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Completed

NCT Number: NCT05760248

Safety and Efficacy Study of 10XB-101 in Adults 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.

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Key information

Conditions

Subcutaneous Fat Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site #01, Rolling Meadows, Illinois, United States

Loading trial locations.

About this study

Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

10XB-101 Solution for Injection, 6.0%

Drug

The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.

Other names: 10xB-101, 6%

Placebo Solution for Injection (no active ingredient)

Drug

Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.

Other names: Vehicle solution

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

10xBio, LLC

Industry

Collaborators

  • Therapeutics, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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