Millendo Therapeutics is preparing to initiate a Phase 2b/3 study for livoletide (AZP-531) with clinical sites in both the US and Europe. Millendo recently acquired Alize Pharma and is continuing the development of livoletide in PWS. Livoletide is an analogue of unacylated ghrelin, that counteracts some of the effects of acylated ghrelin, commonly referred to as the hunger hormone. Livoletide was previously studied in a double-blind, randomized, placebo-controlled Phase 2 clinical trial with a total of 47 subjects with PWS, demonstrating an improvement in hyperphagia as measured by the HQ at 2 weeks. (https://www.ncbi.nlm.nih.gov/pubmed/25989955)
Study Type: not yet recruiting
Eligible Ages: 8 - 65 years
Other Criteria: BMI < 65 kg/m2
More information on Millendo and livoletide can be obtained at www.millendo.com. This trial is expected to begin soon.