Submental FatPhase 2NCT03005717
Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat
A Phase 2 study testing LIPO-202 in people with Submental Fat, run by Neothetics, Inc at 11 sites in United States.
Trial summary
Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Submental Fat
- What is being tested?
- LIPO-202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Dec 2016to 2 Jun 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy males or non-pregnant females;
- Capable of providing written, informed consent; and ,
- Have submental bulging that is evaluated by the Investigator as "Moderate" or "Large".
Who cannot join
- History of prior treatment to reduce submental bulging;
- History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;
- History of botulinum toxin in the neck/chin area within 6 months of screening;
- Any skin conditions (including, but not limited to: skin infections, psoriasis, eczema, keloids, tattoos or hypertrophic or tethered scars) or history of trauma in the treatment area that may affect study procedures;
- A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);
- Any known hypersensitivity to the study drug and/or any of the components;
Show all 18Show fewer
- Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202 study;
- Concurrently enrolled in another investigational drug or device study or used any experimental or investigational drug or device within 30 days of screening;
- Female subject who is pregnant or lactating;
- Any medical condition that in the opinion of the Investigator might complicate study procedures or assessments or jeopardize the subject's safety, including, but not limited to:
- any bleeding or connective tissue disorders;
- any clinically significant kidney or liver disease;
- any untreated thyroid disease;
- asthma, COPD, diabetes (Type I and II) or cardiovascular disease
- history of major surgery within 30 days prior to randomization, or planned surgery during the study period;
- Used drugs with anticoagulant activity (including aspirin) within 14 days prior to randomization, β adrenergic receptor agonists or blockers, strong CYP3A inhibitors, or nonpotassium sparing diuretics (e.g., loop or thiazide diuretics) within 28 days prior to randomization;
- Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14 days prior to randomization;
- Unlikely or unable to adhere to the study visit schedule or comply with protocol procedures.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
Clinical Testing of Beverly Hills
Beverly Hills, California, 90210
Skin Research Institute
Coral Gables, Florida, 33146
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
AboutSkin Research
Greenwood Village, Colorado, 80113
Ablon Skin Institute And Research Center
Manhattan Beach, California, 90266
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Juva Skin & Laser Center
New York, New York, 10022
Skin Specialists, PC
Omaha, Nebraska, 68144
Grekin Skin Institute
Warren, Michigan, 48088
Mercy Research
Washington, Missouri, 63090
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat
Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS]) will be recruited for this study.
Read the detailed description
Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs).
The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit.
- Conditions
- Submental Fat
- Being tested
- LIPO-202, Placebo for LIPO-202
- Keywords
- submental, Salmeterol Xinafoate, LIPO-202, bulge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-202Drug
Also called Salmeterol Xinafoate for Injection
Placebo for LIPO-202Drug
Also called Placebo
Lyophile manufactured to mimic LIPO-202 lyophile.
| Study group | Role | What they receive |
|---|---|---|
| Active High | Experimental | Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX Receives: Drug: LIPO-202 |
| Active Low | Experimental | Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX Receives: Drug: LIPO-202 |
| Placebo | Placebo comparator | Placebo for LIPO 202 (Salmeterol Xinafoate for Injection) Receives: Drug: Placebo for LIPO-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by number of subjects with adverse events.
Measured: 12 weeks (Baseline through 4 weeks post last dose)
Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.
Measured: 12 weeks (Baseline through 4 weeks post last dose)
Change from baseline in the patient reported submental bulging scale.
The self-rating scale is 5-point scale that the subject evaluates their submental fat.
Measured: 12 weeks (Baseline through 4 weeks post last dose)
Change from baseline in the clinician reported submental bulging scale
The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.
Measured: 12 weeks (Baseline through 4 weeks post last dose)
Change in submental fat thickness measured with calipers (mm).
Measured: 12 weeks (Baseline through 4 weeks post last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start22 Dec 2016
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submental FatStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Piacquadio, MD, Study chair, Consultant, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005717
- Sponsor's protocol ID
- LIPO-202-CL-31
- Status last verified
- Oct 2017
- First submitted
- 21 Dec 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat
- ClinicalTrials.gov ID
- NCT03005717
- Acronym / sponsor ID
- LIPO-202-CL-31
- Conditions
- Submental Fat
- Keywords
- submental, Salmeterol Xinafoate, LIPO-202, bulge
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 29 Dec 2016 (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.
Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS]) will be recruited for this study.
Detailed description
Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs).
The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active High | Experimental | Drug: LIPO-202Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX |
| Active Low | Experimental | Drug: LIPO-202Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX |
| Placebo | Placebo comparator | Drug: Placebo for LIPO-202Placebo for LIPO 202 (Salmeterol Xinafoate for Injection) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or non-pregnant females;
- Capable of providing written, informed consent; and ,
- Have submental bulging that is evaluated by the Investigator as "Moderate" or "Large".
Key exclusion criteria (18 listed)
- History of prior treatment to reduce submental bulging;
- History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;
- History of botulinum toxin in the neck/chin area within 6 months of screening;
- Any skin conditions (including, but not limited to: skin infections, psoriasis, eczema, keloids, tattoos or hypertrophic or tethered scars) or history of trauma in the treatment area that may affect study procedures;
- A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);
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 Xinafoate for Injection | Drug | Active High, Active Low |
| Placebo for LIPO-202Also: PlaceboLyophile manufactured to mimic LIPO-202 lyophile. | Drug | Placebo |
Primary outcome
Safety as measured by number of subjects with adverse events.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
Change from baseline in the patient reported submental bulging scale.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
The self-rating scale is 5-point scale that the subject evaluates their submental fat.
Change from baseline in the clinician reported submental bulging scale
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.
Change in submental fat thickness measured with calipers (mm).
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
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 20 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Daniel Piacquadio, MD study chair
Consultant, Therapeutics, Inc.
11 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 Submental Fat, run by Neothetics, Inc at 11 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 3 inclusion and 18 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 number of subjects with adverse events. (time frame: 12 weeks (Baseline through 4 weeks post last dose)). The study lists 5 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 20 Oct 2017.