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news.Nastech Pharmaceutical has started a six-month, randomized, placebo-controlled dose ranging Phase II study for evaluating its nasal spray in obese patients, with weight loss as the primary endpoint. The study will enroll approximately 500 obese patients.
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The study will evaluate three different doses of PYY3-36 nasal spray compared to placebo and sibutramine (Meridia), a commercially available oral weight loss drug. Patients in the active PYY treatment arms will take PYY3-36 nasal spray or nasal spray placebo three times daily prior to a meal over the 24-week period. The study design will enable patients to undergo an initial dose optimization period to establish an optimal dose to continue over the duration of the trial.
The study will also evaluate other effects including comparing the proportion of patients who lose at least 5% or 10% of their baseline body weight as well as the effect on hemoglobin A1c (HbA1c) levels.
Steven Quay, chairman, president and CEO, said: “Nastech has developed a patient friendly, non-invasive nasal spray dosage form of a naturally occurring peptide, PYY, which in the body signals the brain that you have consumed sufficient calories and to therefore stop eating. The Phase II trial that we are initiating is designed to demonstrate the effectiveness of PYY nasal spray in promoting weight loss which, if successful in development and approval, could help treat what has become an international health epidemic affecting hundreds of millions of people worldwide.”