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

Phase 2

Active, not recruiting

• Conditions: Submental Fat
• Interventions: Drug: 10XB-101 Vehicle Solution for Injection; Drug: 10XB-101 Solution for Injection

• Registration Number: NCT05154955
• Lead Sponsor: 10xBio, LLC

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-19
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10XB-101 Vehicle Solution for Injection	10XB-101 Vehicle Solution for Injection	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.
10XB-101 Solution for Injection, 2.0%	10XB-101 Solution for Injection	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.
10XB-101 Solution for Injection, 3.0%	10XB-101 Solution for Injection	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.
10XB-101 Solution for Injection, 4.5%	10XB-101 Solution for Injection	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.

Primary Outcome Measures

Name	Time	Method
Clinician Submental Fat Scale (CSFS)	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
Patient Submental Fat Scale (PSFS)	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

Trial Locations

Locations (4)

Site 01; 🇺🇸 San Diego, California, United States

Site 04; 🇺🇸 Rolling Meadows, Illinois, United States

Site 03; 🇺🇸 Encino, California, United States

Site 02; 🇺🇸 San Diego, California, United States