Trial Outcomes & Findings for Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2) (NCT NCT02398188)
NCT ID: NCT02398188
Last Updated: 2019-01-07
Results Overview
The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment. Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from "Flat" to "Big Bulge". Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
793 participants
Primary outcome timeframe
Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)
Results posted on
2019-01-07
Participant Flow
Participant milestones
| Measure |
LIPO-202
Experimental arm
LIPO-202
|
Placebo
Placebo comparator
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
398
|
395
|
|
Overall Study
COMPLETED
|
371
|
361
|
|
Overall Study
NOT COMPLETED
|
27
|
34
|
Reasons for withdrawal
| Measure |
LIPO-202
Experimental arm
LIPO-202
|
Placebo
Placebo comparator
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Non-compliance
|
4
|
4
|
|
Overall Study
Protocol Violation
|
6
|
10
|
|
Overall Study
Sponsor Decision
|
2
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
16
|
Baseline Characteristics
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
Baseline characteristics by cohort
| Measure |
LIPO-202
n=398 Participants
Experimental arm
LIPO-202
|
Placebo
n=395 Participants
Placebo comparator
Placebo
|
Total
n=793 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
41 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
40 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
327 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
661 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
83 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
315 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
632 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
316 Participants
n=5 Participants
|
325 Participants
n=7 Participants
|
641 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
398 participants
n=5 Participants
|
395 participants
n=7 Participants
|
793 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)Population: ITT Population
The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment. Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from "Flat" to "Big Bulge". Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale.
Outcome measures
| Measure |
LIPO-202
n=368 Participants
Experimental arm
LIPO-202
|
Placebo
n=361 Participants
Placebo comparator
Placebo
|
|---|---|---|
|
Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
|
37 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post the start of treatment1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
Outcome measures
| Measure |
LIPO-202
n=398 Participants
Experimental arm
LIPO-202
|
Placebo
n=395 Participants
Placebo comparator
Placebo
|
|---|---|---|
|
Percent Change in the Patient Reported Global Abdominal Perception Score
|
202 percent change
Standard Deviation 51
|
175 percent change
Standard Deviation 44
|
SECONDARY outcome
Timeframe: 8 weeks post the start of treatmentOutcome measures
| Measure |
LIPO-202
n=398 Participants
Experimental arm
LIPO-202
|
Placebo
n=395 Participants
Placebo comparator
Placebo
|
|---|---|---|
|
Percent Change in Waist Circumference
|
24.1 percent change
Standard Deviation 2.65
|
24.2 percent change
Standard Deviation 2.66
|
Adverse Events
LIPO-202
Serious events: 1 serious events
Other events: 138 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LIPO-202
n=398 participants at risk
Experimental arm
LIPO-202
|
Placebo
n=395 participants at risk
Placebo comparator
Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
0.25%
1/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.25%
1/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
0.00%
0/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
Other adverse events
| Measure |
LIPO-202
n=398 participants at risk
Experimental arm
LIPO-202
|
Placebo
n=395 participants at risk
Placebo comparator
Placebo
|
|---|---|---|
|
General disorders
Injection Site Bruising
|
26.9%
107/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
27.8%
110/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
|
General disorders
Injection Site Haemorrhage
|
3.3%
13/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
3.3%
13/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
|
General disorders
Injection Site Pain
|
2.5%
10/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
3.8%
15/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
|
General disorders
Injection Site Erythema
|
1.0%
4/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
1.0%
4/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.0%
4/398 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
2.0%
8/395 • The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
|
Additional Information
Neothetics Clinical
Neothetics, Inc.
Phone: 858-550-1900
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER