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.

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.

Overall Status Terminated
Start Date May 2012
Completion Date May 2013
Primary Completion Date May 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent weight loss Day 1 to Day 182
Secondary Outcome
Measure Time Frame
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
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

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

Overall Official
Last Name Role Affiliation
Enrikas Vainorius, M.D. Study Director High Point Pharmaceuticals, LLC.
Location
Facility:
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
Location Countries

United States

Verification Date

August 2015

Responsible Party

Type: Sponsor

Keywords
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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov