WeightPhase 2NCT01180465
A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
A Phase 2 study testing LIPO-102 and LIPO-102 Low in people with Weight, run by Neothetics, Inc at 2 sites in United States.
Trial summary
LIPO-102 is under evaluation for treatment of abdominal adiposity Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight
- What is being tested?
- LIPO-102 and LIPO-102 Low
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 50 years old inclusive
- Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
- BMI < 25kg/m sq
- Stable diet and exercise and body weight
Who cannot join
- Prior treatment of abdominal subcutaneous adipose tissue
- Females within 12 months postpardum
- Known hypersensitivity to the drugs or components
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
New York, New York
Study site
San Diego, California
About this study
Official title: A Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
LIPO-102 is under evaluation for treatment of abdominal adiposity
- Conditions
- Weight
- Being tested
- LIPO-102, LIPO-102 Low, LIPO-102, Placebo
- Keywords
- Treatment of abdominal adiposity
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-102Drug
LIPO-102 High dose
LIPO-102 LowDrug
LIPO-102 Low dose
LIPO-102, PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LIPO-102 High | Experimental | Not described Receives: Drug: LIPO-102 |
| LIPO-102, Low | Experimental | Not described Receives: Drug: LIPO-102 Low |
| LIPO-102; Placebo | Placebo comparator | Not described Receives: Drug: LIPO-102, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events
Measured: 8 weeks treatment and 1 week follow up
Change in abdominal circumference
abdominal circumference
Measured: 8 weeks
Secondary outcomes (4)
photographic assessment
abdominal circumference and volume reduction assessment
Measured: 8 weeks
Abdominal subcutaneous adiposity questionnaire
Patient reported outcome
Measured: 8 weeks
Patient and clinician photo numeric scale
patient and physician reports of change
Measured: 8 weeks
Patient global assessment of severity scale
patient reports of change in severity
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 posted12 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeightStudies 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
- 160 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
- NCT01180465
- Sponsor's protocol ID
- LIPO-102-CL-09
- Other IDs
- LIPO-102-CL-09
- Status last verified
- Mar 2015
- First submitted
- 10 Aug 2010
- 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 Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
- ClinicalTrials.gov ID
- NCT01180465
- Acronym / sponsor ID
- LIPO-102-CL-09
- Conditions
- Weight
- Keywords
- Treatment of abdominal adiposity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Aug 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.
LIPO-102 is under evaluation for treatment of 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-102 |
| LIPO-102, Low | Experimental | Drug: LIPO-102 Low |
| LIPO-102; Placebo | Placebo comparator | Drug: LIPO-102, Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 - 50 years old inclusive
- Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
- BMI < 25kg/m sq
- Stable diet and exercise and body weight
Key exclusion criteria (3 listed)
- Prior treatment of abdominal subcutaneous adipose tissue
- Females within 12 months postpardum
- Known hypersensitivity to the drugs or components
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-102LIPO-102 High dose | Drug | LIPO-102 High |
| LIPO-102 LowLIPO-102 Low dose | Drug | LIPO-102, Low |
| LIPO-102, PlaceboPlacebo | Drug | LIPO-102; Placebo |
Primary outcome
Safety
Time frame: 8 weeks treatment and 1 week follow up
physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events
Change in abdominal circumference
Time frame: 8 weeks
abdominal circumference
4 secondary outcomes
photographic assessment
Time frame: 8 weeks
Abdominal subcutaneous adiposity questionnaire
Time frame: 8 weeks
Patient and clinician photo numeric scale
Time frame: 8 weeks
Patient global assessment of severity scale
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.
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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.
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 and LIPO-102 Low in people with Weight, 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 4 inclusion and 3 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. Some participants in this study may receive a placebo. 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 and 1 week follow up). The study lists 2 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.