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Submitted on August 16, 2006
Accepted on February 22, 2007
* To whom correspondence should be addressed. E-mail: Ira_Gantz{at}Merck.com.
Context. The gastrointestinal peptide hormone, peptide YY3-36 (PYY3-36), is implicated to be a postprandial satiety factor.
Objective. To assess the safety, tolerability and efficacy of intranasal PYY3-36 to induce weight loss in obese patients
Design. Randomized, 2-week, single-blind placebo run-in followed by a 12-week double-blind, placebo-controlled treatment period
Setting. Private and institutional practice
Patients. 133 obese patients, body mass index (BMI) 30-43 kg/m2, inclusive, between 18 and 65 years
Intervention. Placebo or PYY3-36 administered as a 200 or 600 µg intranasal spray 20 minutes before breakfast, lunch and dinner in conjunction with a hypocaloric diet and exercise
Main Outcome Measure. Body weight
Results. The number (percent) of patients completing 12 weeks on drug was 38/43 (88%), 31/44 (70%), and 12/46 (26%) for placebo, 200 µg t.i.d. and 600 µg t.i.d., respectively. In the 600 µg t.i.d. group, 27/46 (59%) patients discontinued due to nausea and vomiting. Among all randomized patients who took at least one drug dose and had a post-baseline measurement, the mean body weight change from baseline was -2.8, -3.7 and -1.4 kg for placebo, 200 µg and 600 µg, respectively. The least squares mean difference (95% CI) between placebo and 200 µg was -0.9 (-2.6, 0.7) kg (p=0.251). A difference of 2.11 kg was sought. No meaningful inference can be drawn from the few patients who completed the study on 600 µg.
Conclusions. Intranasal PYY3-36 as administered at these intervention doses and preprandial timing is not efficacious in inducing weight loss in obese patients after 12 weeks of treatment.
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