beloranib (ZGN-440) / Chong Kun Dang, Larimar Therap - LARVOL DELTA

New and emerging drug molecules against obesity (J Cardiovasc Pharmacol Ther) - PMID: 24064009; “Cetilistat, a lipase inhibitor is claimed to have superior safety profile to orlistat...have limited success in early clinical development include velneperit, tesofensine, and beloranib .Tesofensine is a triple monoamine re-uptake inhibitor, velneperit acts as a neuropeptide Y5 receptor antagonist and beloranib is a methionine amino peptidase 2 inhibitor.”

Review • Obesity

Zafgen announces initiation of phase 3 trial of beloranib in Prader-Willi syndrome (Zafgen Press Release) - P3, N=84; NCT02179151; Sponsor: Zafgen; "Zafgen...announced that the Company has initiated the first Phase 3 clinical trial, in the United States, with its lead product candidate, beloranib, in the treatment of Prader-Willi syndrome (PWS)....expect to report on initial six-month data from this study in the fourth quarter of 2015."

Anticipated P3 data • New P3 trial • Obesity

An efficacy, safety and pharmacokinetics study of beloranib (ZGN-440 for injectable suspension) in obese subjects (clinicaltrials.gov) - P2, N=156; Sponsor: Zafgen, Inc.; Recruiting -> Active, not recruiting.

Enrollment closed • Obesity

bestPWS: Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P3; N=108; Terminated; Sponsor: Zafgen, Inc.; Active, not recruiting ➔ Terminated

Trial termination • Biosimilar • Growth Hormone • Obesity

Zafgen announces new weight loss and safety data from phase 2 study of beloranib in obesity at Obesity Week 2013 (Zafgen) - P2, N=147; NCT01666691; Sponsor: Zafgen; "...demonstrated significant weight loss and improvements in cardiometabolic risk markers...after 12 weeks of treatment, subjects on 0.6 mg, 1.2 mg, or 2.4 mg of beloranib lost on average (± standard error of mean) -5.5±0.5 kg, -6.9±0.6 kg, and -10.9±1.1 kg, respectively vs. -0.4±0.4 kg for those on placebo (all p<0.0001 vs. placebo)."

P2 data • Obesity

Zafgen announces initial results from phase 2a study of beloranib in patients with Prader-Willi syndrome (Zafgen) - P2, N=17; NCT01818921; Sponsor: Zafgen; "...announced initial results from its Phase 2a study of beloranib...in patients with Prader-Willi syndrome (PWS), a severe form of genetic obesity. These results showed improvements in body weight, hunger-related behaviors, and body composition, including reductions in body fat content and preserved lean body mass following four weeks of treatment."

P2 data • Obesity