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

High Point Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: HPP404

Study type: Interventional

Funder types: Industry

Identifiers

NCT01540864

HPP404-201

Details and patient eligibility

About

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

Enrollment: 126 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 3 patient groups, including a placebo group

HPP404 35 mg

Experimental group

Treatment:

Drug: HPP404

HPP404 50 mg

Experimental group

Treatment:

Drug: HPP404

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo