Subcutaneous Fat DisorderPhase 2NCT05760248
Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity
A Phase 2 study testing 10XB-101 Solution for Injection, 6.0% in people with Subcutaneous Fat Disorder, run by 10xBio, LLC at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity. The main question it aims to answer is: •How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo? Participants will be: Be… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Subcutaneous Fat Disorder
- What is being tested?
- 10XB-101 Solution for Injection, 6.0%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2023to 22 Jan 2025
- 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
- Subject is a male or non-pregnant female 18 to 55 years old.
- Subject has provided written informed consent.
- Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks.
- 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 right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator.
- Subject has any medical condition or taking medications 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
2 sites in 1 country.
United States2 sites
Site #02
New Brighton, Minnesota, 55112
Site #01
Rolling Meadows, Illinois, 60008
About this study
Official title: A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.
The main question it aims to answer is:
•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?
Participants will be:
- Be given injections every month for 5 months over the right and left flanks.
- Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.
Read the detailed description
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.
- Conditions
- Subcutaneous Fat Disorder
- Being tested
- 10XB-101 Solution for Injection, 6.0%, Placebo Solution for Injection (no active ingredient)
- Keywords
- Right and Left Flank Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10XB-101 Solution for Injection, 6.0%Drug
Also called 10xB-101, 6%
The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
Placebo Solution for Injection (no active ingredient)Drug
Also called Vehicle solution
Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 10XB-101 Solution for Injection, 6.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments. Receives: Drug: 10XB-101 Solution for Injection, 6.0% |
| Placebo Solution for Injection | Placebo comparator | Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments. Receives: Drug: Placebo Solution for Injection (no active ingredient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric measurements
Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment.
Measured: 24 weeks after final injection treatment
Flank Skin Laxity Scale (FSLS)
Change from Baseline on each flank after final treatment. Flank Skin Laxity Scale (FSLS) is a 4 point scale, with a score of 0 for no skin folds, and a score of 3 for severe or worse skin folds.A higher score means a worse outcome.
Measured: 24 weeks after final injection treatment
Clinician Global Impression of Change (CGIC)
Change from Baseline on each flank after final treatment. Clinician Global Impression of Change (CGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
Measured: 24 weeks after final injection treatment
Patient Global Impression of Change (PGIC)
Change from Baseline on each flank after final treatment. Patient Global Impression of Change (PGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
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 posted8 Mar 2023
- Study start4 May 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous Fat DisorderStudies 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
- Model description
- Active drug 6% vs Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- 10xBio, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- John Dobak, M.D., Study chair, 10xBio, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760248
- Sponsor's protocol ID
- 210-9452-201
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2023
- 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 Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
- ClinicalTrials.gov ID
- NCT05760248
- Acronym / sponsor ID
- 210-9452-201
- Conditions
- Subcutaneous Fat Disorder
- Keywords
- Right and Left Flank Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- 10xBio, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 4 May 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 8 Mar 2023 (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 goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.
The main question it aims to answer is:
•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?
Participants will be:
- Be given injections every month for 5 months over the right and left flanks.
- Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.
Detailed description
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active drug 6% vs Placebo
| Arm | Type | Receives |
|---|---|---|
| 10XB-101 Solution for Injection, 6.0% | Experimental | Drug: 10XB-101 Solution for Injection, 6.0%Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments. |
| Placebo Solution for Injection | Placebo comparator | Drug: Placebo Solution for Injection (no active ingredient)Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is a male or non-pregnant female 18 to 55 years old.
- Subject has provided written informed consent.
- Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks.
- 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 (4 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has loose skin in the right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator.
- Subject has any medical condition or taking medications 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 Injection, 6.0%Also: 10xB-101, 6%The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks. | Drug | 10XB-101 Solution for Injection, 6.0% |
| Placebo Solution for Injection (no active ingredient)Also: Vehicle solutionPlacebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks. | Drug | Placebo Solution for Injection |
Primary outcome
Volumetric measurements
Time frame: 24 weeks after final injection treatment
Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment.
Flank Skin Laxity Scale (FSLS)
Time frame: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Flank Skin Laxity Scale (FSLS) is a 4 point scale, with a score of 0 for no skin folds, and a score of 3 for severe or worse skin folds.A higher score means a worse outcome.
Clinician Global Impression of Change (CGIC)
Time frame: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Clinician Global Impression of Change (CGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
Patient Global Impression of Change (PGIC)
Time frame: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Patient Global Impression of Change (PGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
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.
John Dobak, M.D. study chair
10xBio, LLC
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 10XB-101 Solution for Injection, 6.0% in people with Subcutaneous Fat Disorder, run by 10xBio, LLC 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 5 inclusion and 4 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 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?
Volumetric measurements (time frame: 24 weeks after final injection treatment). The study lists 4 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.