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

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: Nasal Placebo Drug: Placebo Capsule Drug: PYY3-36 Drug: Sibutramine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Sibutramine hydrochloride Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Nastech Pharmaceutical Company, Inc.:

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 ]

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 ]

Enrollment:	551
Study Start Date:	October 2007
Study Completion Date:	September 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.
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.
Active Comparator: 6 Sibutramine 10 mg	Drug: Sibutramine Sibutramine will be taken once daily with or without food Other Name: Meridia

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537420

Show 29 Study Locations

Sponsors and Collaborators

Nastech Pharmaceutical Company, Inc.

Investigators

Study Director:

Gordon Brandt, M.D.

Nastech Pharmaceutical Company, Inc.

More Information

No publications provided

Responsible Party:	Gordon Brandt, M.D. / President, Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00537420 History of Changes
Other Study ID Numbers:	C07-002
Study First Received:	September 28, 2007
Last Updated:	September 12, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nastech Pharmaceutical Company, Inc.:

weight loss
dieting

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013