Clinical Trials Logo
  1. Home
  2. Submental Fat
  3. NCT03005717

Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat

Submental Fat Clinical Trial

Official title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat

Clinical Trial Summary

Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS]) will be recruited for this study.

Clinical Trial Description

Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs).

The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03005717
Study type Interventional
Source Neothetics, Inc
Contact
Status Completed
Phase Phase 2
Start date December 22, 2016
Completion date June 2, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT05476679 - Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events Phase 1/Phase 2
Completed NCT04144049 - A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat Phase 2
Active, not recruiting NCT05154955 - A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat Phase 2
Completed NCT04258761 - A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin") Phase 2
Completed NCT05763160 - An Open-label Study That Will Test a Second Treatment Session of RZL-012. Phase 2
Completed NCT03946592 - Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat Phase 3
Completed NCT04867434 - Efficacy and Safety of RZL-012 on Submental Fat Reduction Phase 2
Completed NCT05466448 - An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects. Phase 1/Phase 2
Completed NCT04086823 - A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers. Phase 2
Completed NCT02159729 - Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 Phase 2
Completed NCT05195112 - Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat Phase 3
Completed NCT02163902 - Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 Phase 3
Completed NCT05476094 - Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects Phase 1