Central Abdominal BulgingPhase 2NCT02568319

Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects

A Phase 2 study testing LIPO-202 in people with Central Abdominal Bulging, run by Neothetics, Inc at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Central Abdominal Bulging
What is being tested?: LIPO-202
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 6 sitesUnited States
Study dates: Sep 2015to Dec 2015
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Healthy male or non-pregnant female subjects
Capable of providing written consent
BMI > 30 kg/m2 but < 40 kg/m2
Stable diet and exercise routine
At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Who cannot join

BMI > 40 kg/m2
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
Known hypersensitivity to study drugs
Have any medical condition that might complicate study procedures

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

The Center for Clinical & Cosmetic Research
Aventura, Florida, 33180
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911
Skin Research Institute
Coral Gables, Florida, 33146
Diagnamics, Inc.
Encinitas, California, 92024
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Tennessee Clinical Research Center
Nashville, Tennessee, 37215

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging in a Defined Special Population - Obese Subjects (BMI > or Equal to 30 kg/m2)

This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.

Conditions: Central Abdominal Bulging
Being tested: LIPO-202, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIPO-202Drug
Also called Salmeterol
PlaceboDrug
Also called Placebo for LIPO-202

Study groups in NCT02568319
Study group	Role	What they receive
LIPO-202	Experimental	Experimental arm Receives: Drug: LIPO-202
Placebo	Placebo comparator	Placebo comparator Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
Physical examination, adverse events, vital signs, and laboratory tests.
Measured: 9 weeks

Secondary outcomes (1)

Change in waist circumference.
Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Dec 2015

First posted5 Oct 2015 (estimated)
Study startSep 2015
Primary completionDec 2015

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02568319
Sponsor's protocol ID: LIPO-202-CL-21
Status last verified: Oct 2015
First submitted: 2 Oct 2015
Last updated: 24 Dec 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging in a Defined Special Population - Obese Subjects (BMI > or Equal to 30 kg/m2)
ClinicalTrials.gov ID: NCT02568319
Acronym / sponsor ID: LIPO-202-CL-21
Conditions: Central Abdominal Bulging
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (estimated)
Lead sponsor: Neothetics, IncIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Dec 2015 (actual)
First posted: 5 Oct 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.

This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LIPO-202	Experimental	Drug: LIPO-202Experimental arm
Placebo	Placebo comparator	Drug: PlaceboPlacebo comparator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy male or non-pregnant female subjects
Capable of providing written consent
BMI > 30 kg/m2 but < 40 kg/m2
Stable diet and exercise routine
At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Key exclusion criteria (5 listed)

BMI > 40 kg/m2
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
Known hypersensitivity to study drugs
Have any medical condition that might complicate study procedures

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-202Also: Salmeterol	Drug	LIPO-202
PlaceboAlso: Placebo for LIPO-202	Drug	Placebo

Primary outcome

Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
Time frame: 9 weeks
Physical examination, adverse events, vital signs, and laboratory tests.

1 secondary outcome

Change in waist circumference.
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 24 Dec 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

6 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 6 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: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 as measured by physical examination, adverse events, vital signs, and laboratory tests. (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02568319.

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 Dec 2015.