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Journal of Clinical Endocrinology & Metabolism , doi:10.1210/jc.2006-1806 Copyright © 2007 by The Endocrine Society Efficacy and Safety of Intranasal Peptide YY3–36 for Weight Reduction in Obese AdultsIra Gantz, Ngozi Erondu, Madhuja Mallick, Bret Musser, Rajesh Krishna, Wesley K. Tanaka, Karen Snyder, Cathy Stevens, Mark A. Stroh, Haiyuan Zhu, John A. Wagner, Douglas J. MacNeil, Steven B. Heymsfield and John M. AmatrudaMerck Research Laboratories, Rahway, New Jersey 07065 Address all correspondence and requests for reprints to: Ira Gantz, M.D., Clinical Research, Metabolism, Merck Research Laboratories, 126 East Lincoln Avenue, P.O. Box 2000, RY34A-A202, Rahway, New Jersey 07065-0900. 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: The aim of this study is to assess the safety, tolerability, and efficacy of intranasal PYY3–36 to induce weight loss in obese patients. Design: The study was designed as a randomized, 2-wk, single-blind placebo run-in followed by a 12-wk double-blind, placebo-controlled treatment period. Setting: The study was set within a private and institutional practice. Patients: A total of 133 obese patients (body mass index, 30–43 kg/m2; age, 18–65 yr) participated in the study. Intervention: Placebo or 200- or 600-µg PYY3–36 was administered as an intranasal spray 20 min before breakfast, lunch, and dinner in conjunction with a hypocaloric diet and exercise. Main Outcome Measure: Body weight was the main outcome measure. Results: The number of patients completing 12 wk on the drug was 38 of 43 (88%), 31 of 44 (70%), and 12 of 46 (26%) for placebo, 200 µg three times a day (t.i.d.) and 600 µg t.i.d., respectively. In the 600 µg t.i.d. group, 27 of 46 (59%) patients discontinued due to nausea and vomiting. Among all randomized patients who took at least one drug dose and had a postbaseline measurement, the mean body weight change from baseline was –2.8, –3.7, and –1.4 kg for placebo, 200 and 600 µg, respectively. The least squares mean difference (95% confidence interval) 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 wk of treatment. This article has been cited by other articles:
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