10XB-101 Injections for Excess Side Fat

No longer recruiting at 1 trial location

Overseen By Marietta Radona, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: 10xBio, LLC

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Loose skin, Clotting issues, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an injection called 10XB-101 Solution for Injection to determine its safety and effectiveness in reducing side fat. Participants will receive either the test injection or a placebo over several months to compare results. The goal is to see if the injection reduces side fat more effectively than the placebo. Suitable candidates for this trial have maintained stable body weight for six months and have noticeable side fat that concerns them. Participants must also commit to attending clinic visits and receiving regular injections as part of the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that 10XB-101 is generally well-tolerated. Studies have found it effective, with fewer side effects lasting more than 30 days, meaning most people did not experience significant long-term issues. Additionally, findings suggest this treatment has fewer side effects and is easier for patients to manage compared to some other options. These results are promising, but it is important to remember that the current trial is still studying this treatment for safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for excess side fat?

10XB-101 is unique because it targets excess side fat through a new subcutaneous injection method, offering a localized treatment option. Unlike traditional methods like liposuction or non-invasive procedures like CoolSculpting, which can be more invasive or time-consuming, 10XB-101 provides a straightforward injection approach. Researchers are excited because this solution could offer a less invasive and more convenient option with the potential for consistent and effective fat reduction over a series of treatments.

What evidence suggests that 10XB-101 injections might be an effective treatment for excess side fat?

Research shows that the 10XB-101 Injection, which participants in this trial may receive, effectively reduces fat in specific areas. Studies have found it outperforms current body shaping treatments, offering faster results with fewer side effects. Previous research on a similar drug, ATX-101, successfully reduced fat under the chin, suggesting that 10XB-101 might also reduce fat on the sides. Experts have noted that 10XB-101 excels at reducing fat with minimal recovery time. These findings support the idea that 10XB-101 can effectively help decrease side fat. ^{1 2 3 4 5}

Who Is on the Research Team?

John Dobak, M.D.

Principal Investigator

10xBio, LLC

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: 10XB-101 Solution for Injection, 6.0% Experimental Treatment 1 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 Injection Placebo Group 1 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.

Who Is Running the Clinical Trial?

10xBio, LLC

Lead Sponsor

Trials

3

Recruited

80+

Therapeutics, Inc.

Industry Sponsor

Trials

31

Recruited

3,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05760248

NCT05760248 | Safety and Efficacy Study of 10XB-101 in ... 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 ...

2. 10xbio.com 10xbio.com/press-releases/10xbio-announces-data-from-interim-analysis-of-phase-2b-clinical-trial-showing-superior-efficacy-of-novel-drug-for-submental-body-contouring/

10xBio Announces Data from Interim Analysis of Phase 2b ... “The results of this study clearly demonstrated far superior efficacy and tolerability for 10XB101 than the currently marketed body contouring ...

3. withpower.com withpower.com/trial/phase-2-lipid-metabolism-disorders-4-2023-b8e90

10XB-101 Injections for 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.

4. community.the-hospitalist.org community.the-hospitalist.org/content/formulation-sclerotherapy-agent-found-useful-submental-fat-reduction

Formulation of Sclerotherapy Agent Found Useful for ... Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much ...

5. dermatologytimes.com dermatologytimes.com/view/late-breaking-phase-2b-data-showed-efficacy-of-injectable-polidocanol-for-submental-fat-reduction

Late-Breaking Phase 2b Data Showed Efficacy of ... The injectable polidocanol exhibited high efficacy, quicker onset of benefit, reduced downtime, and fewer side effects lasting longer than 30 days.