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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nasal Placebo
Placebo Capsule
PYY3-36
PYY3-36
PYY3-36
Sibutramine
Sponsored by
Nastech Pharmaceutical Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, dieting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011
  • For additional information regarding investigative sites for this trial, contact 1-425-415-3011

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

5

6

Arm Description

Nasal Placebo

Capsule Placebo

Nasal PYY3-36 200 ug

Nasal PYY3-36 400 ug

Nasal PYY3-36 600 ug

Sibutramine 10 mg

Outcomes

Primary Outcome Measures

To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment

Secondary Outcome Measures

To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo

Full Information

First Posted
September 28, 2007
Last Updated
September 12, 2008
Sponsor
Nastech Pharmaceutical Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00537420
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nastech Pharmaceutical Company, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, dieting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
551 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Nasal Placebo
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Capsule Placebo
Arm Title
3
Arm Type
Experimental
Arm Description
Nasal PYY3-36 200 ug
Arm Title
4
Arm Type
Experimental
Arm Description
Nasal PYY3-36 400 ug
Arm Title
5
Arm Type
Experimental
Arm Description
Nasal PYY3-36 600 ug
Arm Title
6
Arm Type
Active Comparator
Arm Description
Sibutramine 10 mg
Intervention Type
Drug
Intervention Name(s)
Nasal Placebo
Intervention Description
Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Capsule
Intervention Description
Placebo capsules will be taken once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
PYY3-36
Intervention Description
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
PYY3-36
Intervention Description
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
PYY3-36
Intervention Description
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sibutramine
Other Intervention Name(s)
Meridia
Intervention Description
Sibutramine will be taken once daily with or without food
Primary Outcome Measure Information:
Title
To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Brandt, M.D.
Organizational Affiliation
Nastech Pharmaceutical Company, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3894
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84049
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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