Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

551

participants targeted

Target at P75+ for phase_2 obesity

Timeline

Completed

Started Oct 2007

Shorter than P25 for phase_2 obesity

Geographic Reach

1 country

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

September 28, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed

Same day until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed

Last Updated

September 15, 2008

Status Verified

September 1, 2008

Enrollment Period

9 months

First QC Date

September 28, 2007

Last Update Submit

September 12, 2008

Conditions

Obesity

Keywords

weight lossdieting

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (6)

1

PLACEBO COMPARATOR

Nasal Placebo

Drug: Nasal Placebo

2

PLACEBO COMPARATOR

Capsule Placebo

Drug: Placebo Capsule

3

EXPERIMENTAL

Nasal PYY3-36 200 ug

Drug: PYY3-36

4

EXPERIMENTAL

Nasal PYY3-36 400 ug

Drug: PYY3-36

5

EXPERIMENTAL

Nasal PYY3-36 600 ug

Drug: PYY3-36

6

ACTIVE COMPARATOR

Sibutramine 10 mg

Drug: Sibutramine

Interventions

Nasal PlaceboDRUG

Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.

Placebo CapsuleDRUG

Placebo capsules will be taken once daily with or without food.

PYY3-36DRUG

Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.

SibutramineDRUG

Sibutramine will be taken once daily with or without food

Also known as: Meridia

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.