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Completed

NCT Number: NCT05154955

A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat

The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).

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Key information

Conditions

Submental Fat

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 03, Encino, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is a male or non-pregnant female 18 to 65 years old.
  • Subject has provided written informed consent.
  • Subject has qualifying Submental Fat evaluation score.
  • 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 submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator.
  • Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery).
  • Subject has any medical condition 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.

Treatment and study plan

10XB-101 Solution for Injection

Drug

One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.

10XB-101 Vehicle Solution for Injection

Drug

This is the placebo control

Primary outcomes

  1. Clinician Submental Fat Scale (CSFS)

    Time frame: 24 weeks after final injection treatment

    Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity

  2. Patient Submental Fat Scale (PSFS)

    Time frame: 24 weeks after final injection treatment

    Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity

Sponsors and collaborators

Lead sponsor

10xBio, LLC

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2021
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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