ObesityPhase 2NCT00449254
Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
A Phase 2 study testing oleoyl-estrone (MP-101) in people with Obesity, run by Manhattan Pharmaceuticals at 3 sites in United States.
Trial summary
Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- oleoyl-estrone (MP-101)
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is willing and able to provide signed informed consent.
- Subject is a male and is between 18-60 years of age.
- Subject is obese as defined as a BMI of 40 - 55.
- Subject is reasonably healthy and have a reasonably acceptable medical history
- Subject has a stable weight for the past 30 days per subject report.
- Subject who has at least one factor of the metabolic
- Subject exhibits stable behavior patterns with regard to smoking and exercise
- Subject can read, speak and write the English language and agrees to follow study procedures.
Who cannot join
- Subjects who have received any investigational medication within 3 months prior to administration of study drug
- Subjects with confirmed positive results of UDS or Alcohol
- Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
- Subjects who have taken exclusionary medication
- Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
- Subjects who have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV.
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- Subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days.
- Subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer.
- Subject is otherwise unsuitable for the study, in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Across America
Dallas, Texas, 75234
St. Luke's-Roosevelt Hospital
New York, New York, 10025
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 Oleoyl-Estrone (MP-101) in Male Obese Adults.
Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese 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 startOct 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manhattan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449254
- Sponsor's protocol ID
- MAN-OE-US-04
- Status last verified
- Jun 2007
- First submitted
- 16 Mar 2007
- Last updated
- 5 Jun 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 5 Jun 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 Oleoyl-Estrone (MP-101) in Male Obese Adults.
- ClinicalTrials.gov ID
- NCT00449254
- Acronym / sponsor ID
- MAN-OE-US-04
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Manhattan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 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.
Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is willing and able to provide signed informed consent.
- Subject is a male and is between 18-60 years of age.
- Subject is obese as defined as a BMI of 40 - 55.
- Subject is reasonably healthy and have a reasonably acceptable medical history
- Subject has a stable weight for the past 30 days per subject report.
Key exclusion criteria (9 listed)
- Subjects who have received any investigational medication within 3 months prior to administration of study drug
- Subjects with confirmed positive results of UDS or Alcohol
- Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
- Subjects who have taken exclusionary medication
- Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
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 5 Jun 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 1 country: 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 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 8 inclusion and 9 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 5 Jun 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. 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 5 Jun 2007.