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

Sponsor
10xBio, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760248
Collaborator
Therapeutics, Inc. (Industry)
15
Enrollment
2
Arms
19.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 10XB-101 Solution for Injection, 6.0%
  • Drug: Placebo Solution for Injection (no active ingredient)
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Active drug 6% vs PlaceboActive drug 6% vs Placebo
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
1:1 ratio
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 28, 2024
Anticipated Study Completion Date :
Dec 26, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10XB-101 Solution for Injection, 6.0%

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%
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 Comparator: Placebo Solution for Injection

    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)
    Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
    Other Names:
  • Vehicle solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Volumetric measurements [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) [24 weeks after final injection treatment]

      Change from Baseline on each flank after final treatment . FSLS is a 4 point scale, with a higher score indicating higher severity

    3. Clinician Global Impression of Change (CGIC) [24 weeks after final injection treatment]

      Change from Baseline on each flank after final treatment. 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) [24 weeks after final injection treatment]

      Change from Baseline on each flank after final treatment. PGIC is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 10xBio, LLC
    • Therapeutics, Inc.

    Investigators

    • Study Chair: John Dobak, M.D., 10xBio, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    10xBio, LLC
    ClinicalTrials.gov Identifier:
    NCT05760248
    Other Study ID Numbers:
    • 210-9452-201
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 10xBio, LLC
    Right and Left Flank Fat
    Additional relevant MeSH terms:
    Lipid Metabolism Disorders
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Mar 8, 2023