NCT05760248

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

A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: 10xBio, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subcutaneous Fat Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-05-04
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2023-03-08
• Last updated: 2025-06-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study