What side effects are associated with this type of intervention?

Injectable lipolytic agents used to treat Subcutaneous Fat Disorder commonly cause localized side effects such as pain, swelling, bruising, and redness at the injection site. Less common but more serious side effects include infection, necrosis of the injected fat, contour irregularities, and fat emboli, which can lead to severe complications like stroke or vision loss.

What prior FDA approvals exist?

The FDA has approved several treatments for subcutaneous fat disorders that involve breaking down fat cells to reduce adiposity. One notable example is deoxycholic acid (Kybella), an injectable treatment that destroys fat cells in the submental area (under the chin). Other treatments include various liposuction techniques and non-invasive procedures like cryolipolysis (CoolSculpting), which also target and reduce fat cells. These treatments share a common goal of reducing localized fat deposits, similar to the injectable lipolytic agents being studied in clinical trials.

What other types of research exist?

Promising novel alternatives to injectable lipolytic agents for subcutaneous fat disorder patients include: 1) PCSK9 inhibitors, which have shown potential in reducing adiposity through cholesterol metabolism modulation. 2) Glucagon-like peptide-1 (GLP-1) receptor agonists, which can promote weight loss and improve metabolic profiles. 3) Cell therapy with allogeneic cardiosphere-derived cells (CDCs), which have demonstrated anti-inflammatory effects and potential in reducing adiposity. These alternatives are in various stages of clinical development and have shown promising results in preliminary studies.

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Other

10XB-101 Injections for Excess Side Fat

Phase 2

Waitlist Available

Research Sponsored by 10xBio, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is a male or non-pregnant female 18 to 55 years old.

Be between 18 and 65 years old

Must not have

Subject has any medical condition or taking medications that affects clotting and/or platelet function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks after final injection treatment

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common reactions may include discomfort at injection site, potential allergic reactions to ingredients if sensitivity exists, and other typical risks associated with medical injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 55 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition or take medication that affects blood clotting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks after final injection treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks after final injection treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks after final injection treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Global Impression of Change (CGIC)

Flank Skin Laxity Scale (FSLS)

Patient Global Impression of Change (PGIC)

+1 more

Trial Design

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Subcutaneous Fat Disorder often involve mechanisms that target the breakdown of fat cells (lipolysis) to reduce adiposity. Injectable lipolytic agents, for example, work by breaking down triglycerides stored in fat cells into free fatty acids and glycerol, which are then metabolized by the body. This process reduces the volume of subcutaneous fat. Other treatments may include agents that modulate hormone-sensitive lipase or adipose triglyceride lipase, enhancing the body's natural fat breakdown processes. These mechanisms are crucial for patients as they offer targeted, minimally invasive options to manage and reduce unwanted fat deposits, improving both physical appearance and metabolic health.

Long residence time adenosine A1 receptor agonists produce sustained wash-resistant antilipolytic effect in rat adipocytes.Adipogenic and lipolytic effects of chronic glucocorticoid exposure.