Lipoma
Conditions
Brief summary
The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.
Detailed description
A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
Interventions
Administered via intralipomal injection.
DRUGPlacebo
Matching vehicle placebo administered via intralipomal injection.
Sponsors
Kythera Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics: * History of slow growth followed by dormancy, and stable for at least 6 months * Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive * Discrete, oval to rounded in shape, not hard or attached to underlying tissue * Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation) * Located on the trunk, arms, legs, or neck * Signed informed consent.
Exclusion criteria
* Absence of significant medical conditions that could affect safety * History of surgical or deoxycholate treatment for lipomas * Treatment with an investigational agent within 30 days before ATX-101 treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | 24 weeks | An abnormality is defined as a value outside the limits of the expanded normal range/notable range. |
| Number of Participants With Positive Histopathology Results at Screening | Screening (prior to randomization) | A needle core tissue sample biopsy was performed at screening for all treated lipomas. |
| Number of Participants With Positive Histopathology Results at Week 20 | Week 20 | After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised. |
| Number of Participants With Adverse Events (AEs) | Up to 24 weeks | Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: Was there a reasonable possibility that the event may have been caused by treatment with study material? A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard. |
| Number of Participants With Clinically Significant Changes in Vital Signs or Weight | Up to 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment) | Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area \* 100. A positive change indicates a reduction in size. |
| Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Baseline and week 20 (8 weeks after last dose) | At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with \> 1 target lipoma, the total area of all target lipomas was used in the calculation of response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deoxycholic Acid 1% Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 15 |
| Deoxycholic Acid 2% Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 15 |
| Deoxycholic Acid 4% Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 14 |
| Placebo Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 17 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Participant's Request | 0 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 9.5 | 48.5 years STANDARD_DEVIATION 9.1 | 49.5 years STANDARD_DEVIATION 10.5 | 45.5 years STANDARD_DEVIATION 8.9 | 47.2 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 3 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 11 Participants | 11 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 15 | 13 / 15 | 14 / 15 | 12 / 17 |
| serious Total, serious adverse events | 1 / 15 | 0 / 15 | 1 / 15 | 0 / 17 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: Was there a reasonable possibility that the event may have been caused by treatment with study material? A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Time frame: Up to 24 weeks
Population: Safety population (all participants who received at least 1 dose of study medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 1% | Number of Participants With Adverse Events (AEs) | Any adverse event | 12 participants |
| Deoxycholic Acid 1% | Number of Participants With Adverse Events (AEs) | Any adverse event leading to drug discontinuation | 1 participants |
| Deoxycholic Acid 1% | Number of Participants With Adverse Events (AEs) | Any serious adverse event | 1 participants |
| Deoxycholic Acid 1% | Number of Participants With Adverse Events (AEs) | Any treatment-related adverse event | 6 participants |
| Deoxycholic Acid 1% | Number of Participants With Adverse Events (AEs) | Any severe adverse event | 1 participants |
| Deoxycholic Acid 2% | Number of Participants With Adverse Events (AEs) | Any adverse event | 13 participants |
| Deoxycholic Acid 2% | Number of Participants With Adverse Events (AEs) | Any treatment-related adverse event | 9 participants |
| Deoxycholic Acid 2% | Number of Participants With Adverse Events (AEs) | Any adverse event leading to drug discontinuation | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Adverse Events (AEs) | Any serious adverse event | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Adverse Events (AEs) | Any severe adverse event | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Adverse Events (AEs) | Any adverse event leading to drug discontinuation | 3 participants |
| Deoxycholic Acid 4% | Number of Participants With Adverse Events (AEs) | Any serious adverse event | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Adverse Events (AEs) | Any adverse event | 14 participants |
| Deoxycholic Acid 4% | Number of Participants With Adverse Events (AEs) | Any severe adverse event | 2 participants |
| Deoxycholic Acid 4% | Number of Participants With Adverse Events (AEs) | Any treatment-related adverse event | 8 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Any treatment-related adverse event | 7 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Any adverse event | 12 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Any severe adverse event | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Any adverse event leading to drug discontinuation | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Any serious adverse event | 0 participants |
Primary
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Time frame: Up to 24 weeks
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid 1% | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | 0 participants |
| Deoxycholic Acid 4% | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | 0 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | 0 participants |
Primary
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Time frame: 24 weeks
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 1% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Blood triglycerides | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alkaline phosphatase | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Urinalysis - Glucose | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alanine transaminase | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Aspartate aminotransferase | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Aspartate aminotransferase | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alkaline phosphatase | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Blood triglycerides | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alanine transaminase | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Urinalysis - Glucose | 0 participants |
| Deoxycholic Acid 4% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Aspartate aminotransferase | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alanine transaminase | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Blood triglycerides | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alkaline phosphatase | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Urinalysis - Glucose | 1 participants |
| Placebo | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alkaline phosphatase | 0 participants |
| Placebo | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Alanine transaminase | 0 participants |
| Placebo | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Blood triglycerides | 0 participants |
| Placebo | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Aspartate aminotransferase | 0 participants |
| Placebo | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | Urinalysis - Glucose | 0 participants |
Primary
Number of Participants With Positive Histopathology Results at Screening
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Time frame: Screening (prior to randomization)
Population: Safety population with biopsy results at screening
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Screening | Hemorrhage | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Screening | Chronic inflammation | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Screening | Fibrosis/scarring | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Screening | Acute inflammation | 0 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Screening | Mature adipose tissue | 11 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Screening | Necrosis | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Screening | Mature adipose tissue | 11 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Screening | Necrosis | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Screening | Acute inflammation | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Screening | Fibrosis/scarring | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Screening | Chronic inflammation | 0 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Screening | Hemorrhage | 0 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Screening | Acute inflammation | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Screening | Mature adipose tissue | 13 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Screening | Hemorrhage | 2 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Screening | Chronic inflammation | 0 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Screening | Fibrosis/scarring | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Screening | Necrosis | 0 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Screening | Necrosis | 0 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Screening | Chronic inflammation | 0 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Screening | Fibrosis/scarring | 0 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Screening | Hemorrhage | 1 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Screening | Mature adipose tissue | 13 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Screening | Acute inflammation | 0 participants |
Primary
Number of Participants With Positive Histopathology Results at Week 20
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
Time frame: Week 20
Population: Safety population with biopsy results at week 20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Week 20 | Necrosis | 14 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Week 20 | Fibrosis/scarring | 13 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Week 20 | Acute inflammation | 3 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Week 20 | Chronic inflammation | 10 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Week 20 | Hemorrhage | 5 participants |
| Deoxycholic Acid 1% | Number of Participants With Positive Histopathology Results at Week 20 | Mature adipose tissue | 15 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Week 20 | Mature adipose tissue | 13 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Week 20 | Acute inflammation | 2 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Week 20 | Chronic inflammation | 12 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Week 20 | Hemorrhage | 5 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Week 20 | Necrosis | 13 participants |
| Deoxycholic Acid 2% | Number of Participants With Positive Histopathology Results at Week 20 | Fibrosis/scarring | 12 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Week 20 | Necrosis | 14 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Week 20 | Acute inflammation | 1 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Week 20 | Mature adipose tissue | 15 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Week 20 | Fibrosis/scarring | 14 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Week 20 | Hemorrhage | 6 participants |
| Deoxycholic Acid 4% | Number of Participants With Positive Histopathology Results at Week 20 | Chronic inflammation | 13 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Week 20 | Hemorrhage | 2 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Week 20 | Necrosis | 3 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Week 20 | Chronic inflammation | 0 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Week 20 | Fibrosis/scarring | 6 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Week 20 | Mature adipose tissue | 16 participants |
| Placebo | Number of Participants With Positive Histopathology Results at Week 20 | Acute inflammation | 0 participants |
Secondary
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with \> 1 target lipoma, the total area of all target lipomas was used in the calculation of response.
Time frame: Baseline and week 20 (8 weeks after last dose)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 1% | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | ≥ 75% Cleared | 13.3 percentage of participants |
| Deoxycholic Acid 1% | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Complete Clearance | 0.0 percentage of participants |
| Deoxycholic Acid 2% | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Complete Clearance | 0.0 percentage of participants |
| Deoxycholic Acid 2% | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | ≥ 75% Cleared | 6.7 percentage of participants |
| Deoxycholic Acid 4% | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Complete Clearance | 7.1 percentage of participants |
| Deoxycholic Acid 4% | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | ≥ 75% Cleared | 14.3 percentage of participants |
| Placebo | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Complete Clearance | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | ≥ 75% Cleared | 11.8 percentage of participants |
Comparison: Complete Clearance95% CI: [-18.4, 20.4]
Comparison: Complete Clearance95% CI: [-18.4, 20.4]
Comparison: Complete Clearance95% CI: [-12.2, 31.5]
Comparison: ≥ 75% Cleared95% CI: [-23, 27.5]
Comparison: ≥ 75% Cleared95% CI: [-28.3, 19.6]
Comparison: ≥ 75% Cleared95% CI: [-22.3, 29.5]
Secondary
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area \* 100. A positive change indicates a reduction in size.
Time frame: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 1% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 12 | 41.2 percent change | Standard Deviation 31.5 |
| Deoxycholic Acid 1% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 20 | 50.1 percent change | Standard Deviation 30.6 |
| Deoxycholic Acid 1% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 16 | 43.9 percent change | Standard Deviation 30.1 |
| Deoxycholic Acid 2% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 12 | 28.5 percent change | Standard Deviation 46 |
| Deoxycholic Acid 2% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 20 | 25.9 percent change | Standard Deviation 42.6 |
| Deoxycholic Acid 2% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 16 | 23.3 percent change | Standard Deviation 41.8 |
| Deoxycholic Acid 4% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 16 | 20.0 percent change | Standard Deviation 38.2 |
| Deoxycholic Acid 4% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 12 | 18.0 percent change | Standard Deviation 34.9 |
| Deoxycholic Acid 4% | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 20 | 35.9 percent change | Standard Deviation 40.7 |
| Placebo | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 12 | 38.5 percent change | Standard Deviation 32.4 |
| Placebo | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 20 | 36.7 percent change | Standard Deviation 38 |
| Placebo | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Week 16 | 32.1 percent change | Standard Deviation 40.5 |