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

September 12, 2008 updated by: Nastech Pharmaceutical Company, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

551

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Phoenix, Arizona, United States, 85050
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • California
      • Anaheim, California, United States, 92801
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Beverly Hills, California, United States, 90211
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Carmichael, California, United States, 95608
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Orange, California, United States, 92869
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Sacramento, California, United States, 95816
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • San Diego, California, United States, 92108
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • San Diego, California, United States, 92130
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • San Francisco, California, United States, 94102
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Florida
      • Pembroke Pines, Florida, United States, 33024
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Augusta, Georgia, United States, 30909
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Indiana
      • Evansville, Indiana, United States, 47713
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Valparaiso, Indiana, United States, 46383
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • New York
      • Manlius, New York, United States, 13104
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Raleigh, North Carolina, United States, 27612
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19606
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Mt. Pleasant, South Carolina, United States, 29464
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Texas
      • Austin, Texas, United States, 78705
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • San Antonio, Texas, United States, 78229-3894
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
      • Temple, Texas, United States, 76508
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
    • Utah
      • Salt Lake City, Utah, United States, 84049
        • For additional information regarding investigative sites for this trial, contact 1-425-415-3011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Nasal Placebo
Drug: Nasal Placebo
Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
Placebo Comparator: 2
Capsule Placebo
Drug: Placebo Capsule
Placebo capsules will be taken once daily with or without food.
Experimental: 3
Nasal PYY3-36 200 ug
Drug: PYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
Drug: PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Experimental: 4
Nasal PYY3-36 400 ug
Drug: PYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
Drug: PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Experimental: 5
Nasal PYY3-36 600 ug
Drug: PYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
Drug: PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Active Comparator: 6
Sibutramine 10 mg
Drug: Sibutramine
Sibutramine will be taken once daily with or without food
Other Names:
  • Meridia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
Time Frame: 24 Weeks
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nastech Pharmaceutical Company, Inc.

Investigators

  • Study Director: Gordon Brandt, M.D., Nastech Pharmaceutical Company, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

September 28, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2008

Last Update Submitted That Met QC Criteria

September 12, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C07-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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