NCT01764386

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 26, 2015

Completed
Last Updated

December 29, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

January 4, 2013

Results QC Date

September 7, 2015

Last Update Submit

November 30, 2015

Conditions

ObesityOverweight

Keywords

obesity, overweight

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Body Weight From Baseline (Day 1) to Week 26

    Baseline to Week 26

Secondary Outcomes (17)

  • Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26

    Baseline to Week 26

  • Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26

    Baseline to Week 26

  • Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26

    Baseline to Week 26

  • Absolute Change in Body Weight From Baseline to Week 26

    Baseline to Week 26

  • Change in Waist Circumference From Baseline to Week 26

    Baseline to Week 26

  • +12 more secondary outcomes

Study Arms (2)

NB + CLI

EXPERIMENTAL

Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)

Drug: NBBehavioral: CLI

Usual Care

OTHER

Usual Care (self-directed lifestyle intervention) Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.

Behavioral: Usual Care

Interventions

NBDRUG

Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)

NB + CLI
CLIBEHAVIORAL

The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.

NB + CLI
Usual CareBEHAVIORAL

Usual Care is a self-directed lifestyle intervention program

Usual Care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Radiant Research

Denver, Colorado, 80239, United States

Location

Radiant Research, Inc.

St Louis, Missouri, 63151, United States

Location

PMG Research of Raleigh

Cary, North Carolina, 27518, United States

Location

PMG Research of Winston-Salem

Hickory, North Carolina, 28601, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Radiant Research-Akron

Akron, Ohio, 44311, United States

Location

Radiant Research, Inc.

Columbus, Ohio, 43212, United States

Location

Radiant Research

Anderson, South Carolina, 29621, United States

Location

Radiant Research, Greer

Greer, South Carolina, 29651, United States

Location

PMG Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

Radiant Research Dallas-North

Dallas, Texas, 75231, United States

Location

Radiant Research, SLC

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

  • Halseth A, Shan K, Walsh B, Gilder K, Fujioka K. Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity. Obesity (Silver Spring). 2017 Feb;25(2):338-345. doi: 10.1002/oby.21726. Epub 2016 Dec 27.

    PMID: 28026920DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Executive Vice President, Head of Global Development
Organization
Orexigen Therapeutics, Inc.
MedInfo@Orexigen.com
(858) 875-8600

Study Officials

  • Senior Vice President, Head of Global Development

    Orexigen Therapeutics, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 9, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 29, 2015

Results First Posted

November 26, 2015

Record last verified: 2015-11

Locations

US(15)