MDRNA’s Phase II obesity trial fails endpoint

The data indicate that PYY did not meet the primary efficacy endpoint of a dose response of weight loss versus PYY dose, nor did PYY meet the secondary efficacy endpoint of greater weight loss than the active control, sibutramine.

The 24-week, blinded, randomized, placebo-controlled dose-ranging trial in healthy obese patients evaluated three different doses of PYY nasal spray compared to placebo and sibutramine (Meridia), with the primary endpoint being weight loss.

Patients in the nasal spray treatment arms took PYY nasal spray or saline nasal spray placebo three times daily prior to a meal over the 24-week period. The study design enabled patients to undergo an initial dose titration period to establish an optimal dose to continue over the duration of the trial.

Gordon Brandt, president of MDRNA, said: “The study demonstrates that our tight junction technology effectively delivers PYY into the body via nasal administration, but that the peptide itself is not effective as a single agent for weight loss.”