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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
551

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nastech Pharmaceutical Company, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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