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

NCT05154955 | Completed Phase 2 FDA Drug

• 1 other identifier: 210-9451-203
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (2)

• Clinician Submental Fat Scale (CSFS)

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

  24 weeks after final injection treatment

• Patient Submental Fat Scale (PSFS)

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

  24 weeks after final injection treatment

Study Arms (4)

10XB-101 Solution for Injection, 2.0%

EXPERIMENTAL

Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection, 3.0%

EXPERIMENTAL

Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection, 4.5%

EXPERIMENTAL

Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Drug: 10XB-101 Solution for Injection

10XB-101 Vehicle Solution for Injection

PLACEBO COMPARATOR

Participants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Drug: 10XB-101 Vehicle Solution for Injection

Interventions

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 Solution for Injection, 2.0%; 10XB-101 Solution for Injection, 3.0%; 10XB-101 Solution for Injection, 4.5%

10XB-101 Vehicle Solution for Injection DRUG

This is the placebo control

10XB-101 Vehicle Solution for Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 10xBio, LLC: lead

Study Sites (4)

Site 03

Encino, California, 91436, United States

Location

Site 02

San Diego, California, 92122, United States

Location

Site 01

San Diego, California, 92123, United States

Location

Site 04

Rolling Meadows, Illinois, 60008, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 13, 2021
• Study Start: October 19, 2021
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: June 29, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)