Trial Outcomes & Findings for Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (NCT NCT01542034)
NCT ID: NCT01542034
Last Updated: 2015-06-15
Results Overview
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
506 participants
Primary outcome timeframe
Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Results posted on
2015-06-15
Participant Flow
The study was performed at 35 investigational centers in the United States (US) and Canada.
Participant milestones
| Measure |
Deoxycholic Acid Injection
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
256
|
250
|
|
Overall Study
Received Treatment
|
256
|
249
|
|
Overall Study
COMPLETED
|
226
|
227
|
|
Overall Study
NOT COMPLETED
|
30
|
23
|
Reasons for withdrawal
| Measure |
Deoxycholic Acid Injection
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Overall Study
Consent Withdrawn (Subject Convenience)
|
20
|
12
|
|
Overall Study
Administrative decision
|
0
|
3
|
|
Overall Study
Subject Noncompliance
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
Baseline Characteristics
Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
Baseline characteristics by cohort
| Measure |
Deoxycholic Acid Injection
n=256 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=250 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 9.30 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 9.33 • n=107 Participants
|
49.5 years
STANDARD_DEVIATION 9.30 • n=206 Participants
|
|
Age, Customized
18 - 50 years
|
122 participants
n=99 Participants
|
121 participants
n=107 Participants
|
243 participants
n=206 Participants
|
|
Age, Customized
51 - 65 years
|
134 participants
n=99 Participants
|
129 participants
n=107 Participants
|
263 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
421 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
218 participants
n=99 Participants
|
227 participants
n=107 Participants
|
445 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 participants
n=99 Participants
|
13 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
28 participants
n=99 Participants
|
17 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
228 participants
n=99 Participants
|
233 participants
n=107 Participants
|
461 participants
n=206 Participants
|
|
Weight
|
81.15 kg
STANDARD_DEVIATION 14.549 • n=99 Participants
|
80.98 kg
STANDARD_DEVIATION 14.296 • n=107 Participants
|
81.07 kg
STANDARD_DEVIATION 14.411 • n=206 Participants
|
|
Body Mass Index (BMI)
|
29.23 kg/m²
STANDARD_DEVIATION 4.406 • n=99 Participants
|
29.26 kg/m²
STANDARD_DEVIATION 4.281 • n=107 Participants
|
29.25 kg/m²
STANDARD_DEVIATION 4.340 • n=206 Participants
|
|
Fitzpatrick Skin Type
I - III
|
180 participants
n=99 Participants
|
187 participants
n=107 Participants
|
367 participants
n=206 Participants
|
|
Fitzpatrick Skin Type
IV - VI
|
76 participants
n=99 Participants
|
63 participants
n=107 Participants
|
139 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Outcome measures
| Measure |
Deoxycholic Acid Injection
n=256 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=250 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Composite 1-grade Response
|
70.0 percentage of participants
|
18.6 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Intent-to-treat population; missing values were imputed using a multiple imputation process.
A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Outcome measures
| Measure |
Deoxycholic Acid Injection
n=256 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=250 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Composite 2-grade Response
|
13.4 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.
An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.
Outcome measures
| Measure |
Deoxycholic Acid Injection
n=113 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=111 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response
|
46.3 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Intent-to-treat population; missing values were imputed using a multiple imputation process.
The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Deoxycholic Acid Injection
n=256 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=250 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
|
-3.56 units on a scale
Standard Deviation 2.793
|
-1.16 units on a scale
Standard Deviation 2.064
|
Adverse Events
Deoxycholic Acid Injection
Serious events: 6 serious events
Other events: 246 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 196 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deoxycholic Acid Injection
n=257 participants at risk
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=248 participants at risk
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Infections and infestations
Abdominal abscess
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Nervous system disorders
Meningism
|
0.39%
1/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.00%
0/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.40%
1/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
Other adverse events
| Measure |
Deoxycholic Acid Injection
n=257 participants at risk
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=248 participants at risk
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
General disorders
Injection site haematoma
|
70.0%
180/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
67.3%
167/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site pain
|
65.4%
168/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
23.4%
58/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site oedema
|
52.9%
136/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
21.8%
54/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site anaesthesia
|
66.9%
172/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
4.4%
11/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site swelling
|
37.4%
96/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
15.7%
39/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site erythema
|
17.9%
46/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
10.1%
25/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site induration
|
18.3%
47/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
1.6%
4/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site paraesthesia
|
12.8%
33/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
3.2%
8/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site nodule
|
12.5%
32/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
0.81%
2/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
General disorders
Injection site pruritus
|
8.6%
22/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
3.6%
9/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
23/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
10.5%
26/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
|
Nervous system disorders
Headache
|
7.4%
19/257 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
4.4%
11/248 • From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.
- Publication restrictions are in place
Restriction type: OTHER