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Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity | Clinical Trials | Clareo Health

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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

NCT05760248•10xBio, LLC

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Site #01

Rolling Meadows, Illinois, United States

Site #02

New Brighton, Minnesota, United States

Key Dates

Start Date

May 4, 2023

Primary Completion Date

January 22, 2025

Completion Date

January 22, 2025

Last Updated

June 29, 2025

Enrollment

ACTUAL participants

Conditions

Subcutaneous Fat Disorder

Interventions

10XB-101 Solution for Injection, 6.0%

DRUG

Placebo Solution for Injection (no active ingredient)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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