A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin (Double Chin)

A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04258761

Enrollment

Registered

2020-02-06

Start date

2019-10-10

Completion date

2022-08-31

Last updated

2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submental Fat

Brief summary

The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or melt this fat away.

Detailed description

About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.

Interventions

DRUG10XB-101 Solution for Injection

Active test article

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multi-center, open label, single ascending dose comparison.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subject is a male or non-pregnant female 18-65 years of age * Signed informed consent * Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline * Subject is in good general health

Exclusion criteria

* Loose skin or prominent platysmal bands in the neck or chin area * Recent treatment with anticoagulants * Presence of clinically significant health problems

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	24 weeks	Incidence (severity and causality) of any local and systemic Adverse Events
Local Skin Reactions (LSR)	24 weeks	At each time point, the number of subjects with presence (and severity) of the following LSRs on a 4 point scale (zero to 3), with a higher score indicating a worse outcome: erythema, edema, tenderness on palpation, bruising, pain, and stinging/burning

Secondary

Measure	Time frame	Description
Clinician Submental Fat Scale (CSFS)	24 weeks	Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome
Patient Submental Fat Scale (PSFS)	24 weeks	Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026