Central Abdominal BulgingPhase 2NCT02397525
An Open-Label Study to Evaluate Retreatment With LIPO-202
A Phase 2 study testing LIPO-202 in people with Central Abdominal Bulging, run by Neothetics, Inc at 8 sites in United States.
Trial summary
Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Abdominal Bulging
- What is being tested?
- LIPO-202
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2015to Jun 2016
- 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
- Provided consent
- Healthy male or non-pregnant female subjects
- BMI < 30 kg/m2
- Stable diet and exercise routine
- Central abdominal bulging that is at least "Slight Bulge, Not Flat"
Who cannot join
- Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen
- Plan on starting a weight loss or exercise program during the study.
- Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
- Known hypersensitivity to study drugs
- Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
AboutSkin Dermatology
Englewood, Colorado, 80113
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, 70124
Bass Plastic Surgery PLLC
New York, New York, 10065
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Gwinnett Clinical Research Center, Inc
Snellville, Georgia, 30078
DermResearch Center of New York
Stony Brook, New York, 11790
About this study
Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.
- Conditions
- Central Abdominal Bulging
- Being tested
- LIPO-202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-202Drug
| Study group | Role | What they receive |
|---|---|---|
| LIPO-202 | Experimental | Not described Receives: Drug: LIPO-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: vital signs, physical exams, laboratory tests
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Abdominal BulgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Feldman, Study director, Neothetics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397525
- Sponsor's protocol ID
- LIPO-202-CL-22
- Status last verified
- Aug 2015
- First submitted
- 19 Mar 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate Retreatment With LIPO-202
- ClinicalTrials.gov ID
- NCT02397525
- Acronym / sponsor ID
- LIPO-202-CL-22
- Conditions
- Central Abdominal Bulging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 25 Mar 2015 (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.
Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIPO-202 | Experimental | Drug: LIPO-202 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provided consent
- Healthy male or non-pregnant female subjects
- BMI < 30 kg/m2
- Stable diet and exercise routine
- Central abdominal bulging that is at least "Slight Bulge, Not Flat"
Key exclusion criteria (5 listed)
- Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen
- Plan on starting a weight loss or exercise program during the study.
- Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
- Known hypersensitivity to study drugs
- Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202
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 |
|---|---|---|
| LIPO-202 | Drug | LIPO-202 |
Primary outcome
Safety: vital signs, physical exams, laboratory tests
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
Maria Feldman study director
Neothetics, Inc
8 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 LIPO-202 in people with Central Abdominal Bulging, run by Neothetics, Inc at 8 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 5 inclusion and 5 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Safety: vital signs, physical exams, laboratory tests (time frame: 12 months). 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 13 Aug 2015.