13 Participants Needed

10XB-101 Injections for Excess Side Fat

Recruiting at 1 trial location
MR
Overseen ByMarietta Radona, M.D.
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a special injection to reduce fat on both sides of the lower back. It targets people with excess fat in this area. The injection works by breaking down and removing the fat.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect clotting or platelet function.

What data supports the effectiveness of the drug 10XB-101 for reducing excess side fat?

Research on a similar drug, ATX-101, shows it is effective in reducing fat under the chin, suggesting that 10XB-101 might also help reduce fat in other areas.12345

How does the drug 10XB-101 differ from other treatments for excess side fat?

The drug 10XB-101 is unique because it is an injectable solution, similar to ATX-101, which is used for reducing submental fat. This type of treatment offers a nonsurgical option for fat reduction, which is different from traditional surgical methods like liposuction.13678

Research Team

JD

John Dobak, M.D.

Principal Investigator

10xBio, LLC

Eligibility Criteria

This trial is for adults aged 18-55 with stable body weight who have excess fat on both sides of their waist (bilateral flank adiposity). They must be willing to receive monthly injections, follow the study's instructions, and attend all visits over a year. Pregnant individuals or those with clotting issues, loose skin in the target area, or allergies to ingredients in the injection cannot participate.

Inclusion Criteria

Subject has provided written informed consent.
Subject has had a stable body weight for the past 6 months prior to starting study.
I am willing to follow the study's treatment plan and attend all required visits.
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Exclusion Criteria

Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
I have a condition or take medication that affects blood clotting.
Subject is pregnant, lactating, or is planning to become pregnant during the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of the study drug or placebo every 4 weeks for up to 6 treatments

5 months
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
7 visits (in-person), 3 visits (phone call)

Treatment Details

Interventions

  • 10XB-101 Solution for Injection
  • Placebo Solution for Injection (no active ingredient)
Trial Overview The trial tests an injectable drug called 10XB-101 against a placebo (no active ingredient) to see if it can safely reduce excess side waist fat. Participants will get injections every month for five months and will visit the clinic 13 times plus three phone calls across one year.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 10XB-101 Solution for Injection, 6.0%Experimental Treatment1 Intervention
Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.
Group II: Placebo Solution for InjectionPlacebo Group1 Intervention
Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.

Find a Clinic Near You

Who Is Running the Clinical Trial?

10xBio, LLC

Lead Sponsor

Trials
3
Recruited
80+

Therapeutics, Inc.

Industry Sponsor

Trials
31
Recruited
3,900+

References

Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. [2022]
Fat transfer--a "pinch" technique for accurate placement of donor tissue. [2019]
Randomized, Placebo-Controlled Phase 1/2 Study to Determine the Appropriate ATX-101 Concentration for Reduction of Submental Fat. [2023]
Complications of Lipostabil Endovena for treating localized fat deposits. [2022]
A Double-Blind, Placebo-Controlled, Phase 3b Study of ATX-101 for Reduction of Mild or Extreme Submental Fat. [2020]
Prevention and Management of Injection-Related Adverse Effects in Facial Aesthetics: Considerations for ATX-101 (Deoxycholic Acid Injection) Treatment. [2017]
Histological Analysis of the Effect of ATX-101 (Deoxycholic Acid Injection) on Subcutaneous Fat: Results From a Phase 1 Open-Label Study. [2021]
Proper Technique for Administration of ATX-101 (Deoxycholic Acid Injection): Insights From an Injection Practicum and Roundtable Discussion. [2017]