title: Efficacy and safety of intranasal peptide YY3-36 for weight reduction in obese adults.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  The study was set within a private and institutional practice.
  
  
  METHODS
  A total of 133 obese patients (body mass index, 30-43 kg/m(2); age, 18-65 yr) participated in the study.
  
  
  METHODS
  Placebo or 200- or 600-microg PYY(3-36) was administered as an intranasal spray 20 min before breakfast, lunch, and dinner in conjunction with a hypocaloric diet and exercise.
  
  
  METHODS
  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 microg three times a day (t.i.d.) and 600 microg t.i.d., respectively. In the 600 microg 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 microg, respectively. The least squares mean difference (95% confidence interval) between placebo and 200 microg 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 microg.
  
  
  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.
authors.affiliation: Clinical Research, Metabolism, Merck Research Laboratories, 126 East Lincoln Avenue, P.O. Box 2000, RY34A-A202, Rahway, NJ 07065-0900, USA. Ira_Gantz@Merck.com
authors.forename: Ira
authors.initials: I
authors.lastname: Gantz
authors.forename: Ngozi
authors.initials: N
authors.lastname: Erondu
authors.forename: Madhuja
authors.initials: M
authors.lastname: Mallick
authors.forename: Bret
authors.initials: B
authors.lastname: Musser
authors.forename: Rajesh
authors.initials: R
authors.lastname: Krishna
authors.forename: Wesley K
authors.initials: WK
authors.lastname: Tanaka
authors.forename: Karen
authors.initials: K
authors.lastname: Snyder
authors.forename: Cathy
authors.initials: C
authors.lastname: Stevens
authors.forename: Mark A
authors.initials: MA
authors.lastname: Stroh
authors.forename: Haiyuan
authors.initials: H
authors.lastname: Zhu
authors.forename: John A
authors.initials: JA
authors.lastname: Wagner
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Macneil
authors.forename: Steven B
authors.initials: SB
authors.lastname: Heymsfield
authors.forename: John M
authors.initials: JM
authors.lastname: Amatruda
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D004038:Diet, Reducing; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D010446:Peptide Fragments; D019894:Peptide YY / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D010446:Peptide Fragments; D019894:Peptide YY; C061785:peptide YY (3-36)