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ObesityPhase 3NCT01764386

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

A Phase 3 study testing NB and CLI in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Overweight
What is being tested?
NB and CLI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
15 sitesUnited States
Study dates
Feb 2013to Sep 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Radiant Research-Akron

    Akron, Ohio, 44311

  • Radiant Research

    Anderson, South Carolina, 29621

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • PMG Research of Raleigh

    Cary, North Carolina, 27518

  • Radiant Research, Inc.

    Columbus, Ohio, 43212

  • Radiant Research Dallas-North

    Dallas, Texas, 75231

  • Radiant Research

    Denver, Colorado, 80239

  • Radiant Research, Greer

    Greer, South Carolina, 29651

  • PMG Research of Winston-Salem

    Hickory, North Carolina, 28601

  • PMG Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Radiant Research, SLC

    Salt Lake City, Utah, 84107

  • Radiant Research, Inc.

    St Louis, Missouri, 63151

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Open-Label, Controlled, 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 (The Ignite Study)

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).

Conditions
Obesity, Overweight
Being tested
NB, CLI, Usual Care
Keywords
obesity, overweight
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBDrug

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

  • CLIBehavioural

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

  • Usual CareBehavioural

    Usual Care is a self-directed lifestyle intervention program

Study groups in NCT01764386
Study groupRoleWhat they receive
NB + CLIExperimentalNaltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)
Receives: Drug: NB; Behavioral: CLI
Usual CareOtherUsual 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.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to Week 26

Secondary outcomes (17)

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

    Measured: Baseline to Week 26

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

    Measured: Baseline to Week 26

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

    Measured: Baseline to Week 26

  4. Absolute Change in Body Weight From Baseline to Week 26

    Measured: Baseline to Week 26

  5. Change in Waist Circumference From Baseline to Week 26

    Measured: Baseline to Week 26

  6. Change in Fasting Triglycerides From Baseline to Week 26

    Measured: Baseline to Week 26

  7. Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26

    Measured: Baseline to Week 26

  8. Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26

    Measured: Baseline to Week 26

  9. Change in Systolic Blood Pressure From Baseline to Week 26

    Measured: Baseline to Week 26

  10. Change in Diastolic Blood Pressure From Baseline to Week 26

    Measured: Baseline to Week 26

  11. Change in Heart Rate From Baseline to Week 26

    Measured: Baseline to Week 26

  12. Change in Fasting Plasma Glucose From Baseline to Week 26

    Measured: Baseline to Week 26

  13. Change Fasting Insulin From Baseline to Week 26

    Measured: Baseline to Week 26

  14. Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26

    HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.

    Measured: Baseline to Week 26

  15. Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26

    The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.

    Measured: Baseline to Week 26

  16. Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26

    Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.

    Measured: Baseline to Week 26

  17. Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26

    Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764386
Sponsor's protocol ID
NB-404
Status last verified
Nov 2015
First submitted
4 Jan 2013
Last updated
29 Dec 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 28026920

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NB and CLI in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Weight From Baseline (Day 1) to Week 26 (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764386, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.

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