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

Primary Purpose

Subcutaneous Fat Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
10XB-101 Solution for Injection, 6.0%
Placebo Solution for Injection (no active ingredient)
Sponsored by
10xBio, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subcutaneous Fat Disorder focused on measuring Right and Left Flank Fat

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site #01Recruiting
  • Site #02Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

10XB-101 Solution for Injection, 6.0%

Placebo Solution for Injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
May 22, 2023
Sponsor
10xBio, LLC
Collaborators
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05760248
Brief Title
Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity
Official Title
A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
October 28, 2024 (Anticipated)
Study Completion Date
December 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
10xBio, LLC
Collaborators
Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subcutaneous Fat Disorder
Keywords
Right and Left Flank Fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Active drug 6% vs Placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
1:1 ratio
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10XB-101 Solution for Injection, 6.0%
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Solution for Injection
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
10XB-101 Solution for Injection, 6.0%
Other Intervention Name(s)
10xB-101, 6%
Intervention Description
The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Solution for Injection (no active ingredient)
Other Intervention Name(s)
Vehicle solution
Intervention Description
Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.
Primary Outcome Measure Information:
Title
Volumetric measurements
Description
Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment.
Time Frame
24 weeks after final injection treatment
Title
Flank Skin Laxity Scale (FSLS)
Description
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.
Time Frame
24 weeks after final injection treatment
Title
Clinician Global Impression of Change (CGIC)
Description
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.
Time Frame
24 weeks after final injection treatment
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
24 weeks after final injection treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marietta Radona, M.D.
Phone
858-571-1800
Email
ClinicalResearch@therapeuticsinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Dobak, M.D.
Organizational Affiliation
10xBio, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Site #01
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marietta Radona, MD
Phone
858-571-1800
Email
ClinicalResearch@therapeuticsinc.com
Facility Name
Site #02
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marietta Radona, MD
Phone
898-571-1800
Email
ClinicalResearch@therapeuticsinc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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