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 localized
nodular form. The final diagnosis of disease is in the opinion of the Investigator.
1. Chronic pain (>3 months) in the adipose tissue specific to the presence of
lipomas and/or. 2. Pain in and around multiple lipomas.
4. 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. The
selected lipomas to be treated must meet the following conditions at screening.
1. At least 4 lipomas among the 10 lipomas should have greatest dimension of ≥ 20
mm but ≤50 mm.
2. Pain level is ≥4 scores as assessed by Comparative Pain Scale.
3. 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.
4. Isolated form and not connected with other lipoma(s).
5. Generally considered healthy according to medical history, physical examination,
ECG, and laboratory evaluation.
6. 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.
Exclusion Criteria:
1. 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.
Note: Participants who are not of childbearing potential are not required to use
contraception. Females not of childbearing potential are defined as those who have
been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are
postmenopausal (defined as at least 50 years of age with ≥12 months of amenorrhea
with 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.
1. Madelung's disease: multiple symmetric lipomatosis only localized in the upper
body ie, shoulders, neck, or head.
2. Panniculitis: inflammation of the SC adipose tissue, characterized by tender
nodules and systemic signs.
3. Proteus syndrome: disproportionate and asymmetric overgrowth of skin, and fatty
and connective tissue.
4. PTEN hamartoma syndrome: multiple hamartomas which includes segmental
overgrowth, lipomatosis, arteriovenous malformation, and epidermal nevus.
5. Gardner syndrome: multiple digestive adenomas with osteomas and multiple skin
and soft tissue tumors.
4. Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet
therapy or medications or dietary supplements, which inhibit coagulation or platelet
aggregation.
5. 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.
6. 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:
1. 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).
2. 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.
Note: Participant with an eGFR ≥60 and <90 mL/min/1.73 m2 at screening should be
evaluated by the Investigator for pre-existing renal disease or associated
dysfunction. If mild decrease in eGFR is deemed not clinically significant or not
related to dysfunction by the Investigator, the participant will not be excluded
unless the Investigator deems it necessary.
7. 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.
8. Participant is undergoing chronic steroid or immunosuppressive therapy, with the
exception of oral steroid inhalation indicated for asthma management or topical
steroid application for skin conditions that are not directly applied to or
indirectly affect the treatment area.
9. 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.
10. 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:
1. Prior wound, scar tissue, or infection in the treated area.
2. Tattoo in the treated area.
11. Use of any analgesic including Cannabis within 14 days prior to Screening. 12. 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.
Note: If a participant needs to use the above mentioned therapeutic agents during
the study for any reason, these therapeutic agents should not be used at least for 2
days prior to dosing and until 1 day postdose.
13. Participant who has undergone the following procedures:
1. Liposuction or aesthetic surgery to the region to be treated before screening
or during the study,
2. 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.
14. Unable to receive local anesthesia.
15. Known allergies or sensitivities to the study drug or its components.
16. Use of other investigational drug or device within 12 weeks prior to screening.
