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Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR1)

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ClinicalTrials.gov Identifier: NCT02397499
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Neothetics, Inc

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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
Study Start Date : April 2015
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Salmeterol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests. [ Time Frame: 8 weeks ]
    Physical examination, adverse events, vital signs, and laboratory tests.

  2. Change in the clinician reported photonumeric score [ Time Frame: 8 weeks post the start of treatment ]
  3. Change in the patient reported global abdominal perception score [ Time Frame: 8 weeks post the start of treatment ]

Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: 8 weeks post the start of treatment ]

Eligibility Criteria
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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:   No
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
Contacts and Locations
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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): NCT02397499


Locations
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Sponsors and Collaborators
Neothetics, Inc
Investigators
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Study Director: Maria Feldman Neothetics, Inc
More Information
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Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT02397499    
Other Study ID Numbers: LIPO-202-CL-18
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
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