Hypothalamic obesity treatment
Amount
400-600 mg
Frequency
Once daily
Duration
14 weeks (Phase 2 trial)
Route
OralTiming
Once-daily oral tablet. Significant practical advantage over setmelanotide, which requires daily subcutaneous injections.
Duration
Ongoing (long-term use expected)
Repeatable
Yes
CMP (Comprehensive Metabolic Panel)
When: Baseline
Why: Baseline liver and kidney function
Fasting glucose and HbA1c
When: Baseline
Why: Baseline metabolic status
Cortisol and pituitary panel
When: Baseline
Why: Assess hypothalamic-pituitary function given target population
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Bivamelagon (LB54640) is an oral small molecule melanocortin-4 receptor (MC4R) agonist developed by Rhythm Pharmaceuticals, licensed from LG Chem. It represents the first oral MC4R agonist in clinical development for hypothalamic obesity, a rare and severe form of obesity caused by hypothalamic damage that has very few effective treatments.
Bivamelagon activates the melanocortin-4 receptor in the hypothalamus, a critical node in the brain's appetite and energy regulation circuitry. MC4R activation suppresses hunger and increases energy expenditure. In hypothalamic obesity, this pathway is disrupted due to structural damage; bivamelagon aims to restore MC4R signaling downstream of the damaged regions.
A Phase 2 trial evaluated bivamelagon in patients aged 12 and older with hypothalamic obesity. At 14 weeks, 600 mg daily achieved a 9.3% BMI reduction and 400 mg achieved 7.7%. Hunger scores decreased by more than 2.8 points, suggesting meaningful appetite suppression in a population that typically experiences relentless hyperphagia.
Bivamelagon is investigational and not approved by any regulatory authority. It is being developed for a rare disease indication (hypothalamic obesity), not general obesity. Data are limited to a Phase 2 trial with a 14-week duration.
Phase 2 Study of Bivamelagon in Hypothalamic Obesity, published in Conference presentation (Rhythm Pharmaceuticals) (Rhythm Pharmaceuticals investigators, 2025):
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See real-world usage patterns alongside the clinical evidence above. Community-sourced, not clinically verified.
0View community protocolsMelanotan-1 (Afamelanotide): Approved alpha-MSH analog. Covers melanocortin mechanism, Scenesse for EPP, photoprotective tanning, and safety data.
Melanotan-2: Cyclic melanocortin peptide for tanning and sexual function. Covers MC1R/MC4R activation, dosing protocols, side effects, and regulation.
PT-141 (Bremelanotide): FDA-approved for hypoactive sexual desire. Covers MC4R mechanism, Vyleesi trial data, dosing, and side effects.
Setmelanotide (IMCIVREE): FDA-approved MC4R agonist for rare genetic obesity due to POMC, PCSK1, or LEPR deficiency. First-in-class targeted therapy for monogenic obesity.
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.
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