Trial Outcomes & Findings for Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 (NCT NCT02483533)

NCT ID: NCT02483533

Last Updated: 2019-12-10

Results Overview

Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2019-12-10

Participant Flow

Participant milestones

Measure	Experimental: LIPO-202 Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. LIPO-202	Placebo Comparator: Placebo Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. Placebo
Overall Study STARTED	50	50
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	50	50

Reasons for withdrawal

Measure	Experimental: LIPO-202 Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. LIPO-202	Placebo Comparator: Placebo Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. Placebo
Overall Study Lack of Efficacy	50	50

Baseline Characteristics

Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202

Baseline characteristics by cohort

Measure	Experimental: LIPO-202 n=50 Participants Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. LIPO-202	Placebo Comparator: Placebo n=50 Participants Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. Placebo	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Lack of efficacy - not completed. Study was conducted by Neothetics Inc. and during a company merger with Evofem, no study data was provided. All efforts to locate this data have been exhausted, there is no longer access to this data to be reported.

Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Year

Population: Lack of efficacy - not completed. Study was conducted by Neothetics Inc. and during a company merger with Evofem, no study data was provided. All efforts to locate this data have been exhausted, there is no longer access to this data to be reported.

Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: LIPO-202

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Neothetics

Phone: 8585501900

Results disclosure agreements

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