A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
A 26 Week Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Various Doses of HPP404 on Weight Loss in Overweight or Obese Subjects
| Sponsors |
Lead Sponsor: High Point Pharmaceuticals, LLC. |
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| Source | High Point Pharmaceuticals, LLC. | |||||||||||
| Brief Summary | The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects. |
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| Overall Status | Terminated | |||||||||||
| Start Date | May 2012 | |||||||||||
| Completion Date | May 2013 | |||||||||||
| Primary Completion Date | May 2013 | |||||||||||
| Phase | Phase 2 | |||||||||||
| Study Type | Interventional | |||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 126 | |||||||||||
| Condition | ||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: HPP404 Description: Administered orally once daily for 26 weeks Intervention Type: Drug Intervention Name: Placebo Description: Administered orally once daily for 26 weeks Arm Group Label: Placebo |
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| Eligibility |
Criteria:
Inclusion Criteria: - Body Mass Index (BMI) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities; - BMI from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high LDL (≥ 160 mg/dL) or high total cholesterol (≥ 240 mg/dL), or subjects with hypertension) Exclusion Criteria: - Systolic blood pressure > 160 mmHg and/or diastolic pressure > 90 mmHg at the Screening Visit without treatment - History of use of tobacco or nicotine-containing products 180 days prior to Screening visit - Subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dL - History of appetite or weight modifying surgeries/procedures Gender: All Minimum Age: 18 Years Maximum Age: 65 Years Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
August 2015 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | |||||||||||
| Condition Browse | ||||||||||||
| Number Of Arms | 3 | |||||||||||
| Arm Group |
Label: HPP404 35 mg Type: Experimental Label: HPP404 50 mg Type: Experimental Label: Placebo Type: Placebo Comparator |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Double (Participant, Investigator) |
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