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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
No Placebo-Only Group

Summary

This trial tests CBL-514 injections in people with Dercum's Disease who have multiple painful lumps. The treatment involves injecting CBL-514 directly into these lumps to reduce their size or pain. The amount injected depends on the size of each lump.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
15 mg CBL-514 per injection
2022
Completed Phase 2
~20
10 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
538 Total Patients Enrolled
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
400 Total Patients Enrolled
~4 spots leftby Nov 2025
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