Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects

Completed · Phase 3

Conditions studied: Obesity, Overweight

In brief

The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

Key facts

Study ID

NCT01764386

Run by

Orexigen Therapeutics, Inc

People needed

242

Starts

2013-02-01

Expected to finish

2014-09-01

Last updated by the study team

2015-12-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male, 18 to 60 years old
• Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity, or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled hypertension

You may not qualify if…

• History of type 1 or type 2 diabetes mellitus diagnosis
• Myocardial infarction within 6 months prior to screening
• Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
• Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)
• History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures
• Past or planned surgical or device intervention (e.g., gastric banding) for obesity
• Chronic use or positive screen for opioids
• Regular use of tobacco products

Where it is running

• Radiant Research — Denver, Colorado, United States
• Radiant Research, Inc. — St Louis, Missouri, United States
• PMG Research of Raleigh — Cary, North Carolina, United States
• PMG Research of Winston-Salem — Hickory, North Carolina, United States
• PMG Research of Raleigh — Raleigh, North Carolina, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Radiant Research-Akron — Akron, Ohio, United States
• Radiant Research, Inc. — Columbus, Ohio, United States
• Radiant Research — Anderson, South Carolina, United States
• Radiant Research, Greer — Greer, South Carolina, United States
• PMG Research of Charleston — Mt. Pleasant, South Carolina, United States
• PMG Research of Bristol — Bristol, Tennessee, United States
• Radiant Research Dallas-North — Dallas, Texas, United States
• Radiant Research, SLC — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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