Key takeaways:
- As soon as-daily bivamelagon conferred vital reductions in BMI at 14 weeks.
- Individuals receiving bivamelagon had vital enhancements in starvation rating in contrast with placebo.
SAN FRANCISCO — An oral melanocortin-4 receptor agonist conferred vital BMI reductions amongst adolescents and adults with hypothalamic weight problems, in keeping with a presenter.
As Healio beforehand reported, setmelanotide (Imcivree, Rhythm Prescribed drugs), a subcutaneous melanocortin-4 receptor (MC4R) agonist, was related to vital reductions in BMI and starvation amongst youngsters and adults with hypothalamic weight problems in a part 2 trial. In new information offered at ENDO 2025, researchers discovered comparable advantages with bivamelagon (Rhythm Prescribed drugs), an oral MC4R agonist. Vidhu Thaker, MD, assistant professor in pediatrics at Columbia College, described the same BMI reductions with setmelanotide and bivamelagon as “exceptional.”
An oral MC4R agonist conferred reductions in BMI for adolescents and adults with hypothalamic weight problems that have been much like what has been noticed with subcutaneous setmelanotide.
In a part 2, double-blind, placebo-controlled trial, 28 adolescents and adults aged a minimum of 12 years with hypothalamic weight problems have been randomly assigned, 1:1:1:1, to 200 mg, 400 mg or 600 mg bivamelagon or placebo as soon as every day for 14 weeks. At 14 weeks, individuals have been invited to proceed receiving the examine drug in an open-label portion of the trial for as much as 1 yr. Of the examine individuals, 26 continued to the open-label extension.
In contrast with a 2.18% BMI improve for the placebo group, individuals receiving 200 mg bivamelagon achieved a 2.68% BMI discount (P = .018), these within the 400 mg group decreased their BMI by 7.69% (P = .0002) and individuals receiving 600 mg bivamelagon had a 9.31% BMI discount (P = .0004).
Of the individuals, 16.7% within the 200 mg group, 71.4% within the 400 mg group and 75% within the 600 mg group achieved a BMI lower of 5% or extra. A BMI discount of 10% or better was achieved by 14.3% of these receiving 400 mg bivamelagon and 37.5% of individuals receiving 600 mg of the drug.
In accordance with information from a publish hoc evaluation introduced in a press launch from Rhythm Prescribed drugs, the BMI reductions with bivamelagon have been in line with what was beforehand noticed with subcutaneous setmelanotide in a part 2 and part 3 trial. In an evaluation of individuals who have been compliant to remedy and never receiving a concomitant GLP-1, a BMI discount of 9.7% was noticed within the part 2 setmelanotide trial at 12 weeks and a lower of 10.5% was seen within the part 3 trial at 16 weeks. Adults within the bivamelagon part 2 trial who have been deemed compliant to remedy had a imply BMI discount of 8.8% with the 400 mg dose and 10.1% with the 600 mg dose.
Thaker stated investigators haven’t but studied whether or not individuals with hypothalamic weight problems would favor setmelanotide or bivamelagon.
“Some individuals simply desire injectables, some individuals desire orals,” Thaker stated. “The burden of use with setmelanotide proper now could be a bit excessive as a result of [patients] have to attract it out of a vial.”
Individuals receiving bivamelagon reported better reductions in most starvation scores from baseline to 14 weeks. In contrast with a 0.8-point discount for the placebo group, the 200 mg bivamelagon group had a 2.1-point lower in most starvation scores and the 400 mg and 600 mg teams every had a 2.8-point decline.
The most typical opposed occasions within the trial have been diarrhea and nausea, with most circumstances being delicate in nature.
“There are most likely totally different mechanisms, but it surely’s comparable [to setmelanotide],” Thaker stated of the opposed occasions.
Three individuals receiving bivamelagon and one receiving placebo had delicate localized circumstances of hyperpigmentation.
Reference:
For extra info:
Vidhu Thaker, MD, will be reached at vidhu.thaker@columbia.edu.
Sources/Disclosures
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Thaker V, et al. Summary SAT-711. Offered at: ENDO annual assembly; July 12-15, 2025; San Francisco.
Disclosures:
Thaker studies that Columbia College has acquired analysis funding from Rhythm Prescribed drugs.
