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

10xBio

Status and phase: Completed; Phase 2

Conditions: Submental Fat

Treatments: Drug: 10XB-101 Solution for Injection; Drug: 10XB-101 Vehicle Solution for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05154955

210-9451-203

Details and patient eligibility

About

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).

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 4 patient groups, including a placebo group

10XB-101 Solution for Injection, 2.0%

Experimental group

Description:

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.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection, 3.0%

Experimental group

Description:

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.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection, 4.5%

Experimental group

Description:

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.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Vehicle Solution for Injection

Placebo Comparator group

Description:

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.

Treatment:

Drug: 10XB-101 Vehicle Solution for Injection