ObesityPhase 2NCT00449202
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
A Phase 2 study testing oleoyl-estrone (MP 101) in people with Obesity, run by Manhattan Pharmaceuticals at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- oleoyl-estrone (MP 101)
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2006to not given
- 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
- Be a male or female between the ages of 18 and 65 years, inclusive
- Female subjects must be either surgically sterile or at least 2 years postmenopausal
- Have a BMI of 27 - 38.9, inclusive
- Have a stable weight for the past 30 days per subject report
- Be otherwise healthy and have an acceptable medical history
- Have negative urinalysis test results for drugs of abuse and alcohol
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- Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions
- Exhibit stable behavior patterns with regard to smoking and exercise
- Subject who has at least one factor of the metabolic syndrome
Who cannot join
- Be pregnant or nursing
- Have taken exclusionary medication in the past 30 days
- Have any clinically significant abnormal laboratory test as determined by the investigator
- Have a clinically significant illness during the 30 days before enrollment
- Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV
- Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer
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- Have a previous diagnosis of diabetes
- Be otherwise unsuitable for the study, in the opinion of the investigator
- Have an allergy to safflower seeds or its byproducts (e.g., safflower oil)
- Have any postmenopausal bleeding within the last 6 months
- Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days
- Currently working night shifts
- Have a history of known multiple miscarriages
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Pennington Biomedical Research
Baton Rouge, Louisiana, 70808
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.
- Conditions
- Obesity
- Being tested
- oleoyl-estrone (MP 101)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oleoyl-estrone (MP 101)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability
Secondary outcomes (1)
To evaluate the preliminary efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startJun 2006
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Manhattan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449202
- Sponsor's protocol ID
- MAN-OE-OS-03
- Status last verified
- Mar 2007
- First submitted
- 16 Mar 2007
- Last updated
- 20 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects
- ClinicalTrials.gov ID
- NCT00449202
- Acronym / sponsor ID
- MAN-OE-OS-03
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Manhattan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 20 Mar 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 evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be a male or female between the ages of 18 and 65 years, inclusive
- Female subjects must be either surgically sterile or at least 2 years postmenopausal
- Have a BMI of 27 - 38.9, inclusive
- Have a stable weight for the past 30 days per subject report
- Be otherwise healthy and have an acceptable medical history
Key exclusion criteria (13 listed)
- Be pregnant or nursing
- Have taken exclusionary medication in the past 30 days
- Have any clinically significant abnormal laboratory test as determined by the investigator
- Have a clinically significant illness during the 30 days before enrollment
- Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV
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 |
|---|---|---|
| oleoyl-estrone (MP 101) | Drug | – |
Primary outcome
To evaluate the safety and tolerability
1 secondary outcome
To evaluate the preliminary efficacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oleoyl-estrone (MP 101) in people with Obesity, run by Manhattan Pharmaceuticals at 3 sites in 2 countries.
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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Switzerland. 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. 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?
Results are not available in the source record.
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 safety and tolerability. 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 20 Mar 2007.