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

10xBio

Status and phase: Completed; Phase 2

Conditions: Subcutaneous Fat Disorder

Treatments: Drug: Placebo Solution for Injection (no active ingredient); Drug: 10XB-101 Solution for Injection, 6.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT05760248

210-9452-201

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

10XB-101 Solution for Injection, 6.0%

Experimental group

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.

Treatment:

Drug: 10XB-101 Solution for Injection, 6.0%

Placebo Solution for Injection

Placebo Comparator group

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.

Treatment:

Drug: Placebo Solution for Injection (no active ingredient)