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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 28, 2007

Last Updated Date

September 12, 2008

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00537420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients

Brief Summary

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

Detailed Description

This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients. The primary objective of the study is to evaluate the effect of increasing nasal PYY3-36 dosing on weight loss post 24 weeks of treatment.

Secondary Objectives:

To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
To compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
To compare the proportion of patients who lose at least 5% and 10% of the baseline body weight post 12 and 24 weeks of therapy for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule placebo
To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule placebo
To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal PYY3 36 dose groups
To evaluate the effect of 12 and 24 weeks of treatment with nasal PYY3 36 and sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse, waist circumference and BMI
To evaluate the effect of 24 weeks of treatment with nasal PYY3 36 and sibutramine on HbA1c levels

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Obesity

Intervention ^†

Drug: Nasal Placebo
Drug: Placebo Capsule
Drug: PYY3-36
Drug: Sibutramine

Study Arms / Comparison Groups

Placebo Comparator: Nasal Placebo
Placebo Comparator: Capsule Placebo
Experimental: Nasal PYY3-36 200 ug
Experimental: Nasal PYY3-36 400 ug
Experimental: Nasal PYY3-36 600 ug
Active Comparator: Sibutramine 10 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

551

Completion Date

September 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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;
Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
Has normal nasal mucosa.

Exclusion Criteria:

Previous surgical treatment for obesity;
Serious Medical Condition
Serious Psychiatric illness
Organic causes of obesity (e.g. untreated hypothyroidism)
Type 1 or Type 2 Diabetes;
Presence of uncontrolled hypertension
On prohibited concomitant medication

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537420

Responsible Party

Gordon Brandt, M.D. / President, Nastech Pharmaceutical Company, Inc.

Secondary IDs ^††

Study Sponsor ^†

Nastech Pharmaceutical Company, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Gordon Brandt, M.D.

Nastech Pharmaceutical Company, Inc.

Information Provided By

Nastech Pharmaceutical Company, Inc.

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.