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An Open-Label Study to Evaluate Retreatment With LIPO-202

N

Neothetics

Status and phase

Unknown
Phase 2

Conditions

Central Abdominal Bulging

Treatments

Drug: LIPO-202

Study type

Interventional

Funder types

Industry

Identifiers

NCT02397525
LIPO-202-CL-22

Details and patient eligibility

About

Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provided consent
  • Healthy male or non-pregnant female subjects
  • BMI < 30 kg/m2
  • Stable diet and exercise routine
  • Central abdominal bulging that is 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.
  • Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
  • Known hypersensitivity to study drugs
  • Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

LIPO-202
Experimental group
Treatment:
Drug: LIPO-202

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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