setmelanotide
setmelanotide: 6 clinical trials tracked.
setmelanotide evidence translation
What we can confirm
6 tracked trials
What it means
What to watch
Prepared research question
What is verified about setmelanotide, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 1 study sponsors
Related indications
Study sponsors
Clinical Trial Registry Records (6)
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Primary endpoint: Mean % change in BMI
A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome
Primary endpoint: Frequency and severity of adverse events (AEs)
Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway
Primary endpoint: Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Primary endpoint: Pivotal Cohort: Mean Percent Change From Baseline in Body Mass Index (BMI) After 52 Weeks on a Therapeutic Regimen
Real-World Effectiveness, Safety and Patient-reported Outcomes of Setmelanotide in Patients With Bardet-Biedl Syndrome: A Prospective Mono Centric Observational Interventional Study
Primary endpoint: Percent change in BMI z-score
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients With POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway
Primary endpoint: Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMI