Submental FatPhase 2NCT05154955
A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat
A Phase 2 study testing 10XB-101 Solution for Injection in people with Submental Fat, run by 10xBio, LLC at 4 sites in United States.
Trial summary
The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Submental Fat
- What is being tested?
- 10XB-101 Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Oct 2021to 19 Mar 2024
- 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
- Subject is a male or non-pregnant female 18 to 65 years old.
- Subject has provided written informed consent.
- Subject has qualifying Submental Fat evaluation score.
- Subject has had a stable body weight for the past 6 months prior to starting study.
- Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has loose skin in the submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator.
- Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery).
- Subject has any medical condition that affects clotting and/or platelet function
- Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site 03
Encino, California, 91436
Site 04
Rolling Meadows, Illinois, 60008
Site 02
San Diego, California, 92122
Site 01
San Diego, California, 92123
About this study
Official title: A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat
The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).
- Conditions
- Submental Fat
- Being tested
- 10XB-101 Solution for Injection, 10XB-101 Vehicle Solution for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10XB-101 Solution for InjectionDrug
One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
10XB-101 Vehicle Solution for InjectionDrug
This is the placebo control
| Study group | Role | What they receive |
|---|---|---|
| 10XB-101 Solution for Injection, 2.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Solution for Injection, 3.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Solution for Injection, 4.5% | Experimental | Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Vehicle Solution for Injection | Placebo comparator | Participants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. Receives: Drug: 10XB-101 Vehicle Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Submental Fat Scale (CSFS)
Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity
Measured: 24 weeks after final injection treatment
Patient Submental Fat Scale (PSFS)
Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity
Measured: 24 weeks after final injection treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start19 Oct 2021
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- 10xBio, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154955
- Sponsor's protocol ID
- 210-9451-203
- Status last verified
- Jun 2024
- First submitted
- 1 Dec 2021
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat
- ClinicalTrials.gov ID
- NCT05154955
- Acronym / sponsor ID
- 210-9451-203
- Conditions
- Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- 10xBio, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 13 Dec 2021 (actual)
- 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.
The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10XB-101 Solution for Injection, 2.0% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
| 10XB-101 Solution for Injection, 3.0% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
| 10XB-101 Solution for Injection, 4.5% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
| 10XB-101 Vehicle Solution for Injection | Placebo comparator | Drug: 10XB-101 Vehicle Solution for InjectionParticipants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a male or non-pregnant female 18 to 65 years old.
- Subject has provided written informed consent.
- Subject has qualifying Submental Fat evaluation score.
- Subject has had a stable body weight for the past 6 months prior to starting study.
- Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Key exclusion criteria (5 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has loose skin in the submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator.
- Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery).
- Subject has any medical condition that affects clotting and/or platelet function
- Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
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 |
|---|---|---|
| 10XB-101 Solution for InjectionOne of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction. | Drug | 10XB-101 Solution for Injection, 2.0%, 10XB-101 Solution for Injection, 3.0%, 10XB-101 Solution for Injection, 4.5% |
| 10XB-101 Vehicle Solution for InjectionThis is the placebo control | Drug | 10XB-101 Vehicle Solution for Injection |
Primary outcome
Clinician Submental Fat Scale (CSFS)
Time frame: 24 weeks after final injection treatment
Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity
Patient Submental Fat Scale (PSFS)
Time frame: 24 weeks after final injection treatment
Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity
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 29 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 10XB-101 Solution for Injection in people with Submental Fat, run by 10xBio, LLC at 4 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Clinician Submental Fat Scale (CSFS) (time frame: 24 weeks after final injection treatment). 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 29 Jun 2025.