Back to resultsA Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
Primary Purpose
Obesity, Overweight
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HPP404
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Body Mass Index
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
Sites / Locations
- Site 11
- Site 3
- Site 12
- Site 9
- Site 10
- Site 2
- Site 1
- Site 5
- Site 7
- Site 6
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
HPP404 35 mg
HPP404 50 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percent weight loss
Secondary Outcome Measures
Number of subjects attaining a 5% or more weight loss
Absolute and percent change in Body Mass Index (BMI)
Full Information
NCT ID
NCT01540864
First Posted
February 23, 2012
Last Updated
August 19, 2015
Sponsor
High Point Pharmaceuticals, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT01540864
Brief Title
A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
High Point Pharmaceuticals, LLC.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Obesity, Overweight, Body Mass Index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPP404 35 mg
Arm Type
Experimental
Arm Title
HPP404 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HPP404
Intervention Description
Administered orally once daily for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally once daily for 26 weeks
Primary Outcome Measure Information:
Title
Percent weight loss
Time Frame
Day 1 to Day 182
Secondary Outcome Measure Information:
Title
Number of subjects attaining a 5% or more weight loss
Time Frame
Day 1 to Day 182
Title
Absolute and percent change in Body Mass Index (BMI)
Time Frame
Day 1 to Day 182
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrikas Vainorius, M.D.
Organizational Affiliation
High Point Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Site 11
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Site 3
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Site 12
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Site 9
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Site 10
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Site 2
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Site 1
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Site 5
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Site 7
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Site 6
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
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A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
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