A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects

What Was Tested

This registered phase 2 trial tested Peptide YY for fat loss, obesity & body recomposition.

The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.

It had six arms (groups): 1 (placebo comparator), 2 (placebo comparator), 3 (experimental), 4 (experimental) and 5 (experimental).

Nasal Placebo.

Capsule Placebo.

The registry classes the interventions as drug.

More on the Plan

This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients.

Who Took Part

551 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or Female patients 18 and 65 years, inclusive;. BMI 30-43 kg/m2, inclusive;. In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;. Non-smoker and no use of tobacco or nicotine products for at least 3 months;. Has normal nasal mucosa.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: previous surgical treatment for obesity;; serious medical condition; serious psychiatric illness.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Peptide YY study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Peptide YY and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Peptide YY.

Those kept unaware of assignments: participant and investigator.

It started in 2007-10 with completion listed for 2008-07.

It ran at 29 sites in United States (29).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Peptide YY in 551 people with fat loss, obesity & body recomposition.

With 551 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Peptide YY compound page, Fat loss, obesity & body recomposition research.