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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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

Key facts

Study ID

NCT01540864

Run by

High Point Pharmaceuticals, LLC.

People needed

126

Starts

2012-05-01

Expected to finish

2013-05-01

Last updated by the study team

2015-09-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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