Dose Ranging and Dose Frequency of LIPO-102
Overview
Dose Ranging and Dose Frequency of LIPO-102
Full Title of Study: “A Dose-Ranging and Dose Frequency Study Evaluating the Safety and Efficacy of LIPO-102 for the Reduction of Abdominal Subcutaneous Adipose Tissue”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: February 2010
Interventions
- Drug: LIPO-102
- Subcutaneous Injection
- Drug: Placebo
- Placebo
Arms, Groups and Cohorts
- Experimental: LIPO-102
- LIPO-102
- Experimental: Placebo
- Placebo
Clinical Trial Outcome Measures
Primary Measures
- Safety: physical examinations, laboratory tests, AE assessment
- Time Frame: 4 weeks treatment and 4 weeks follow up
Secondary Measures
- Efficacy: change in subcutaneous abdominal adipose tissue thickness
- Time Frame: 4 weeks treatment and 4 weeks follow up
Participating in This Clinical Trial
Inclusion Criteria
- Male or non pregnant female – Good general health – Sufficient abdominal fat for injections – Signed informed consent Exclusion Criteria:
- Known hypersensitivity to study drugs – Treatment with an investigational agent within 30 days of first dose
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Neothetics, Inc
- Provider of Information About this Clinical Study
- Sponsor
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