Livoletide for Prader-Willi Syndrome (PWS): Pivotal Study
What is livoletide?
Livoletide is an investigational drug being studied by Millendo Therapeutics for the treatment of patients with Prader-Willi syndrome. Livoletide has not yet been approved for use by a regulatory authority.
How is livoletide designed to work?
Based on previous research in laboratory and animal experiments, livoletide may improve hyperphagia and other metabolic effects, such as obesity and high blood glucose, by potentially counteracting a hormone in the body called Acylated Ghrelin (AG). Acylated Ghrelin (AG) stimulates appetite and is associated with other metabolic effects.
Has livoletide been administered yet to people?
Yes. More than 150 healthy volunteers and people with obesity, Type 2 diabetes, and PWS have been given livoletide in other clinical research studies. Overall, livoletide appears to be well-tolerated. In a Phase 2a study of livoletide in 47 patients with PWS, safety events in patients treated with livoletide were similar to those in the placebo group (subjects reporting any adverse events (AEs): livoletide 60.9% vs. Placebo 58.3%). Most commonly reported AEs in both groups were related to irritation at the injection site (livoletide was administered as a once or twice daily subcutaneous injection), with no serious AEs reported and no discontinuations due to AEs.