Trial Outcomes & Findings for Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat (NCT NCT00618618)

Last Updated: 2015-07-14

Results Overview

The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

Results posted on

2015-07-14

Participant Flow

This study was conducted at 7 study centers: 4 in Canada, 2 in Australia and 1 in the United Kingdom.

Participants were randomized to receive either deoxycholic acid or placebo injection in one of 3 treatment dosing regimens for a total of 6 treatment groups. Placebo participants were pooled for analysis.

Participant milestones

Participant milestones
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.4 mL/1.0 cm Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Overall Study STARTED	24	14	21	14
Overall Study Received Treatment	24	13	20	14
Overall Study COMPLETED	20	11	18	13
Overall Study NOT COMPLETED	4	3	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.4 mL/1.0 cm Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Overall Study Patient Request	0	0	2	0
Overall Study Inability to Complete Study Procedures	0	1	0	0
Overall Study Lost to Follow-up	3	0	0	1
Overall Study Non-compliance	1	1	0	0
Overall Study Did Not Meet Entry Criteria	0	0	1	0
Overall Study Death	0	1	0	0

Baseline Characteristics

Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Total n=71 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 7.79 • n=99 Participants	45.9 years STANDARD_DEVIATION 4.23 • n=107 Participants	47.0 years STANDARD_DEVIATION 10.37 • n=206 Participants	49.4 years STANDARD_DEVIATION 10.85 • n=7 Participants	47.1 years STANDARD_DEVIATION 8.69 • n=31 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	11 Participants n=107 Participants	15 Participants n=206 Participants	10 Participants n=7 Participants	55 Participants n=31 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants	4 Participants n=7 Participants	16 Participants n=31 Participants
Race/Ethnicity, Customized White	24 participants n=99 Participants	13 participants n=107 Participants	20 participants n=206 Participants	14 participants n=7 Participants	71 participants n=31 Participants
Weight	78.31 kg STANDARD_DEVIATION 11.987 • n=99 Participants	82.10 kg STANDARD_DEVIATION 18.204 • n=107 Participants	90.80 kg STANDARD_DEVIATION 17.128 • n=206 Participants	84.78 kg STANDARD_DEVIATION 16.381 • n=7 Participants	83.78 kg STANDARD_DEVIATION 16.074 • n=31 Participants
Submental Fat (SMF) Rating 2	17 participants n=99 Participants	10 participants n=107 Participants	11 participants n=206 Participants	7 participants n=7 Participants	45 participants n=31 Participants
Submental Fat (SMF) Rating 3	7 participants n=99 Participants	3 participants n=107 Participants	9 participants n=206 Participants	7 participants n=7 Participants	26 participants n=31 Participants
Fitzpatrick Skin Type I - III	24 participants n=99 Participants	13 participants n=107 Participants	20 participants n=206 Participants	14 participants n=7 Participants	71 participants n=31 Participants
Fitzpatrick Skin Type IV - VI	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants	0 participants n=31 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

Population: Safety/miTT subset

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Number of Participants With Adverse Events Any adverse event	24 participants	13 participants	20 participants	14 participants
Number of Participants With Adverse Events Adverse event associated with treatment area	24 participants	13 participants	20 participants	14 participants
Number of Participants With Adverse Events Study drug-related adverse event	24 participants	13 participants	20 participants	14 participants
Number of Participants With Adverse Events Study drug-related severe adverse event	6 participants	0 participants	5 participants	0 participants
Number of Participants With Adverse Events Serious adverse event	0 participants	1 participants	0 participants	0 participants
Number of Participants With Adverse Events Discontinued due to adverse event	2 participants	1 participants	0 participants	0 participants
Number of Participants With Adverse Events Deaths	0 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

Population: Safety/mITT subset

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations Physical Examinations	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations Laboratory Values	3 participants	0 participants	2 participants	0 participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations Weight	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations Vital Signs	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

Population: Safety/mITT subset with available data

The SMF rating scale 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. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=22 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=10 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Change From Baseline in Submental Fat (SMF) Rating Scale Score	-1.0 units on a scale Standard Deviation 0.58	-1.2 units on a scale Standard Deviation 0.63	-0.8 units on a scale Standard Deviation 0.72	-0.4 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

Population: Safety/mITT subset with available data

The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=22 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=10 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Change From Baseline in Subject Satisfaction With Appearance Rating Scale	3.5 units on a scale Standard Deviation 1.47	4.3 units on a scale Standard Deviation 1.34	2.8 units on a scale Standard Deviation 2.20	1.8 units on a scale Standard Deviation 1.72

SECONDARY outcome

Timeframe: 4 weeks after last treatment (up to 16 weeks after first dose)

Population: Safety/mITT subset with available data

Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=22 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=10 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Percentage of Participants With a Response in the Subject Global Improvement Rating	95.5 percentage of participants	90.0 percentage of participants	80.0 percentage of participants	57.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

Population: Safety/mITT subset with available data

Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale 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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=22 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=10 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Percentage of Participants With an SMF Response	81.8 percentage of participants	90.0 percentage of participants	60.0 percentage of participants	35.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)

Population: Safety/mITT subset

Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Change From Baseline in Skin Laxity Rating Week 4	-0.1 units on a scale Standard Deviation 0.34	-0.1 units on a scale Standard Deviation 0.64	-0.2 units on a scale Standard Deviation 0.54	0.0 units on a scale Standard Deviation 0.78
Change From Baseline in Skin Laxity Rating Week 8	-0.2 units on a scale Standard Deviation 0.59	0.1 units on a scale Standard Deviation 0.30	-0.1 units on a scale Standard Deviation 0.57	-0.1 units on a scale Standard Deviation 0.66
Change From Baseline in Skin Laxity Rating Week 12	-0.1 units on a scale Standard Deviation 0.51	-0.2 units on a scale Standard Deviation 0.39	-0.2 units on a scale Standard Deviation 0.71	-0.1 units on a scale Standard Deviation 0.53
Change From Baseline in Skin Laxity Rating Week 16	-0.2 units on a scale Standard Deviation 0.60	-0.3 units on a scale Standard Deviation 0.48	-0.2 units on a scale Standard Deviation 0.59	-0.1 units on a scale Standard Deviation 0.53
Change From Baseline in Skin Laxity Rating Week 24	-0.2 units on a scale Standard Deviation 0.68	-0.4 units on a scale Standard Deviation 0.67	-0.1 units on a scale Standard Deviation 0.66	-0.2 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)

Population: Safety/mITT subset

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score Week 4	-0.3 units on a scale Standard Deviation 0.57	-0.5 units on a scale Standard Deviation 0.52	-0.1 units on a scale Standard Deviation 0.32	-0.3 units on a scale Standard Deviation 0.47
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score Week 8	-0.6 units on a scale Standard Deviation 0.67	-0.6 units on a scale Standard Deviation 0.67	-0.5 units on a scale Standard Deviation 0.61	-0.4 units on a scale Standard Deviation 0.50
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score Week 12	-0.9 units on a scale Standard Deviation 0.59	-1.0 units on a scale Standard Deviation 0.74	-0.7 units on a scale Standard Deviation 0.59	-0.4 units on a scale Standard Deviation 0.51
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score Week 16	-1.0 units on a scale Standard Deviation 0.58	-1.2 units on a scale Standard Deviation 0.63	-0.8 units on a scale Standard Deviation 0.72	-0.4 units on a scale Standard Deviation 0.50
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score Week 24	-1.0 units on a scale Standard Deviation 0.45	-1.2 units on a scale Standard Deviation 0.87	-1.0 units on a scale Standard Deviation 0.67	-0.4 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

Population: Safety/mITT subset with available data

The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=22 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=10 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=13 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Change From Baseline in the Cervicomental Angle	-5.0 degrees Standard Deviation 9.85	-1.5 degrees Standard Deviation 7.84	-1.5 degrees Standard Deviation 10.40	-2.7 degrees Standard Deviation 7.80

SECONDARY outcome

Timeframe: Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12

Population: Safety/mITT subset with available data at each time point (indicated by "N")

Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)

Outcome measures

Outcome measures
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 Participants Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	0Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 Participants Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 Participants Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Visual Analogue Scale Pain Intensity Rating Treatment 1 (N=24, 12, 20, 14)	33.0 units on a scale Standard Deviation 27.29	25.8 units on a scale Standard Deviation 16.19	41.9 units on a scale Standard Deviation 27.50	17.1 units on a scale Standard Deviation 19.03
Visual Analogue Scale Pain Intensity Rating Treatment 2 (N=19, 10, 16, 14)	27.9 units on a scale Standard Deviation 27.69	38.2 units on a scale Standard Deviation 26.62	31.1 units on a scale Standard Deviation 31.00	24.9 units on a scale Standard Deviation 28.73
Visual Analogue Scale Pain Intensity Rating Treatment 3 (N=17, 10, 16, 13)	26.5 units on a scale Standard Deviation 28.50	19.2 units on a scale Standard Deviation 25.35	22.6 units on a scale Standard Deviation 30.77	20.7 units on a scale Standard Deviation 27.21
Visual Analogue Scale Pain Intensity Rating Treatment 4 (N=14, 10, 15, 14)	14.0 units on a scale Standard Deviation 18.68	13.7 units on a scale Standard Deviation 14.55	19.0 units on a scale Standard Deviation 24.74	16.7 units on a scale Standard Deviation 27.27

Adverse Events

Deoxycholic Acid Injection 0.2 mL/0.7 cm

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Deoxycholic Acid Injection 0.2 mL/1.0 cm

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Deoxycholic Acid Injection 0.4 mL/1.0 cm

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Deoxycholic Acid Injection 0.2 mL/0.7 cm n=24 participants at risk Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.2 mL/1.0 cm n=13 participants at risk Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Deoxycholic Acid Injection 0.4 mL/1.0 cm n=20 participants at risk Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Pooled Placebo n=14 participants at risk Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Cardiac disorders Cardiac Arrest	0.00% 0/24 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).	7.7% 1/13 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).	0.00% 0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).	0.00% 0/14 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.00% 0/24 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).	7.7% 1/13 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).	0.00% 0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).	0.00% 0/14 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).

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