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 NCT01546142)

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

516 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

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	258	258
Overall Study Received Treatment	257	257
Overall Study COMPLETED	214	224
Overall Study NOT COMPLETED	44	34

Reasons for withdrawal

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Overall Study Consent Withdrawn (Subject Convenience)	15	15
Overall Study Subject Noncompliance	1	1
Overall Study Adverse Event	6	3
Overall Study Lost to Follow-up	20	15
Overall Study Consent Withdrawn (Subject Discomfort)	1	0
Overall Study Subject Randomized but Not Treated	1	0

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

Baseline characteristics by cohort
Measure	Deoxycholic Acid Injection n=258 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=258 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=516 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 9.30 • n=99 Participants	47.6 years STANDARD_DEVIATION 8.99 • n=107 Participants	47.9 years STANDARD_DEVIATION 9.14 • n=206 Participants
Age, Customized 18-50 years	149 participants n=99 Participants	150 participants n=107 Participants	299 participants n=206 Participants
Age, Customized 51-65 years	109 participants n=99 Participants	108 participants n=107 Participants	217 participants n=206 Participants
Sex: Female, Male Female	221 Participants n=99 Participants	224 Participants n=107 Participants	445 Participants n=206 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	34 Participants n=107 Participants	71 Participants n=206 Participants
Race/Ethnicity, Customized White	222 participants n=99 Participants	222 participants n=107 Participants	444 participants n=206 Participants
Race/Ethnicity, Customized Black or African American	24 participants n=99 Participants	21 participants n=107 Participants	45 participants n=206 Participants
Race/Ethnicity, Customized Asian	4 participants n=99 Participants	5 participants n=107 Participants	9 participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 participants n=99 Participants	2 participants n=107 Participants	3 participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	3 participants n=99 Participants	1 participants n=107 Participants	4 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	2 participants n=99 Participants	7 participants n=107 Participants	9 participants n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	40 participants n=99 Participants	39 participants n=107 Participants	79 participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	218 participants n=99 Participants	219 participants n=107 Participants	437 participants n=206 Participants
Weight	81.38 kg STANDARD_DEVIATION 14.791 • n=99 Participants	80.31 kg STANDARD_DEVIATION 15.041 • n=107 Participants	80.84 kg STANDARD_DEVIATION 14.912 • n=206 Participants
Body Mass Index (BMI)	29.22 kg/m² STANDARD_DEVIATION 4.755 • n=99 Participants	29.30 kg/m² STANDARD_DEVIATION 4.282 • n=107 Participants	29.26 kg/m² STANDARD_DEVIATION 4.520 • n=206 Participants
Fitzpatrick Skin Type I - III	170 participants n=99 Participants	176 participants n=107 Participants	346 participants n=206 Participants
Fitzpatrick Skin Type IV - VI	88 participants n=99 Participants	82 participants n=107 Participants	170 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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection n=258 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=258 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	66.5 percentage of participants	22.2 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

Outcome measures
Measure	Deoxycholic Acid Injection n=258 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=258 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	18.6 percentage of participants	3.0 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

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=112 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	40.2 percentage of participants	5.2 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

Outcome measures
Measure	Deoxycholic Acid Injection n=258 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=258 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)	-3.48 units on a scale Standard Deviation 2.692	-1.42 units on a scale Standard Deviation 2.453

Adverse Events

Deoxycholic Acid Injection

Serious events: 7 serious events

Other events: 251 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 216 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Disclosure

Kythera

Email: [email protected]

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

Measure	Deoxycholic Acid Injection n=258 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=256 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.
Infections and infestations Diverticulitis	0.00% 0/258 • 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.	0.39% 1/256 • 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 Influenza	0.00% 0/258 • 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.	0.39% 1/256 • 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 Spinal cord infection	0.00% 0/258 • 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.	0.39% 1/256 • 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 Urinary tract infection	0.39% 1/258 • 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% 0/256 • 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% 0/258 • 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.	0.39% 1/256 • 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 recurrent	0.39% 1/258 • 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% 0/256 • 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) Ovarian cancer	0.39% 1/258 • 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% 0/256 • 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) Uterine cancer	0.39% 1/258 • 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% 0/256 • 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) Uterine leiomyoma	0.39% 1/258 • 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% 0/256 • 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 surgery	0.00% 0/258 • 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.	0.39% 1/256 • 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 Intervertebral disc operation	0.39% 1/258 • 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% 0/256 • 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 Vaginal operation	0.00% 0/258 • 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.	0.39% 1/256 • 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	0.39% 1/258 • 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% 0/256 • 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 Pancreatitis	0.00% 0/258 • 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.	0.39% 1/256 • 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 Road traffic accident	0.39% 1/258 • 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% 0/256 • 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 Toxicity to various agents	0.00% 0/258 • 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.	0.39% 1/256 • 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 failure congestive	0.00% 0/258 • 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.	0.39% 1/256 • 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 Transient ischaemic attack	0.00% 0/258 • 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.	0.39% 1/256 • 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.
Reproductive system and breast disorders Cystocele	0.39% 1/258 • 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% 0/256 • 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.
Reproductive system and breast disorders Rectocele	0.39% 1/258 • 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% 0/256 • 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.
Reproductive system and breast disorders Uterine prolapse	0.39% 1/258 • 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% 0/256 • 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.

Measure	Deoxycholic Acid Injection n=258 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=256 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	72.9% 188/258 • 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.	72.7% 186/256 • 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	73.6% 190/258 • 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.	39.1% 100/256 • 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	67.8% 175/258 • 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.	36.3% 93/256 • 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	65.5% 169/258 • 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.	7.0% 18/256 • 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	35.3% 91/258 • 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.	25.4% 65/256 • 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	29.1% 75/258 • 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.	15.6% 40/256 • 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	28.3% 73/258 • 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.	3.5% 9/256 • 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	16.3% 42/258 • 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.	8.2% 21/256 • 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	14.7% 38/258 • 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.	4.3% 11/256 • 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	14.3% 37/258 • 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.	4.3% 11/256 • 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 warmth	5.8% 15/258 • 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.	2.3% 6/256 • 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 Upper respiratory tract infection	5.8% 15/258 • 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.	7.0% 18/256 • 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.
Skin and subcutaneous tissue disorders Skin tightness	7.4% 19/258 • 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.	2.0% 5/256 • 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	8.9% 23/258 • 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.	3.1% 8/256 • 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	4.7% 12/258 • 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.	5.1% 13/256 • 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.