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15 mg CBL-514 per injection for Adiposis Dolorosa

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 0-84 days
Awards & highlights

Study Summary

This trial will assess a new drug for Dercum's Disease, which is a condition that causes fatty growths on the body.

Eligible Conditions
  • Adiposis Dolorosa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-84 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Efficacy of CBL-514 following injection into lipomas or nodules of participants with Dercum's disease.
The change in pain of individual lipomas following CBL-514 injection in participants with Dercum's disease.
The incidence of adverse events of special interests (AESI) as defined in the protocol.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: CBL-514 Group 2Experimental Treatment1 Intervention
Eligible participants will be enrolled and randomized to one of 2 dose groups. Group 2 with 15 mg CBL-514 per injection.
Group II: CBL-514 Group 1Experimental Treatment1 Intervention
Eligible participants will be enrolled and randomized into one of 2 dose groups. Group 1 with 10 mg CBL-514 per injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
10 mg CBL-514 per injection
2022
Completed Phase 2
~20
15 mg CBL-514 per injection
2022
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 Adiposis Dolorosa
30 Patients Enrolled for Adiposis Dolorosa
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
387 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial open to individuals aged sixty or above?

"The requirements for enrolment in this trial state that the age of participants must be between 18 and 64 years old."

Answered by AI

What perils are associated with a 15 mg dosage of CBL-514 administered via injection?

"Although yet to be proven efficacious, 15 mg CBL-514 per injection has some clinical evidence of safety and was thus awarded a score of 2."

Answered by AI

Are participants still being sought for this research endeavor?

"Affirmative. Documents hosted on clinicaltrials.gov corroborate that this study, which was initially posted on October 3rd 2022, is actively recruiting participants. A dozen patients need to be sourced from 1 medical centre."

Answered by AI

What is the upper limit for participant enrollment in this trial?

"Yes, according to clinicaltrials.gov the trial is currently recruiting patients. The original post was published on October 3rd 2022 and the information has been recently updated on October 31st 2022. They require 12 participants at 1 site."

Answered by AI

Could I potentially qualify to participate in this clinical experiment?

"This trial is recruiting 12 individuals aged 18 to 64 with Dercum's disease. Eligibility criteria include a BMI greater than 18.5, having at least 4 defined lipomas in the adipose tissue which are painful and between 1-6 cm in diameter, being medically healthy according to history, physical exam and lab results, agreeing to study procedures by signing an ICF form as well as meeting certain mental and physical requirements deemed suitable by the Principal Investigator or their designee."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Kentucky
Nevada
How old are they?
18 - 65
What site did they apply to?
Karen L. Herbst, MD, PC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Is it available or possible to do the trial in South Africa?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Given it's a rare disease with a little treatment option, I am hoping for some relief.
PatientReceived no prior treatments
I have had this condition for over 20 years and was diagnosed with DD by Dr. Herbst in 2009.
PatientReceived no prior treatments
I've extreme pain in lipomas. Tried consulting different doctors but they didn't help at all.
PatientReceived 1 prior treatment
I am on the highest level of pain management meds , don't want to continue taking medication without seeing results.
PatientReceived no prior treatments
I need to stop those angiolipomas developing, the pain to stop and live a quality life,also to help others with the same condition.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
2022. "A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387733.
~5 spots leftby Apr 2025
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