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
1 other identifier
interventional
126
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started May 2012
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedSeptember 4, 2015
August 1, 2015
1 year
February 23, 2012
August 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent weight loss
Day 1 to Day 182
Secondary Outcomes (2)
Number of subjects attaining a 5% or more weight loss
Day 1 to Day 182
Absolute and percent change in Body Mass Index (BMI)
Day 1 to Day 182
Study Arms (3)
HPP404 35 mg
EXPERIMENTALHPP404 50 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Site 11
Augusta, Georgia, 30909, United States
Site 3
Valparaiso, Indiana, 46383, United States
Site 12
Louisville, Kentucky, 40213, United States
Site 9
Hyannis, Massachusetts, 02601, United States
Site 10
Saint Paul, Minnesota, 55114, United States
Site 2
New York, New York, 10065, United States
Site 1
Charlotte, North Carolina, 28277, United States
Site 5
High Point, North Carolina, 27265, United States
Site 7
Norfolk, Virginia, 23502, United States
Site 6
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Enrikas Vainorius, M.D.
High Point Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 4, 2015
Record last verified: 2015-08