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.

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

8. 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.

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.

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:

16. Use of oral steroid inhalation indicated for asthma management

17. Use of topical steroid application for skin conditions that are not directlyapplied to or indirectly affect the treatment area

18. Use of steroid as part of treatment for DD, and no side effects from chornicuse.

19. 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.

20. 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:

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

22. Tattoo in the treated area.

23. Use of any analgesic except Cannabis within 2 days prior to Day 1 and use ofCannabis within 14 days prior to Day 1.

24. 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.

25. Participant who has undergone liposuction or aesthetic surgery to the region to betreated before screening or during the study, or aesthetic procedure for bodycontouring (eg, cryolipolysis, ultrasonic lipolysis, low level laser therapy,lipolysis injection) to the region to be treated within 12 months before screeningor during the study.

26. Unable to receive local anesthesia.

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

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