Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

Subcutaneous Fat Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05760248
• Other study ID #: 210-9452-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 4, 2023
• Est. completion date: December 26, 2024

Study information

• Verified date: March 2024
• Source: 10xBio, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: December 26, 2024
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Subcutaneous Fat Disorder

Intervention

Drug:
• 10XB-101 Solution for Injection, 6.0%
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)
Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.

Locations

Country	Name	City	State
United States	Site #02	New Brighton	Minnesota
United States	Site #01	Rolling Meadows	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
10xBio, LLC	Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks after final injection treatment
Primary	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.	24 weeks after final injection treatment
Primary	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.	24 weeks after final injection treatment
Primary	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.	24 weeks after final injection treatment