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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01540864
• Other study ID #: HPP404-201
• Status: Terminated
• Phase: Phase 2
• First received: February 23, 2012
• Last updated: August 19, 2015
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2015
• Source: High Point Pharmaceuticals, LLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• HPP404
Administered orally once daily for 26 weeks
• Placebo
Administered orally once daily for 26 weeks

Locations

Country	Name	City	State
United States	Site 11	Augusta	Georgia
United States	Site 1	Charlotte	North Carolina
United States	Site 5	High Point	North Carolina
United States	Site 9	Hyannis	Massachusetts
United States	Site 12	Louisville	Kentucky
United States	Site 2	New York	New York
United States	Site 7	Norfolk	Virginia
United States	Site 6	Richmond	Virginia
United States	Site 10	Saint Paul	Minnesota
United States	Site 3	Valparaiso	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
High Point Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight loss		Day 1 to Day 182	No
Secondary	Number of subjects attaining a 5% or more weight loss		Day 1 to Day 182	No
Secondary	Absolute and percent change in Body Mass Index (BMI)		Day 1 to Day 182	No