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

NCT05760248 | Completed Phase 2 FDA Drug

• 1 other identifier: 210-9452-201
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subcutaneous Fat Disorder

Keywords

Right and Left Flank Fat

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

10XB-101 Solution for Injection, 6.0%

EXPERIMENTAL

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%

Placebo Solution for Injection

PLACEBO COMPARATOR

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)

Interventions

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.

Also known as: 10xB-101, 6%

10XB-101 Solution for Injection, 6.0%

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.

Also known as: Vehicle solution

Placebo Solution for Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 10xBio, LLC: lead
• Therapeutics, Inc.: collaborator

Study Sites (2)

Site #01

Rolling Meadows, Illinois, 60008, United States

Location

Site #02

New Brighton, Minnesota, 55112, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• John Dobak, M.D.

  10xBio, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1:1 ratio
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active drug 6% vs Placebo

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 8, 2023
• Study Start: May 4, 2023
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)