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

• Sponsor: High Point Pharmaceuticals, LLC. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01540864
• Collaborator: (none)
• Enrollment: 126
• Locations: 10
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 12.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight	Drug: HPP404; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Percent weight loss [Day 1 to Day 182]

Secondary Outcome Measures

1. Number of subjects attaining a 5% or more weight loss [Day 1 to Day 182]

2. Absolute and percent change in Body Mass Index (BMI) [Day 1 to Day 182]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Site 11	Augusta	Georgia	United States	30909
2	Site 3	Valparaiso	Indiana	United States	46383
3	Site 12	Louisville	Kentucky	United States	40213
4	Site 9	Hyannis	Massachusetts	United States	02601
5	Site 10	Saint Paul	Minnesota	United States	55114
6	Site 2	New York	New York	United States	10065
7	Site 1	Charlotte	North Carolina	United States	28277
8	Site 5	High Point	North Carolina	United States	27265
9	Site 7	Norfolk	Virginia	United States	23502
10	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: High Point Pharmaceuticals, LLC.
• ClinicalTrials.gov Identifier: NCT01540864
• Other Study ID Numbers: HPP404-201
• First Posted: Feb 29, 2012
• Last Update Posted: Sep 4, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by High Point Pharmaceuticals, LLC.: Obesity; Overweight; Body Mass Index
• Additional relevant MeSH terms: Overweight; Weight Loss

Study Results

No Results Posted as of Sep 4, 2015