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Efficacy and Safety of Intranasal Peptide YY_3–36 for Weight Reduction in Obese Adults

Merck 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 YY_3–36 (PYY_3–36), is implicated to be a postprandial satiety factor.

Objective: The aim of this study is to assess the safety, tolerability, and efficacy of intranasal PYY_3–36 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 PYY_3–36 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 PYY_3–36 as administered at these intervention doses and preprandial timing is not efficacious in inducing weight loss in obese patients after 12 wk of treatment.

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