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Trial Outcomes & Findings for Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat (NCT NCT02035267)

NCT ID: NCT02035267

Last Updated: 2020-02-17

Results Overview

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

93 participants

Primary outcome timeframe

Baseline and up to Week 32 (12 weeks after last treatment)

Results posted on

2020-02-17

Participant Flow

There were 61 subjects in the ATX-101 group and 32 subjects in the placebo group, who were further stratified by baseline Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (grade 1 included 31 ATX-101 and 16 placebo subjects; grade 4 included 30 ATX-101 and 16 placebo subjects).

Participant milestones

Participant milestones
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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
31
16
30
16
Overall Study
COMPLETED
31
15
28
15
Overall Study
NOT COMPLETED
0
1
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Overall Study
Withdrawal consent-subject convenience
0
0
1
0
Overall Study
Adverse Event
0
0
1
0
Overall Study
Lost to Follow-up
0
0
0
1
Overall Study
Other unspecified
0
1
0
0

Baseline Characteristics

Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=16 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=30 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=16 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Total
n=93 Participants
Total of all reporting groups
Age, Continuous
48.6 years
STANDARD_DEVIATION 9.68 • n=99 Participants
48.4 years
STANDARD_DEVIATION 8.75 • n=107 Participants
52.1 years
STANDARD_DEVIATION 7.94 • n=206 Participants
50.1 years
STANDARD_DEVIATION 11.21 • n=7 Participants
50.0 years
STANDARD_DEVIATION 9.27 • n=31 Participants
Age, Customized
18-30 years
3 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
5 Participants
n=31 Participants
Age, Customized
31-40 years
1 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
2 Participants
n=7 Participants
9 Participants
n=31 Participants
Age, Customized
41-50 years
16 Participants
n=99 Participants
6 Participants
n=107 Participants
10 Participants
n=206 Participants
5 Participants
n=7 Participants
37 Participants
n=31 Participants
Age, Customized
51-65+ years
11 Participants
n=99 Participants
7 Participants
n=107 Participants
16 Participants
n=206 Participants
8 Participants
n=7 Participants
42 Participants
n=31 Participants
Sex: Female, Male
Female
29 Participants
n=99 Participants
16 Participants
n=107 Participants
25 Participants
n=206 Participants
8 Participants
n=7 Participants
78 Participants
n=31 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
0 Participants
n=107 Participants
5 Participants
n=206 Participants
8 Participants
n=7 Participants
15 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=99 Participants
3 Participants
n=107 Participants
10 Participants
n=206 Participants
6 Participants
n=7 Participants
26 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=99 Participants
13 Participants
n=107 Participants
20 Participants
n=206 Participants
10 Participants
n=7 Participants
67 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
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
Race (NIH/OMB)
American Indian or Alaska Native
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
Race (NIH/OMB)
Asian
2 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
3 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
1 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=99 Participants
3 Participants
n=107 Participants
3 Participants
n=206 Participants
1 Participants
n=7 Participants
10 Participants
n=31 Participants
Race (NIH/OMB)
White
26 Participants
n=99 Participants
12 Participants
n=107 Participants
27 Participants
n=206 Participants
14 Participants
n=7 Participants
79 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
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
Race (NIH/OMB)
Unknown or Not Reported
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
Fitzpatrick skin type
I
2 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
2 Participants
n=31 Participants
Fitzpatrick skin type
II
1 Participants
n=99 Participants
2 Participants
n=107 Participants
9 Participants
n=206 Participants
5 Participants
n=7 Participants
17 Participants
n=31 Participants
Fitzpatrick skin type
III
12 Participants
n=99 Participants
6 Participants
n=107 Participants
6 Participants
n=206 Participants
4 Participants
n=7 Participants
28 Participants
n=31 Participants
Fitzpatrick skin type
IV
13 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
3 Participants
n=7 Participants
30 Participants
n=31 Participants
Fitzpatrick skin type
V
3 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
4 Participants
n=7 Participants
12 Participants
n=31 Participants
Fitzpatrick skin type
VI
0 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
0 Participants
n=7 Participants
4 Participants
n=31 Participants
Weight
68.22 kg
STANDARD_DEVIATION 12.935 • n=99 Participants
67.76 kg
STANDARD_DEVIATION 9.858 • n=107 Participants
87.51 kg
STANDARD_DEVIATION 12.009 • n=206 Participants
92.23 kg
STANDARD_DEVIATION 17.518 • n=7 Participants
78.49 kg
STANDARD_DEVIATION 16.759 • n=31 Participants
Body Mass Index (BMI)
24.60 kg/m^2
STANDARD_DEVIATION 4.529 • n=99 Participants
24.96 kg/m^2
STANDARD_DEVIATION 2.928 • n=107 Participants
32.46 kg/m^2
STANDARD_DEVIATION 3.898 • n=206 Participants
31.83 kg/m^2
STANDARD_DEVIATION 4.649 • n=7 Participants
28.44 kg/m^2
STANDARD_DEVIATION 5.547 • n=31 Participants
BMI category
30 kg/m^2 or less
29 Participants
n=99 Participants
15 Participants
n=107 Participants
9 Participants
n=206 Participants
6 Participants
n=7 Participants
59 Participants
n=31 Participants
BMI category
Greater than 30 kg/m^2
2 Participants
n=99 Participants
1 Participants
n=107 Participants
21 Participants
n=206 Participants
10 Participants
n=7 Participants
34 Participants
n=31 Participants
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
1
15 Participants
n=99 Participants
6 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
21 Participants
n=31 Participants
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
2
13 Participants
n=99 Participants
10 Participants
n=107 Participants
5 Participants
n=206 Participants
2 Participants
n=7 Participants
30 Participants
n=31 Participants
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
3
2 Participants
n=99 Participants
0 Participants
n=107 Participants
17 Participants
n=206 Participants
8 Participants
n=7 Participants
27 Participants
n=31 Participants
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
4
1 Participants
n=99 Participants
0 Participants
n=107 Participants
8 Participants
n=206 Participants
6 Participants
n=7 Participants
15 Participants
n=31 Participants
Submental Skin Laxity Grade (SMSLG)
None/mild
26 Participants
n=99 Participants
14 Participants
n=107 Participants
20 Participants
n=206 Participants
12 Participants
n=7 Participants
72 Participants
n=31 Participants
Submental Skin Laxity Grade (SMSLG)
Moderate/severe
5 Participants
n=99 Participants
2 Participants
n=107 Participants
10 Participants
n=206 Participants
4 Participants
n=7 Participants
21 Participants
n=31 Participants

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
61.3 percentage of participants
6.7 percentage of participants
89.3 percentage of participants
13.3 percentage of participants

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
42.9 percentage of participants
0 percentage of participants
—
—

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.

The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
74.2 percentage of participants
20.0 percentage of participants
96.4 percentage of participants
26.7 percentage of participants

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.

The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
71.4 percentage of participants
13.3 percentage of participants
—
—

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.

The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
67.7 percentage of participants
33.3 percentage of participants
89.3 percentage of participants
46.7 percentage of participants

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade = 4 were included, since a 2-grade improvement was not anticipated for baseline CR-SMFRS grade = 1 subjects.

The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
60.7 percentage of participants
20.0 percentage of participants
—
—

PRIMARY outcome

Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)

Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.

The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.

Outcome measures

Outcome measures
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=28 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=15 Participants
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 Submental Skin Laxity Grade Scale (SMSLG)
-0.3 scores on a scale
Standard Deviation 0.60
-0.1 scores on a scale
Standard Deviation 0.35
-0.3 scores on a scale
Standard Deviation 0.55
-0.2 scores on a scale
Standard Deviation 0.56

Adverse Events

ATX-101 (Deoxycholic Acid) Injection - Grade 1

Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths

Placebo Injection - Grade 1

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

ATX-101 (Deoxycholic Acid) Injection - Grade 4

Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths

Placebo Injection - Grade 4

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=16 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=30 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=16 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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
3.2%
1/31 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
0.00%
0/29 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
4.0%
1/25 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/8 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.

Other adverse events

Other adverse events
Measure
ATX-101 (Deoxycholic Acid) Injection - Grade 1
n=31 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 1
n=16 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
ATX-101 (Deoxycholic Acid) Injection - Grade 4
n=30 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Placebo Injection - Grade 4
n=16 participants at risk
Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) 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 pain
74.2%
23/31 • Number of events 82 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
50.0%
8/16 • Number of events 16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
53.3%
16/30 • Number of events 78 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
31.2%
5/16 • Number of events 19 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site bruising
48.4%
15/31 • Number of events 35 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
50.0%
8/16 • Number of events 14 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
60.0%
18/30 • Number of events 35 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
56.2%
9/16 • Number of events 16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site anaesthesia
48.4%
15/31 • Number of events 16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
53.3%
16/30 • Number of events 22 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site oedema
41.9%
13/31 • Number of events 34 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
25.0%
4/16 • Number of events 17 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
46.7%
14/30 • Number of events 37 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
18.8%
3/16 • Number of events 11 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site swelling
41.9%
13/31 • Number of events 20 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
12.5%
2/16 • Number of events 7 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
46.7%
14/30 • Number of events 25 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
12.5%
2/16 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site nodule
12.9%
4/31 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
13.3%
4/30 • Number of events 6 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site pruritus
12.9%
4/31 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
10.0%
3/30 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
12.5%
2/16 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site induration
12.9%
4/31 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
10.0%
3/30 • Number of events 3 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site erythema
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
10.0%
3/30 • Number of events 3 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Nervous system disorders
Headache
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 3 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
10.0%
3/30 • Number of events 6 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Skin and subcutaneous tissue disorders
Skin tightness
9.7%
3/31 • Number of events 5 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
13.3%
4/30 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site paraesthesia
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
12.5%
2/16 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site discolouration
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
3.3%
1/30 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site inflammation
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
3.3%
1/30 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
General disorders
Injection site warmth
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Nervous system disorders
Facial paresis
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Nasopharyngitis
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Folliculitis
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.7%
2/30 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Influenza
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
3.3%
1/30 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Tooth abscess
3.2%
1/31 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Gastroenteritis
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Herpes zoster
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Sinusitis
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Infections and infestations
Vulvovaginal candidiasis
0.00%
0/29 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/25 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
12.5%
1/8 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Skin and subcutaneous tissue disorders
Cutis laxa
9.7%
3/31 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 3 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Gastrointestinal disorders
Vomiting
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Gastrointestinal disorders
Abdominal pain
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Gastrointestinal disorders
Dental caries
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Gastrointestinal disorders
Toothache
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Psychiatric disorders
Anxiety
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
3.2%
1/31 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Metabolism and nutrition disorders
Hypercholesterolaemia
3.2%
1/31 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Vascular disorders
Hypertension
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.7%
2/30 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
6.5%
2/31 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/31 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
0.00%
0/30 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
6.2%
1/16 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.

Additional Information

Beta Bowen

Allergan, Inc

Phone: 1-714-246-4446

Results disclosure agreements

  • Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
  • Publication restrictions are in place

Restriction type: OTHER