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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01540864
First received: February 23, 2012
Last updated: August 29, 2012
Last verified: August 2012

February 23, 2012
August 29, 2012
May 2012
September 2012   (final data collection date for primary outcome measure)
Percent weight loss [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
Absolute and percent change in body weight [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01540864 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Absolute change in waist circumference [ Designated as safety issue: No ]
  • Number of Participant Adverse Events [ Designated as safety issue: No ]
  • Absolute and percent change in Body Mass Index (BMI) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Drug: HPP404
    Administered orally once daily for 26 weeks
  • Drug: Placebo
    Administered orally once daily for 26 weeks
  • Experimental: HPP404 35 mg
    Intervention: Drug: HPP404
  • Experimental: HPP404 50 mg
    Intervention: Drug: HPP404
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
114
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01540864
HPP404-201
No
High Point Pharmaceuticals, LLC.
High Point Pharmaceuticals, LLC.
Not Provided
Study Director: Enrikas Vainorius, M.D. High Point Pharmaceuticals, LLC.
High Point Pharmaceuticals, LLC.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP