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

Inclusion Criteria:

1. Male or female, aged 18 years to 64 years old (at screening), inclusive.

2. Body mass index (BMI) >18.5 kg/m2 at screening and Day 1.

3. Has confirmed DD and/or fulfills the following clinical criteria of DD in localizednodular form. The final diagnosis of disease is in the opinion of the Investigator.

4. Chronic pain (>3 months) in the adipose tissue specific to the presence oflipomas and/or

5. Pain in and around multiple lipomas.

6. Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ≥10mm and ≤50 mm as measured by ultrasound (read by the Investigator) at screening. Theselected lipomas to be treated must meet the following conditions at screening.

7. At least 4 lipomas among the 10 lipomas should have greatest dimension of ≥ 20mm but ≤50 mm.

8. Pain level is ≥4 scores as assessed by Comparative Pain Scale.

9. Excluding lipomas in proximity to vulnerable anatomic structures, including thesalivary glands, lymph nodes, muscles, and along the anatomic landmarks of themarginal mandibular nerve.

10. Isolated form and not connected with other lipoma(s).

11. Generally considered healthy according to medical history, physical examination,ECG, and laboratory evaluation.

12. Voluntarily signs the informed consent form (ICF) and, in the opinion of theInvestigator or designee, is physically and mentally capable of participating in thestudy, and willing to adhere to study procedures.

Exclusion Criteria:

1. Female participant of childbearing potential who is not willing to commit to anacceptable contraceptive regimen from the time of screening and throughout studyparticipation until 90 days after the last IP dose, or who is currently pregnant orlactating. Female participant of childbearing potential who is breastfeeding oranticipates breastfeeding from the time of screening and throughout studyparticipation until 90 days after the last IP dose. Male participant who is notwilling to commit to using of a condom and refraining from sperm donation from thetime of the first dose of IP, throughout study participation until 90 days after thelast IP dose. Note: Participants who are not of childbearing potential are not required to usecontraception. Females not of childbearing potential are defined as those who havebeen surgically sterilized (hysterectomy or bilateral oophorectomy) or who arepostmenopausal (defined as at least 50 years of age with ≥12 months of amenorrheawith a follicle stimulating hormone >30 IU/L).

2. Unable to tolerate SC injections.

3. Diagnosed with another disorder with similar characteristics as DD as follows.

4. Madelung's disease: multiple symmetric lipomatosis only localized in the upperbody ie, shoulders, neck, or head.

5. Panniculitis: inflammation of the SC adipose tissue, characterized by tendernodules and systemic signs.

6. Proteus syndrome: disproportionate and asymmetric overgrowth of skin, and fattyand connective tissue.

7. PTEN hamartoma syndrome: multiple hamartomas which includes segmentalovergrowth, lipomatosis, arteriovenous malformation, and epidermal nevus.

8. Gardner syndrome: multiple digestive adenomas with osteomas and multiple skinand soft tissue tumors.

9. Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelettherapy or medications or dietary supplements, which inhibit coagulation or plateletaggregation.

10. 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, isinappropriate to participate in the study.

11. Any clinically significant cardiac, hepatic, renal or neurologic/psychiatricdisorders that in the opinion of the Investigator places the participant atsignificant risk, including but not limited to any of the following:

12. Participants with cirrhosis or with inadequate liver function at screeningdefined as aspartate aminotransferase (AST), alanine aminotransferase (ALT),alkaline phosphatase, or total bilirubin >3.0 upper limit of normal (ULN).

13. Participants with renal impairment, defined as both serum creatinine and bloodurea nitrogen >1.5× ULN, or estimated glomerular filtration rate (eGFR) <90mL/min/1.73 m2, or who are currently on dialysis. Note: Participant with an eGFR ≥60 and <90 mL/min/1.73 m2 at screening should beevaluated by the Investigator for pre-existing renal disease or associateddysfunction. If mild decrease in eGFR is deemed not clinically significant or notrelated to dysfunction by the Investigator, the participant will not be excludedunless the Investigator deems it necessary.

14. Participant with a history of human immunodeficiency virus (HIV)-1 infection orparticipant with active HIV infection at screening with positive HIVantigen/antibody (Ag/Ab) combo test.

15. Participant is undergoing chronic steroid or immunosuppressive therapy, with theexception of oral steroid inhalation indicated for asthma management or topicalsteroid application for skin conditions that are not directly applied to orindirectly affect the treatment area.

16. Participant with active or prior history of malignancies within 5 years beforescreening or currently being evaluated for a possible malignancy, with the exceptionof adequately treated basal cell carcinoma of skin and in situ squamous cellcarcinoma of skin at Investigator's discretion.

17. Abnormal skin, local skin conditions, or body modifications at the treatment area,which in the opinion of the Investigator, is inappropriate for participation in thestudy, including but not limited to any of the following:

18. Prior wound, scar tissue, or infection in the treated area.

19. Tattoo in the treated area.

20. Use of any analgesic including Cannabis within 14 days prior to Screening

21. Requiring continual use of any medication that is known to strongly inhibit orinduce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeuticindex during the study that, in the opinion of the Investigator, may affect theevaluation of the study product or place the participant at undue risk. Note: If a participant needs to use the above mentioned therapeutic agents duringthe study for any reason, these therapeutic agents should not be used at least for 2days prior to dosing and until 1 day postdose.

22. Participant who has undergone the following procedures:

23. Liposuction or aesthetic surgery to the region to be treated before screeningor during the study,

24. Aesthetic procedure for body contouring, eg, cryolipolysis, ultrasoniclipolysis, low level laser therapy, lipolysis injection to the region to betreated within 12 months before screening or during the study.

25. Unable to receive local anesthesia.

26. Known allergies or sensitivities to the study drug or its components.

27. Use of other investigational drug or device within 12 weeks prior to screening.