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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01540864
First received: February 23, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Obesity
Overweight
Drug: HPP404
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by High Point Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Percent weight loss [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects attaining a 5% or more weight loss [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
  • Absolute and percent change in Body Mass Index (BMI) [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Administered orally once daily for 26 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540864

Locations
United States, Georgia
Site 11
Augusta, Georgia, United States, 30909
United States, Indiana
Site 3
Valparaiso, Indiana, United States, 46383
United States, Kentucky
Site 12
Louisville, Kentucky, United States, 40213
United States, Massachusetts
Site 9
Hyannis, Massachusetts, United States, 02601
United States, Minnesota
Site 10
Saint Paul, Minnesota, United States, 55114
United States, New York
Site 2
New York, New York, United States, 10065
United States, North Carolina
Site 1
Charlotte, North Carolina, United States, 28277
Site 5
High Point, North Carolina, United States, 27265
United States, Virginia
Site 7
Norfolk, Virginia, United States, 23502
Site 6
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
High Point Pharmaceuticals, LLC.
Investigators
Study Director: Enrikas Vainorius, M.D. High Point Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01540864     History of Changes
Other Study ID Numbers: HPP404-201
Study First Received: February 23, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by High Point Pharmaceuticals, LLC.:
Obesity
Overweight
Body Mass Index

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014