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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2025-01-22

Brief Summary

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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.

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Detailed Description

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

Conditions

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Subcutaneous Fat Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active drug 6% vs Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

1:1 ratio

Study Groups

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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.

Group Type EXPERIMENTAL

10XB-101 Solution for Injection, 6.0%

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo Solution for Injection (no active ingredient)

Intervention Type DRUG

Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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10xB-101, 6% Vehicle solution

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No