NCT05760248CompletedPhase 2
Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity
A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 27 Feb 2023
- Start date
- May 2023
- Primary completion date
- Jan 2025
- Lead sponsor
- 10xBio, LLC
- NCT number
- NCT05760248
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 13
- From May 2023 to the primary completion date, Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
Lab values
- Subject has any medical condition or taking medications that affects clotting and/or platelet function
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | New Brighton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.