Subcutaneous Adipose Tissue ReductionPhase 1NCT00918606
An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers
A Phase 1 study testing LIPO-102 in people with Subcutaneous Adipose Tissue Reduction, run by Neothetics, Inc at 1 site in United States.
Trial summary
An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Adipose Tissue Reduction
- What is being tested?
- LIPO-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2009
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and non pregnant female
- 18-55 years old
- Sufficient abdominal fat for injections
- Signed informed consent
Who cannot join
- Known hypersensitivity to study drugs
- Treatment with an investigational agent within 30 days before first dose
Trial locations and contacts
1 site in 1 country.
About this study
An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.
- Conditions
- Subcutaneous Adipose Tissue Reduction
- Being tested
- LIPO-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-102Drug
LIPO-102
| Study group | Role | What they receive |
|---|---|---|
| LIPO-102 | Experimental | Not described Receives: Drug: LIPO-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Laboratory tests, medical exams
Measured: 4 weeks
Secondary outcomes (1)
Pharmacokinetics
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00918606
- Sponsor's protocol ID
- LIPO-102-CL-01
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2009
- Last updated
- 24 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00918606
- Acronym / sponsor ID
- LIPO-102-CL-01
- Conditions
- Subcutaneous Adipose Tissue Reduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Jun 2009 (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.
An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIPO-102 | Experimental | Drug: LIPO-102 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and non pregnant female
- 18-55 years old
- Sufficient abdominal fat for injections
- Signed informed consent
Key exclusion criteria (2 listed)
- Known hypersensitivity to study drugs
- Treatment with an investigational agent within 30 days before 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-102LIPO-102 | Drug | LIPO-102 |
Primary outcome
Safety: Laboratory tests, medical exams
Time frame: 4 weeks
1 secondary outcome
Pharmacokinetics
Time frame: 24 hours
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 24 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIPO-102 in people with Subcutaneous Adipose Tissue Reduction, run by Neothetics, Inc at 1 site 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 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 24 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Laboratory tests, medical exams (time frame: 4 weeks). 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 24 Mar 2015.