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CBL-514 40mg for Cellulite

Phase 2
Waitlist Available
Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks from treatment visit
Awards & highlights

Study Summary

This trial tests a new drug to see if it can help people with cellulite, and looks at how safe and effective it is.

Eligible Conditions
  • Cellulite

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks from treatment visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks from treatment visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of the improvement of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.
Secondary outcome measures
Percentage of participants' thighs that achieve at least 1-level severity improvement measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.
Other outcome measures
Incidence of adverse events and treatment-emergent adverse events (TEAEs)
Incidence of adverse events and treatment-emergent adverse events (TEAEs) at the injection site(s)
Incidence of adverse events and treatment-emergent adverse events (TEAEs) related to the investigational product (IP)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: CBL-514 80mgExperimental Treatment1 Intervention
Group II: CBL-514 60mgExperimental Treatment1 Intervention
Group III: CBL-514 40mgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
40 mg CBL-514
2023
Completed Phase 2
~20
60 mg CBL-514
2023
Completed Phase 2
~20
80 mg CBL-514
2023
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
525 Total Patients Enrolled
1 Trials studying Cellulite
23 Patients Enrolled for Cellulite
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
387 Total Patients Enrolled
1 Trials studying Cellulite
23 Patients Enrolled for Cellulite

Frequently Asked Questions

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

Is enrollment still open for this clinical investigation?

"According to information published on clinicaltrials.gov, the trial is not open for recruitment at this time. It was first posted on September 1st 2023 and last updated November 21st 2022; however, there are five other trials currently recruiting participants."

Answered by AI

Which individuals would be ideal candidates for this trial?

"This clinical trial is looking to enrol 12 adults between 18 and 64 years old who have cellulite. To qualify, the patient must possess a BMI from 18.5 kg/m2 to 35 kg/m2, weigh at least 50kgs, demonstrate stable lifestyle behaviours for 3 months prior and during the study, provide informed consent forms indicating physical and mental competency, display 4-8 points on Hexsel CSS scales regarding depressions in posterolateral thighs when assessed by modified Hexsel CSS scale."

Answered by AI

Does the research allow elderly participants aged 85 and over to participate?

"This research is open to individuals between 18 and 64 years of age."

Answered by AI

Is CBL-514 80mg permitted by the FDA for therapeutic use?

"There is limited data to support the safety of CBL-514 80mg, so it was given a rating of 2 by our team at Power. Since this trial is Phase 2 there are no reported results about its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
What site did they apply to?
Investigational Site 1
Investigational Site 2
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 have horrible cellulite. I've always had cellulite and I'm interested in finding a solution.
PatientReceived 2+ prior treatments
~5 spots leftby Apr 2025