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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks after final injection treatment
Awards & highlights

Study Summary

This trial tests if an injection drug is safe & effective for removing excess fat from the sides. Participants get injections & 13 visits spread over a year.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Global Impression of Change (CGIC)
Flank Skin Laxity Scale (FSLS)
Patient Global Impression of Change (PGIC)
+1 more

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

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.

Find a Location

Who is running the clinical trial?

10xBio, LLCLead Sponsor
2 Previous Clinical Trials
67 Total Patients Enrolled
Therapeutics, Inc.Industry Sponsor
30 Previous Clinical Trials
3,899 Total Patients Enrolled
John Dobak, M.D.Study Chair10xBio, LLC

Media Library

10XB-101 Solution for Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05760248 — Phase 2
Subcutaneous Fat Disorder Research Study Groups: 10XB-101 Solution for Injection, 6.0%, Placebo Solution for Injection
Subcutaneous Fat Disorder Clinical Trial 2023: 10XB-101 Solution for Injection Highlights & Side Effects. Trial Name: NCT05760248 — Phase 2
10XB-101 Solution for Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05760248 — Phase 2
Subcutaneous Fat Disorder Patient Testimony for trial: Trial Name: NCT05760248 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation being sought in this research effort?

"This medical study is open to participants who are in the 18-55 year old age bracket."

Answered by AI

How many participants have been included in this experiment?

"Affirmative. According to clinicaltrials.gov, the medical study in question is currently recruiting participants and was posted on May 4th 2023 with its last update being made on May 22nd of that year. A total of 15 volunteers are needed from two locations."

Answered by AI

Is it still feasible to join this experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavor is presently searching for participants and was initially revealed on May 4th 2023. The most recent edit took place on the 22nd of the same month. Participants will be recruited from two separate medical facilities with a total quota of 15 individuals."

Answered by AI

What criteria are necessary for potential participants to qualify for this medical experiment?

"Those who are accepted into this trial must have a subcutaneous fat disorder and be aged between 18-55 years old, with the total number of participants capped at 15."

Answered by AI

What possible adverse effects can arise from using 10XB-101 Solution for Injection, 6.0%?

"Although no clinical data exists to support 10XB-101 Solution for Injection, 6.0%'s efficacy, there is some that suggests that it may be safe. Hence, our team at Power gave the medication a rating of 2 on our safety scale from 1 to 3."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Site #01
Site #02
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am very self conscious of my flank fat, and no amount of diet or exercise makes a difference.
PatientReceived no prior treatments
I’m 50 and I’ve been a fat guy since forever. I’d like a chance to start over and see what it’s like to like the image looking back at me in the mirror.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity
2023. "Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05760248.
~4 spots leftby Oct 2024
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