A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects

Phase 2

Terminated

• Conditions: Obesity; Overweight
• Interventions: Drug: HPP404; Drug: Placebo

• Registration Number: NCT01540864
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Study Start: 2012-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-08
• Disposition First Submitted: 2015-08-19
• Disposition First Submitted QC: 2015-08-19
• Last Update Submitted: 2015-08-19
• Disposition First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPP404 35 mg	HPP404	-
Placebo	Placebo	-
HPP404 50 mg	HPP404	-

Primary Outcome Measures

Name	Time	Method
Percent weight loss	Day 1 to Day 182

Secondary Outcome Measures

Name	Time	Method
Absolute and percent change in Body Mass Index (BMI)	Day 1 to Day 182
Number of subjects attaining a 5% or more weight loss	Day 1 to Day 182

Trial Locations

Locations (10)

Site 11; 🇺🇸 Augusta, Georgia, United States

Site 3; 🇺🇸 Valparaiso, Indiana, United States

Site 12; 🇺🇸 Louisville, Kentucky, United States

Site 9; 🇺🇸 Hyannis, Massachusetts, United States

Site 10; 🇺🇸 Saint Paul, Minnesota, United States

Site 2; 🇺🇸 New York, New York, United States

Site 1; 🇺🇸 Charlotte, North Carolina, United States

Site 5; 🇺🇸 High Point, North Carolina, United States

Site 7; 🇺🇸 Norfolk, Virginia, United States

Site 6; 🇺🇸 Richmond, Virginia, United States