A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
This study is ongoing, but not recruiting participants.
Sponsor:
High Point Pharmaceuticals, LLC.
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01540864
First received: February 23, 2012
Last updated: August 29, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Overweight |
Drug: HPP404 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by High Point Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Percent weight loss [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of subjects attaining a 5% or more weight loss [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
- Absolute and percent change in Body Mass Index (BMI) [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
| Enrollment: | 114 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HPP404 35 mg |
Drug: HPP404
Administered orally once daily for 26 weeks
|
| Experimental: HPP404 50 mg |
Drug: HPP404
Administered orally once daily for 26 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Administered orally once daily for 26 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540864
Locations
| United States, Georgia | |
| Site 11 | |
| Augusta, Georgia, United States, 30909 | |
| United States, Indiana | |
| Site 3 | |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Kentucky | |
| Site 12 | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Massachusetts | |
| Site 9 | |
| Hyannis, Massachusetts, United States, 02601 | |
| United States, Minnesota | |
| Site 10 | |
| Saint Paul, Minnesota, United States, 55114 | |
| United States, New York | |
| Site 2 | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Site 1 | |
| Charlotte, North Carolina, United States, 28277 | |
| Site 5 | |
| High Point, North Carolina, United States, 27265 | |
| United States, Virginia | |
| Site 7 | |
| Norfolk, Virginia, United States, 23502 | |
| Site 6 | |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
High Point Pharmaceuticals, LLC.
Investigators
| Study Director: | Enrikas Vainorius, M.D. | High Point Pharmaceuticals, LLC. |
More Information
No publications provided
| Responsible Party: | High Point Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT01540864 History of Changes |
| Other Study ID Numbers: | HPP404-201 |
| Study First Received: | February 23, 2012 |
| Last Updated: | August 29, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by High Point Pharmaceuticals, LLC.:
|
Obesity Overweight Body Mass Index |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 16, 2013