15 mg CBL-514 per injection for Dercum's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Karen L. Herbst, MD, PC, Tucson, AZ
Dercum's Disease+1 More
15 mg CBL-514 per injection - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This Phase 2 study will be an open-label and randomized study to assess the efficacy and safety of CBL-514 in participants with Dercum's Disease lipomas.

Eligible Conditions

  • Dercum's Disease

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 0-84 days

0-84 days
Change in general quality of life (QOL) following CBL-514 injection into lipomas in participants with Dercum's disease.
Change in pain of individual lipomas following CBL-514 injection in participants with Dercum's disease.
Change in psychological quality of life (QOL) following CBL-514 injection into lipomas in participants with Dercum's disease.
Efficacy of CBL-514 following injection into lipomas or nodules of participants with Dercum's disease.
Improvement in general quality of life (QOL) following CBL-514 injection into lipomas in participants with Dercum's disease.
Improvement in pain of individual lipomas following CBL-514 injection in participants with Dercum's disease.
Improvement in psychological quality of life (QOL) following CBL-514 injection into lipomas in participants with Dercum's disease.
The incidence of adverse events of special interests (AESI) as defined in the protocol.
The incidence of clinically significant abnormal findings as defined in the protocol.

Trial Safety

Trial Design

2 Treatment Groups

CBL-514 Group 1
1 of 2
CBL-514 Group 2
1 of 2
Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: 15 mg CBL-514 per injection · No Placebo Group · Phase 2

CBL-514 Group 1
Drug
Experimental Group · 1 Intervention: 10 mg CBL-514 per injection · Intervention Types: Drug
CBL-514 Group 2
Drug
Experimental Group · 1 Intervention: 15 mg CBL-514 per injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-84 days
Closest Location: Karen L. Herbst, MD, PC · Tucson, AZ
Photo of tucson 1Photo of tucson 2Photo of tucson 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Dercum's Disease
0 CompletedClinical Trials

Who is running the clinical trial?

Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
5 Previous Clinical Trials
192 Total Patients Enrolled
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
2 Previous Clinical Trials
85 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have confirmed Dercum's disease and/or fulfill the following clinical criteria of Dercum's disease in localized nodular form
You have pain in and around multiple lipomas.
You have at least 4 painful and well defined lipomas with a diameter of ≥1.0 cm and ≤6.0 cm as determined by ultrasound.
You are generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.