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Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

NCT05760248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-06-29

No results posted yet for this study

Summary

The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.

The main question it aims to answer is:

•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?

Participants will be:

* Be given injections every month for 5 months over the right and left flanks.
* Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.

Conditions

  • Subcutaneous Fat Disorder

Interventions

DRUG

10XB-101 Solution for Injection, 6.0%

The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.

DRUG

Placebo Solution for Injection (no active ingredient)

Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.

Sponsors & Collaborators

  • Therapeutics, Inc.

    collaborator INDUSTRY

  • 10xBio, LLC

    lead INDUSTRY

Principal Investigators

  • John Dobak, M.D. · 10xBio, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2025-01-22
Completion
2025-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05760248 on ClinicalTrials.gov