A Phase 2 interventional study of 10XB-101 Solution for Injection, 6.0% and Placebo Solution for Injection (no active ingredient) in Subcutaneous Fat Disorder, sponsored by 10xBio, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by 10xBio, LLC · Phase 2, Interventional, and Treatment
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:
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.
10xBio, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 10XB-101 Solution for Injection, 6.0%
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.
Drug: Placebo Solution for Injection (no active ingredient)
The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
Also known as: 10xB-101, 6%
Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
Also known as: Vehicle solution
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks after final injection treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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