12.8%; n = 7) at 12 months.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731602
08HumanNon-randomized trialEfficacy outcome
In individuals with BBS, setmelanotide reduced body weight by 16.3% from baseline at 12 months (90% CI, -19.9% to -12.8%).
In plain wordsIn individuals with BBS, weight decreased by 16.3% from baseline at 12 months with setmelanotide.
Peptide
Setmelanotide
Outcome
DecreaseBody weight at 12 months
Study
n = 7
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
≤3 mg once daily, individually titratedAs given in this study (human).
Measurements
Mean percent change in body weight at 12 months
−16.3%
BBS, n=7, from baseline
90% CI of mean percent change in body weight at 12 months
−19.9 to −12.8%
BBS, n=7
Source sentences
Summary
Mean percent change in body weight from baseline to 3 months was -5.5% (90% CI, -9.3% to -1.6%; n = 8); change from baseline was -11.3% (90% CI, -15.5% to -7.0%; n = 8) at 6 months and -16.3% (90% CI, -19.9% to -12.8%; n = 7) at 12 months.
2 context sentences(design, population, supporting numbers)
Summary · context
Individuals aged 12 years and older with BBS received once-daily setmelanotide.
Summary · context
The dose was titrated every 2 weeks to establish the individual therapeutic dose (≤3 mg); treatment continued for an additional 10 weeks.
Report a problemFND-3262731603

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

MeSH terms

Keywords

Antiobesity Drug, Appetite Control, Obesity Therapy, Phase I-ii Study

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