Trial Outcomes & Findings for Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat (NCT NCT04054011)

NCT ID: NCT04054011

Last Updated: 2021-01-20

Results Overview

1. Any adverse event (AE) ascertained by patient report or physician evaluation 2. One or more serious adverse events (SAE) as defined by CTCAEv4 3. Adverse events leading to study drug discontinuation.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline to 12 weeks after last treatment
• Results posted on: 2021-01-20

Participant Flow

No significant events pertaining to pre-assignment.

Participant milestones

Measure	Deoxycholic Acid Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.) Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Deoxycholic Acid Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.) Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous

Overall Study COVID

3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Deoxycholic Acid n=15 Participants Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.) Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants
Age, Continuous	35 years n=15 Participants
Sex: Female, Male Female	15 Participants n=15 Participants
Sex: Female, Male Male	0 Participants n=15 Participants
Region of Enrollment United States	15 Participants n=15 Participants
BMI	24 kg/m^2 n=15 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks after last treatment

Population: AE in number of participants

1. Any adverse event (AE) ascertained by patient report or physician evaluation

2. One or more serious adverse events (SAE) as defined by CTCAEv4

3. Adverse events leading to study drug discontinuation.

Outcome measures

Measure	Deoxycholic Acid n=12 Participants single arm study without comparison
Number of Participants With Adverse Events ransient subcutaneous nodules	08 participants
Number of Participants With Adverse Events injection-site urticaria	01 participants
Number of Participants With Adverse Events Temporary numbness	02 participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks after last treatment

change in thigh circumference as measured by tape measure

Outcome measures

Measure	Deoxycholic Acid n=12 Participants single arm study without comparison
Thigh Circumference Change average change from baseline at 4 week	-1.8 cm Standard Deviation 0.5
Thigh Circumference Change average change from baseline at 12 week	-2.2 cm Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline to 12 weeks after last treatment

change in upper inner thigh skin fold thickness as measured by body fat calipers

Outcome measures

Measure	Deoxycholic Acid n=12 Participants single arm study without comparison
Upper Inner Thigh Skin Fold Thickness Change average change from baselineat 4 week	-7.3 mm Standard Deviation 2.10
Upper Inner Thigh Skin Fold Thickness Change average change from baseline at 12 week	-8.8 mm Standard Deviation 2.53

PRIMARY outcome

Timeframe: 12 weeks

Thigh gap," measured with a handheld soft ruler, was defined as the horizontal distance between baseline "sites of maximum bulge," with feet at standardized distance apart.

Outcome measures

Measure	Deoxycholic Acid n=12 Participants single arm study without comparison
Change in Thigh Gap	1.6 centimeters Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 weeks

3 blinded physicians identified the before and after photos and the percentage number was 83% for percent accuracy of the results. The percent accuracy was calculated for the entire Arm/Group rather than for each participant

Outcome measures

Measure	Deoxycholic Acid n=12 Participants single arm study without comparison
Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs	83 percent accuracy of post treatment photo

Adverse Events

Deoxycholic Acid

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Deoxycholic Acid n=15 participants at risk Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.) Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
Skin and subcutaneous tissue disorders pain	100.0% 15/15 • Number of events 15 • Adverse events were collected during the entire study duration (up to 12 weeks after last treatment, or up to 9 months). Does not differ from clinicaltrials.gov. since this is a local treatment with minimal to no systemic affects, there is no risk of mortality to subjects. Subjects may experience adverse events described in the study description.
Skin and subcutaneous tissue disorders swelling	100.0% 15/15 • Number of events 15 • Adverse events were collected during the entire study duration (up to 12 weeks after last treatment, or up to 9 months). Does not differ from clinicaltrials.gov. since this is a local treatment with minimal to no systemic affects, there is no risk of mortality to subjects. Subjects may experience adverse events described in the study description.
Skin and subcutaneous tissue disorders erythema	100.0% 15/15 • Number of events 15 • Adverse events were collected during the entire study duration (up to 12 weeks after last treatment, or up to 9 months). Does not differ from clinicaltrials.gov. since this is a local treatment with minimal to no systemic affects, there is no risk of mortality to subjects. Subjects may experience adverse events described in the study description.
Skin and subcutaneous tissue disorders bruising	100.0% 15/15 • Number of events 15 • Adverse events were collected during the entire study duration (up to 12 weeks after last treatment, or up to 9 months). Does not differ from clinicaltrials.gov. since this is a local treatment with minimal to no systemic affects, there is no risk of mortality to subjects. Subjects may experience adverse events described in the study description.

Additional Information

Joyce Yuan, MD

UCSD Dermatology

Phone: (858) 657-8322

Email: joyce.yuan2@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place