Dercum's DiseasePhase 2NCT06303570
A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas
A Phase 2 study testing CBL-514 injection and 0.9% Sodium chloride in people with Dercum's Disease, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in United States.
Trial summary
This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Dercum's Disease
- What is being tested?
- CBL-514 injection and 0.9% Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 14 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 18 years to 64 years old (at screening), inclusive.
- Body mass index (BMI) >18.5 kg/m2 at screening and Day 1.
- Has confirmed DD and/or fulfills the following clinical criteria of DD in localized nodular form. The final diagnosis of disease is in the opinion of the Investigator.
- Chronic pain (>3 months) in the adipose tissue specific to the presence of lipomas and/or
- Pain in and around multiple lipomas.
- Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ≥10 mm and ≤50 mm as measured by ultrasound (read by the Investigator) at screening.
- Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation.
- Voluntarily signs the informed consent form (ICF) and, in the opinion of the Investigator or designee, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
Who cannot join
- Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Female participant of childbearing potential who is breastfeeding or anticipates breastfeeding from the time of screening and throughout study participation until 90 days after the last IP dose. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
- Unable to tolerate SC injections.
- Diagnosed with another disorder with similar characteristics as DD as follows.
- Madelung's disease: multiple symmetric lipomatosis only localized in the upper body ie, shoulders, neck, or head.
- Panniculitis: inflammation of the SC adipose tissue, characterized by tender nodules and systemic signs.
- Proteus syndrome: disproportionate and asymmetric overgrowth of skin, and fatty and connective tissue.
Show all 28Show fewer
- PTEN hamartoma syndrome: multiple hamartomas which includes segmental overgrowth, lipomatosis, arteriovenous malformation, and epidermal nevus.
- Gardner syndrome: multiple digestive adenomas with osteomas and multiple skin and soft tissue tumors.
- Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation.
- Has fasting glucose concentration >200 mg/dL, delayed wound healing, bleeding risk, or any diabetic risks which, in the opinion of the Investigator or designee, is inappropriate to participate in the study.
- Any clinically significant cardiac, hepatic, renal or neurologic/psychiatric disorders that in the opinion of the Investigator places the participant at significant risk, including but not limited to any of the following:
- Participants with cirrhosis or with inadequate liver function at screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin >3.0 upper limit of normal (ULN).
- Participants with renal impairment, defined as both serum creatinine and blood urea nitrogen >1.5× ULN, or estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2, or who are currently on dialysis.
- Participant with a history of human immunodeficiency virus (HIV)-1 infection or participant with active HIV infection at screening with positive HIV antigen/antibody (Ag/Ab) combo test.
- Participant is undergoing chronic steroid or immunosuppressive therapy, with the exception of:
- Use of oral steroid inhalation indicated for asthma management
- Use of topical steroid application for skin conditions that are not directly applied to or indirectly affect the treatment area
- Use of steroid as part of treatment for DD, and no side effects from chornic use.
- Participant with active or prior history of malignancies within 5 years before screening or currently being evaluated for a possible malignancy, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator's discretion.
- Abnormal skin, local skin conditions, or body modifications at the treatment area, which in the opinion of the Investigator, is inappropriate for participation in the study, including but not limited to any of the following:
- Prior wound, scar tissue, or infection in the treated area.
- Tattoo in the treated area.
- Use of any analgesic except Cannabis within 2 days prior to Day 1 and use of Cannabis within 14 days prior to Day 1.
- Requiring continual use of any medication that is known to strongly inhibit or induce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk.
- Participant who has undergone liposuction or aesthetic surgery to the region to be treated before screening or during the study, or aesthetic procedure for body contouring (eg, cryolipolysis, ultrasonic lipolysis, low level laser therapy, lipolysis injection) to the region to be treated within 12 months before screening or during the study.
- Unable to receive local anesthesia.
- Known allergies or sensitivities to the study drug or its components.
- Use of other investigational drug or device within 12 weeks prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Blind, Placebo-Control, Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.
Read the detailed description
This is a phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's disease lipomas.
A total of approximately 25 participants will be randomized. Eligible participants will be randomized (1:1) to receive either CBL-514 or placebo once every 4 weeks for up to 5 treatments for each selected lipoma. Participant numbers are expected to be approximately balanced in each dose group (CBL-514 group and placebo group). Eligible participants must have at least 4 and up to 10 painful individual lipomas. The injection volume per lipoma will depend on the lipoma size (as determined by ultrasound).
- Conditions
- Dercum's Disease
- Being tested
- CBL-514 injection, 0.9% Sodium chloride
- Keywords
- Adiposis Dolorosa, Lipedema, Lipomatosis, Skin Diseases, Lipid Metabolism Disorders, Metabolism Diseases, Connective Tissue Diseases
- Medical subject headings
- Adiposis Dolorosa, Lipedema, Lipomatosis, Skin Diseases, Lipid Metabolism Disorders, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL-514 injectionDrug
The total injection volume per lipoma will based on the lipoma size,as determined by ultrasound. Dosing scheme is presented as below:
Lipoma diameter of >0mm and <10mm - total injection volume per lipoma: 1 mL ; total of 5 mg CBL-514.
Lipoma diameter of ≥10mm and ≤20mm - total injection volume per lipoma: 3 mL ; total of 15 mg CBL-514.
Lipoma diameter of >20mm and ≤30mm - total injection volume per lipoma: 5 mL ; total of 25 mg CBL-514.
Lipoma diameter of >30mm and ≤40mm - total injection volume per lipoma: 8 mL ; total of 40 mg CBL-514.
Lipoma diameter of >40mm and ≤50mm - total injection volume per lipoma: 12 mL ; total of 60 mg CBL-514.
0.9% Sodium chlorideDrug
The total injection volume per lipoma will based on the lipoma size,as determined by ultrasound. Dosing scheme is presented as below:
Lipoma diameter of >0mm and <10mm - total injection volume per lipoma: 1 mL.
Lipoma diameter of ≥10mm and ≤20mm - total injection volume per lipoma: 3 mL.
Lipoma diameter of >20mm and ≤30mm - total injection volume per lipoma: 5 mL.
Lipoma diameter of >30mm and ≤40mm - total injection volume per lipoma: 8 mL.
Lipoma diameter of >40mm and ≤50mm - total injection volume per lipoma: 12 mL.
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 injection | Experimental | Eligible participants will receive CBL-514 administered in doses ranging from 1 mL to a maximum of 12 mL per lipoma, with treatments scheduled at intervals of approximately 4 weeks, up to 5 treatments. Receives: Drug: CBL-514 injection |
| 0.9% Sodium Chloride | Placebo comparator | Eligible participants will receive 0.9% Sodium Chloride administered in doses ranging from 1 mL to a maximum of 12 mL per lipoma, with treatments scheduled at intervals of approximately 4 weeks, up to 5 treatments. Receives: Drug: 0.9% Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD.
The Comparative Pain Scale is a 11-point scale (0-10) to assess pain from 0 being "pain free" to 10 being unimaginable/unspeakable pain.
Measured: Week 20
Secondary outcomes (3)
To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD.
The Comparative Pain Scale is a 11-point scale (0-10) to assess pain from 0 being "pain free" to 10 being unimaginable/unspeakable pain.
Measured: Up to 24 weeks
To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol.
Adverse events (AEs) will be assessed by recording of clinical responses (e.g. treatment-emergent adverse events (TEAEs), and injection site reactions (ISRs)).
Measured: From baseline to 8 weeks post final treatment
To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol.
Assessed by significant clinical changes in safety parameter (e.g. laboratory assessments, vital signs, ECGs, physical examinations).
Measured: From baseline to 8 weeks post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Nov 2024
- Primary completion23 Mar 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dercum's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303570
- Sponsor's protocol ID
- CBL-0202DD
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Placebo-Control, Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
- ClinicalTrials.gov ID
- NCT06303570
- Acronym / sponsor ID
- CBL-0202DD
- Conditions
- Dercum's Disease
- Keywords
- Adiposis Dolorosa, Lipedema, Lipomatosis, Skin Diseases, Lipid Metabolism Disorders, Metabolism Diseases, Connective Tissue Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.
Detailed description
This is a phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's disease lipomas.
A total of approximately 25 participants will be randomized. Eligible participants will be randomized (1:1) to receive either CBL-514 or placebo once every 4 weeks for up to 5 treatments for each selected lipoma. Participant numbers are expected to be approximately balanced in each dose group (CBL-514 group and placebo group). Eligible participants must have at least 4 and up to 10 painful individual lipomas. The injection volume per lipoma will depend on the lipoma size (as determined by ultrasound).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBL-514 injection | Experimental | Drug: CBL-514 injectionEligible participants will receive CBL-514 administered in doses ranging from 1 mL to a maximum of 12 mL per lipoma, with treatments scheduled at intervals of approximately 4 weeks, up to 5 treatments. |
| 0.9% Sodium Chloride | Placebo comparator | Drug: 0.9% Sodium chlorideEligible participants will receive 0.9% Sodium Chloride administered in doses ranging from 1 mL to a maximum of 12 mL per lipoma, with treatments scheduled at intervals of approximately 4 weeks, up to 5 treatments. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, aged 18 years to 64 years old (at screening), inclusive.
- Body mass index (BMI) >18.5 kg/m2 at screening and Day 1.
- Has confirmed DD and/or fulfills the following clinical criteria of DD in localized nodular form. The final diagnosis of disease is in the opinion of the Investigator.
- Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ≥10 mm and ≤50 mm as measured by ultrasound (read by the Investigator) at screening.
- Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation.
Key exclusion criteria (28 listed)
- Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Female participant of childbearing potential who is breastfeeding or anticipates breastfeeding from the time of screening and throughout study participation until 90 days after the last IP dose. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
- Unable to tolerate SC injections.
- Diagnosed with another disorder with similar characteristics as DD as follows.
- Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation.
- Has fasting glucose concentration >200 mg/dL, delayed wound healing, bleeding risk, or any diabetic risks which, in the opinion of the Investigator or designee, is inappropriate to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL-514 injectionThe total injection volume per lipoma will based on the lipoma size,as determined by ultrasound. Dosing scheme is presented as below: Lipoma diameter of >0mm and <10mm - total injection volume per lipoma: 1 mL ; total of 5 mg CBL-514. Lipoma diameter of ≥10mm and ≤20mm - total injection volume per lipoma: 3 mL ; total of 15 mg CBL-514. Lipoma diameter of >20mm and ≤30mm - total injection volume per lipoma: 5 mL ; total of 25 mg CBL-514. Lipoma diameter of >30mm and ≤40mm - total injection volume per lipoma: 8 mL ; total of 40 mg CBL-514. Lipoma diameter of >40mm and ≤50mm - total injection volume per lipoma: 12 mL ; total of 60 mg CBL-514. | Drug | CBL-514 injection |
| 0.9% Sodium chlorideThe total injection volume per lipoma will based on the lipoma size,as determined by ultrasound. Dosing scheme is presented as below: Lipoma diameter of >0mm and <10mm - total injection volume per lipoma: 1 mL. Lipoma diameter of ≥10mm and ≤20mm - total injection volume per lipoma: 3 mL. Lipoma diameter of >20mm and ≤30mm - total injection volume per lipoma: 5 mL. Lipoma diameter of >30mm and ≤40mm - total injection volume per lipoma: 8 mL. Lipoma diameter of >40mm and ≤50mm - total injection volume per lipoma: 12 mL. | Drug | 0.9% Sodium Chloride |
Primary outcome
To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD.
Time frame: Week 20
The Comparative Pain Scale is a 11-point scale (0-10) to assess pain from 0 being "pain free" to 10 being unimaginable/unspeakable pain.
3 secondary outcomes
To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD.
Time frame: Up to 24 weeks
To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol.
Time frame: From baseline to 8 weeks post final treatment
To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol.
Time frame: From baseline to 8 weeks post final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBL-514 injection and 0.9% Sodium chloride in people with Dercum's Disease, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD. (time frame: Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.