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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: High Point Pharmaceuticals, LLC.

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