ObesityPhase 2NCT00537420
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
A Phase 2 study testing PYY3-36 and Sibutramine in people with Obesity, run by Nastech Pharmaceutical Company, Inc. at 29 sites in United States.
Trial summary
The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- PYY3-36 and Sibutramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 551 participants
- Where
- 29 sitesUnited States
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Anaheim, California, 92801
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Atlanta, Georgia, 30328
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Augusta, Georgia, 30909
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Austin, Texas, 78705
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Baton Rouge, Louisiana, 70808
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Beverly Hills, California, 90211
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Brooklyn Center, Minnesota, 55430
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Carmichael, California, 95608
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Charlotte, North Carolina, 28209
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Cleveland, Ohio, 44122
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Evansville, Indiana, 47713
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Greer, South Carolina, 29651
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Las Vegas, Nevada, 89104
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Manlius, New York, 13104
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Mt. Pleasant, South Carolina, 29464
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Orange, California, 92869
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Pembroke Pines, Florida, 33024
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Peoria, Arizona, 85381
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Phoenix, Arizona, 85050
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Raleigh, North Carolina, 27612
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Reading, Pennsylvania, 19606
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Sacramento, California, 95816
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Salt Lake City, Utah, 84049
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
San Antonio, Texas, 78229-3894
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
San Diego, California, 92108
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
San Diego, California, 92130
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
San Francisco, California, 94102
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Temple, Texas, 76508
For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Valparaiso, Indiana, 46383
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity
- Being tested
- Nasal Placebo, Placebo Capsule, PYY3-36, Sibutramine
- Keywords
- weight loss, dieting
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PYY3-36Drug
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
PYY3-36Drug
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
SibutramineDrug
Also called Meridia
Sibutramine will be taken once daily with or without food
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Nasal Placebo Receives: Drug: Nasal Placebo |
| 2 | Placebo comparator | Capsule Placebo Receives: Drug: Placebo Capsule |
| 3 | Experimental | Nasal PYY3-36 200 ug Receives: Drug: PYY3-36 |
| 4 | Experimental | Nasal PYY3-36 400 ug Receives: Drug: PYY3-36 |
| 5 | Experimental | Nasal PYY3-36 600 ug Receives: Drug: PYY3-36 |
| 6 | Active comparator | Sibutramine 10 mg Receives: Drug: Sibutramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
Measured: 24 Weeks
Secondary outcomes (1)
To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nastech Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gordon Brandt, M.D., Study director, Nastech Pharmaceutical Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537420
- Sponsor's protocol ID
- C07-002
- Status last verified
- Sep 2008
- First submitted
- 28 Sep 2007
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients
- ClinicalTrials.gov ID
- NCT00537420
- Acronym / sponsor ID
- C07-002
- Conditions
- Obesity
- Keywords
- weight loss, dieting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- Nastech Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Nasal PlaceboNasal Placebo |
| 2 | Placebo comparator | Drug: Placebo CapsuleCapsule Placebo |
| 3 | Experimental | Drug: PYY3-36Nasal PYY3-36 200 ug |
| 4 | Experimental | Drug: PYY3-36Nasal PYY3-36 400 ug |
| 5 | Experimental | Drug: PYY3-36Nasal PYY3-36 600 ug |
| 6 | Active comparator | Drug: SibutramineSibutramine 10 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal PlaceboNasal placebo, three times a day, 30 minutes before a meal for 24 weeks. | Drug | 1 |
| Placebo CapsulePlacebo capsules will be taken once daily with or without food. | Drug | 2 |
| PYY3-36Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks. | Drug | 3 |
| PYY3-36Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks. | Drug | 4 |
| PYY3-36Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks. | Drug | 5 |
| SibutramineAlso: MeridiaSibutramine will be taken once daily with or without food | Drug | 6 |
Primary outcome
To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
Time frame: 24 Weeks
1 secondary outcome
To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Brandt, M.D. study director
Nastech Pharmaceutical Company, Inc.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PYY3-36 and Sibutramine in people with Obesity, run by Nastech Pharmaceutical Company, Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2008.