Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)

Evofem

Status and phase: Completed; Phase 3

Conditions: Central Abdominal Bulging

Treatments: Drug: LIPO-202; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02398188

LIPO-202-CL-19

Details and patient eligibility

About

This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.

Enrollment: 793 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female subjects
• Capable of providing written consent.
• BMI < 30 kg/m2
• Stable diet and exercise routine
• Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat

Exclusion criteria

• Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
• Plan on starting a weight loss or exercise program during the study.
• Known hypersensitivity to study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

793 participants in 2 patient groups, including a placebo group

LIPO-202

Experimental group

Description:

Experimental arm

Treatment:

Drug: LIPO-202

Placebo

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Drug: Placebo