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

This study has been completed.
Sponsor:
Information provided by:
Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00537420
First received: September 28, 2007
Last updated: September 12, 2008
Last verified: September 2008

September 28, 2007
September 12, 2008
October 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment [ Time Frame: 24 Weeks ]
Complete list of historical versions of study NCT00537420 on ClinicalTrials.gov Archive Site
To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo [ Time Frame: 24 Weeks ]
Not Provided
Not Provided
 
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: Nasal Placebo
    Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
  • Drug: Placebo Capsule
    Placebo capsules will be taken once daily with or without food.
  • 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.
  • Drug: Sibutramine
    Sibutramine will be taken once daily with or without food
    Other Name: Meridia
  • Placebo Comparator: 1
    Nasal Placebo
    Intervention: Drug: Nasal Placebo
  • Placebo Comparator: 2
    Capsule Placebo
    Intervention: Drug: Placebo Capsule
  • Experimental: 3
    Nasal PYY3-36 200 ug
    Intervention: Drug: PYY3-36
  • Experimental: 4
    Nasal PYY3-36 400 ug
    Intervention: Drug: PYY3-36
  • Experimental: 5
    Nasal PYY3-36 600 ug
    Intervention: Drug: PYY3-36
  • Active Comparator: 6
    Sibutramine 10 mg
    Intervention: Drug: Sibutramine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
551
September 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00537420
C07-002
No
Gordon Brandt, M.D. / President, Nastech Pharmaceutical Company, Inc.
Nastech Pharmaceutical Company, Inc.
Not Provided
Study Director: Gordon Brandt, M.D. Nastech Pharmaceutical Company, Inc.
Nastech Pharmaceutical Company, Inc.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP