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

August 19, 2015 updated by: High Point Pharmaceuticals, LLC.

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

The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Site 11
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Site 3
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Site 12
    • Massachusetts
      • Hyannis, Massachusetts, United States, 02601
        • Site 9
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Site 10
    • New York
      • New York, New York, United States, 10065
        • Site 2
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Site 1
      • High Point, North Carolina, United States, 27265
        • Site 5
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Site 7
      • Richmond, Virginia, United States, 23294
        • Site 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered orally once daily for 26 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent weight loss
Time Frame: Day 1 to Day 182
Day 1 to Day 182

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

High Point Pharmaceuticals, LLC.

Investigators

  • Study Director: Enrikas Vainorius, M.D., High Point Pharmaceuticals, LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

February 29, 2012

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPP404-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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