A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

Overseen By Shannon Wu

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Anticoagulants, Antiplatelets, CYP inhibitors, others

Disqualifiers: Pregnancy, Coagulation disorders, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as terfenadine, buspirone, fexofenadine, and any drugs that strongly affect liver enzymes, at least 2 days before and until 1 day after the study dose. If you are on these medications, you may need to pause them during the study.

Who Is on the Research Team?

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

Has at least 4 painful and well defined lipomas with a diameter of ≥1.0 cm and ≤6.0 cm as determined by ultrasound. Excluding lipomas in proximity to vulnerable anatomic structures, including the salivary glands, lymph nodes, muscles, and along the anatomic landmarks of the marginal mandibular nerve.

Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation.

You have pain in and around many lumps of fat in your body.

Exclusion Criteria

Participants requiring continual use of the following therapeutic agents during the study: terfenadine, buspirone, fexofenadine, any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk. If a participant requires the abovementioned therapeutic agents during the study for any reason, they should not be used for at least 2 days before dosing and until 1 day postdose.

You have had cosmetic procedures such as liposuction or laser therapy in the area being studied before or during the trial.

Participant who has undergone vaccination (including with a live-attenuated vaccine) within 14 days prior to administration of the IP.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 2 courses of CBL-514 injections into selected lipomas, with dosage based on lipoma size

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBL-514

How Is the Trial Designed?

Group I: CBL-514 Group 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

Eligible participants will be enrolled and randomized into one of 2 dose groups. Group 1 with 10 mg CBL-514 per injection.

CBL-514 is already approved in European Union, United States for the following indications:

Approved in European Union as CBL-514 for:

• Dercum's disease

Approved in United States as CBL-514 for:

• Dercum's disease

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+