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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398188
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Neothetics, Inc
Information provided by (Responsible Party):
Evofem Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Central Abdominal Bulging Drug: LIPO-202 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 793 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 9, 2015
Actual Primary Completion Date : October 29, 2015
Actual Study Completion Date : October 29, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Salmeterol

Arm Intervention/treatment
Experimental: LIPO-202
Experimental arm
Drug: LIPO-202
Other Name: Salmeterol

Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo
Other Name: Placebo for LIPO-202




Primary Outcome Measures :
  1. Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response [ Time Frame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment) ]

    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.


  2. Percent Change in the Patient Reported Global Abdominal Perception Score [ Time Frame: 8 weeks post the start of treatment ]
    1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.


Secondary Outcome Measures :
  1. Percent Change in Waist Circumference [ Time Frame: 8 weeks post the start of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398188


Locations
Show Show 35 study locations
Sponsors and Collaborators
Evofem Inc.
Neothetics, Inc
Investigators
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Study Director: Maria Feldman Neothetics, Inc
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Responsible Party: Evofem Inc.
ClinicalTrials.gov Identifier: NCT02398188    
Other Study ID Numbers: LIPO-202-CL-19
First Posted: March 25, 2015    Key Record Dates
Results First Posted: January 7, 2019
Last Update Posted: January 7, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action