Subcutaneous Abdominal AdiposityPhase 2NCT01096979
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
A Phase 2 study testing LIPO-102 in people with Subcutaneous Abdominal Adiposity, run by Neothetics, Inc at 2 sites in United States.
Trial summary
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Abdominal Adiposity
- What is being tested?
- LIPO-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Mar 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non pregnant female
- Good general health
- Sufficient abdominal fat for injections
- Signed informed consent
- BMI greater than or equal to 18 and less than 28 kg/m2
- History of stable weight in past 3 months
Who cannot join
- Known hypersensitivity to study drugs
- Treatment with an investigational agent within 30 days of first dose
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Anaheim, California
Study site
San Diego, California
About this study
Official title: A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.
- Conditions
- Subcutaneous Abdominal Adiposity
- Being tested
- LIPO-102, Placebo
- Keywords
- Subcutaneous Adipose Tissue Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-102Drug
subcutaneous injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LIPO-102, High | Experimental | LIPO-102, High Receives: Drug: LIPO-102 |
| LIPO-102, Low | Experimental | LIPO-102, Low Receives: Drug: LIPO-102 |
| Placebo | Experimental | Pbo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
Measured: 8 weeks
Reduction in abdominal adiposity
Measured: 8 weeks
Waist circumference
Measured: 8 weeks
Secondary outcomes (5)
Photographic assessments
Abdominal volume reductions
Measured: 8 weeks
Skin-fold caliper measurements
Measured: 8 weeks
Patient and clinician Global Impression of severity survey
Measured: 8 weeks
Patient and clinician global impression of change questions
Measured: 8 weeks
Abdominal appearance questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous Abdominal AdiposityStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096979
- Sponsor's protocol ID
- LIPO-102-CL-04
- Status last verified
- Mar 2015
- First submitted
- 16 Oct 2009
- 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 Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
- ClinicalTrials.gov ID
- NCT01096979
- Acronym / sponsor ID
- LIPO-102-CL-04
- Conditions
- Subcutaneous Abdominal Adiposity
- Keywords
- Subcutaneous Adipose Tissue Reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Mar 2010 (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.
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIPO-102, High | Experimental | Drug: LIPO-102LIPO-102, High |
| LIPO-102, Low | Experimental | Drug: LIPO-102LIPO-102, Low |
| Placebo | Experimental | Drug: PlaceboPbo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non pregnant female
- Good general health
- Sufficient abdominal fat for injections
- Signed informed consent
- BMI greater than or equal to 18 and less than 28 kg/m2
Key exclusion criteria (2 listed)
- Known hypersensitivity to study drugs
- Treatment with an investigational agent within 30 days of first dose
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-102subcutaneous injection | Drug | LIPO-102, High, LIPO-102, Low |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety
Time frame: 8 weeks
Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
Reduction in abdominal adiposity
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
5 secondary outcomes
Photographic assessments
Time frame: 8 weeks
Skin-fold caliper measurements
Time frame: 8 weeks
Patient and clinician Global Impression of severity survey
Time frame: 8 weeks
Patient and clinician global impression of change questions
Time frame: 8 weeks
Abdominal appearance questionnaire
Time frame: 8 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.
The record lists no contact. Use the official record to reach the sponsor.
2 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-102 in people with Subcutaneous Abdominal Adiposity, run by Neothetics, Inc at 2 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 2 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 2 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). The study lists 3 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; AzTrials last refreshed its copy on 8 Nov 2026.