NCT04054011

Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat

Completed EARLY_PHASE1 Results posted Last updated 20 January 2021

What this trial tests

EARLY_PHASE1 trial testing Deoxycholic Acid in Adiposity in 15 participants. Completed in 19 May 2020.

Timeline

5 July 2019

Primary endpoint
19 May 2020

19 May 2020

Quick facts

Lead sponsor	University of California, San Diego
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	5 July 2019
Primary completion	19 May 2020
Estimated completion	19 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Deoxycholic Acid (DEOXYCHOLIC ACID) — full drug profile →

Conditions studied

• Adiposity — all drugs for Adiposity →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 65, any sex, with Adiposity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · Baseline to 12 weeks after last treatment

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.

ransient subcutaneous nodules

Group	Value	95% CI
Deoxycholic Acid	08

injection-site urticaria

Group	Value	95% CI
Deoxycholic Acid	01

Temporary numbness

Group	Value	95% CI
Deoxycholic Acid	02

Thigh Circumference Change Primary · Baseline to 12 weeks after last treatment

change in thigh circumference as measured by tape measure

average change from baseline at 4 week

Group	Value	95% CI
Deoxycholic Acid	-1.8	± 0.5

average change from baseline at 12 week

Group	Value	95% CI
Deoxycholic Acid	-2.2	± 0.6

Upper Inner Thigh Skin Fold Thickness Change Primary · Baseline to 12 weeks after last treatment

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

average change from baselineat 4 week

Group	Value	95% CI
Deoxycholic Acid	-7.3	± 2.10

average change from baseline at 12 week

Group	Value	95% CI
Deoxycholic Acid	-8.8	± 2.53

Change in Thigh Gap Primary · 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.

Group	Value	95% CI
Deoxycholic Acid ?Placebo	1.6	± 0.8

Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs Secondary · 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

Group	Value	95% CI
Deoxycholic Acid	83

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected during the entire study duration (up to 12 weeks after last treatment, or up to 9 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Deoxycholic Acid

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (4 terms — click to expand)

Reaction	System	Deoxycholic Acid
pain	Skin and subcutaneous tissue disorders	—
swelling	Skin and subcutaneous tissue disorders	—
erythema	Skin and subcutaneous tissue disorders	—
bruising	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04054011 adverse events section.

Sponsor's own description

This is a phase I, open-label clinical trial evaluating the safety and efficacy of deoxycholic acid injection for reduction of upper inner thigh fat.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.