Periumbilical Subcutaneous Adipose Tissue ReductionPhase 2RESETNCT01802723
Dose Ranging Study
A Phase 2 study testing Drug: salmeterol xinafoate in people with Periumbilical Subcutaneous Adipose Tissue Reduction, run by Neothetics, Inc at 22 sites in United States.
Trial summary
Dose Ranging Study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periumbilical Subcutaneous Adipose Tissue Reduction
- What is being tested?
- Drug: salmeterol xinafoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2013to Oct 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight
Who cannot join
- Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
United States, Texas
Austin, Texas
United States, Florida
Aventura, Florida
United States, California
Beverly Hills, California
United States, Illinois
Buffalo Grove, Illinois
United States, North Carolina
Chapel Hill, North Carolina
United States, Illinois
Chicago, Illinois
United States, Florida
Clearwater, Florida
United States, Texas
Dallas, Texas
United States, California
Encinitas, California
United States, Texas
Fort Worth, Texas
United States, Texas
Houston, Texas
United States, Florida
Lake Worth, Florida
United States, California
Los Angeles, California
United States, Florida
Miami, Florida
United States, Tennessee
Nashville, Tennessee
United States, New York
New York, New York
United States, Texas
Plano, Texas
United States, North Carolina
Raleigh, North Carolina
United States, California
San Diego, California
United States, California
Santa Ana, California
United States, New York
Smithtown, New York
United States, Florida
Tampa, Florida
About this study
Official title: A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area
Dose Ranging Study
- Being tested
- Drug: salmeterol xinafoate, Drug: Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: salmeterol xinafoateDrug
Also called LIPO-202, Salmeterol
Drug: PlaceboDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| LIPO-202, Low | Experimental | Drug: salmeterol xinafoate Receives: Drug: Drug: salmeterol xinafoate |
| LIPO-202, Mid | Experimental | Drug: salmeterol xinafoate Receives: Drug: Drug: salmeterol xinafoate |
| LIPO-202, High | Experimental | Drug: salmeterol xinafoate Receives: Drug: Drug: salmeterol xinafoate |
| LIPO-202, Placebo | Experimental | Drug: Placebo Receives: Drug: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Measured: 8 weeks treatment
Change in global clinician abdominal perception scale score (baseline and 9 weeks)
Measured: 9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)
Measured: 9 weeks
Change in abdominal circumference (baseline and 9 weeks)
abdominal circumference
Measured: 9 weeks
Secondary outcomes (2)
Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)
Measured: 9 weeks
Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periumbilical Subcutaneous Adipose Tissue ReductionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Murray C Maytom, MBChB, MBA, Study director, Neothetics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802723
- Sponsor's protocol ID
- LIPO-202-CL-16
- Acronym
- RESET
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area
- ClinicalTrials.gov ID
- NCT01802723
- Acronym / sponsor ID
- RESET / LIPO-202-CL-16
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Mar 2013 (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.
Dose Ranging Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LIPO-202, Low | Experimental | Drug: Drug: salmeterol xinafoateDrug: salmeterol xinafoate |
| LIPO-202, Mid | Experimental | Drug: Drug: salmeterol xinafoateDrug: salmeterol xinafoate |
| LIPO-202, High | Experimental | Drug: Drug: salmeterol xinafoateDrug: salmeterol xinafoate |
| LIPO-202, Placebo | Experimental | Drug: Drug: PlaceboDrug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight
Key exclusion criteria (1 listed)
- Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
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 |
|---|---|---|
| Drug: salmeterol xinafoateAlso: LIPO-202, Salmeterol | Drug | LIPO-202, High, LIPO-202, Low, LIPO-202, Mid |
| Drug: PlaceboAlso: Placebo | Drug | LIPO-202, Placebo |
Primary outcome
Safety
Time frame: 8 weeks treatment
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Change in global clinician abdominal perception scale score (baseline and 9 weeks)
Time frame: 9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)
Time frame: 9 weeks
Change in abdominal circumference (baseline and 9 weeks)
Time frame: 9 weeks
abdominal circumference
2 secondary outcomes
Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)
Time frame: 9 weeks
Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)
Time frame: 9 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 26 Mar 2015.
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.
Murray C Maytom, MBChB, MBA study director
Neothetics, Inc
22 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 Drug: salmeterol xinafoate in people with Periumbilical Subcutaneous Adipose Tissue Reduction, run by Neothetics, Inc at 22 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 1 inclusion and 1 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
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?
Safety (time frame: 8 weeks treatment). The study lists 4 primary outcomes in all. 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 26 Mar 2015.