Efficacy and Safety Study of Combination Therapy to Treat Uncomplicated Obesity

April 18, 2008 updated by: Orexigen Therapeutics, Inc

Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study of Combination Therapy for Safety and Efficacy in Subjects With Uncomplicated Obesity

The purpose of this study is to determine the efficacy and safety of 3 combinations of naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A completed proof of concept study, OT-101 (Data on File, Orexigen Therapeutics, 2005), demonstrated that a combination of 300 mg bupropion SR and 50 mg naltrexone was associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity.

The hypothesis for the current trial is that by adjusting the doses and titration schedules of bupropion SR and naltrexone greater efficacy and improved tolerability can be achieved. In this trial, a higher dose of bupropion and 2 lower doses of naltrexone than utilized in the previous trial (OT-101) will be evaluated. The doses of both drugs will be titrated over 4 weeks and administered twice a day. There are 2 cohorts. At each site, cohort 2 recruitment began as soon as cohort 1 enrollment was completed. Cohort 1 treatment groups are (60 per group):

  • Group 1: Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day)
  • Group 2: Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day)
  • Group 3: Bupropion SR (400 mg/day) plus N-Placebo
  • Group 4: B-placebo plus Naltrexone (48 mg/day)
  • Group 5: B-Placebo plus N-Placebo

Cohort treatment 2 Groups are:

  • Group 6: B-Placebo plus N-Placebo (n=20)
  • Group 7: Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day)(n=60)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92130
        • Scripps Clinic Del Mar
    • Georgia
      • Augusta, Georgia, United States, 30909
        • CSRA Partners in Health, Inc
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • UK Clinical Research Organization
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Center for Nutrition and Preventive Medicine
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Weight Management Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female and male subjects, 18 to 60 years of age
  • Have body mass index (BMI) of 30 to 40 kg/m2
  • Free from clinically significant illness or disease as determined by medical history and physical examination
  • Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to baseline
  • Normotensive (systolic <140 mm Hg; diastolic <90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers, beta-blockers and clonidine. Medical regimen must be stable for at least 6 weeks
  • LDL cholesterol < 190 mg/dL and triglycerides < 400 mg/dL. Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks
  • No clinically significant abnormality of serum albumin, blood urea nitrogen, creatinine, calcium and phosphorus
  • Bilirubin, ALT and AST within 1.5 x ULN
  • No clinically significant abnormality of hematocrit, white blood cell count, white cell differential, or platelets
  • Fasting glucose less than 140 mg/dL on no hypoglycemic agents
  • No clinically significant abnormality on urinalysis
  • TSH within 1.5 x ULN, normal T3, if TSH below lower limit of normal
  • Negative serum pregnancy test in women with intact uterus
  • Score < 11 for depression and score < 11 for anxiety on Hospital Anxiety and Depression (HAD) Scale
  • ECG: no clinically significant abnormality
  • Score of zero on the Mood Assessment questionnaire and a response of "No" to the Bipolar Disorder Questions
  • If female with child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drugs
  • Able to comply with all required study procedures and schedule
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
  • Serious medical condition or medical condition that limits participation in the prescribed exercise program: (e.g. unstable cardiovascular disease including congestive heart failure, angina pectoris, and myocardial infarction; stroke; claudication; acute limb ischemia; acute renal or hepatic disorder; renal, hepatic or respiratory insufficiency)
  • Active malignancy or history of malignancy (other than non-melanoma skin cancer or surgically cured cervical cancer) within 5 years of enrollment
  • Serious psychiatric condition (e.g., any history of bipolar disorder, psychosis, suicidal attempt or post-partum depression; a history of major depression, suicidal ideation or antidepressant use within 1 year)
  • Type I or Type II diabetes mellitus requiring pharmacotherapy
  • Excluded concomitant medications: anorectic agents; weight loss agents; dietary supplements to promote muscle building, enhance mood, or reduce appetite; adrenergic blockers; beta blockers; anti-psychotic agents; clonidine; theophylline; cimetidine; oral corticosteroids; anti-depressant; topiramate; Depo-Provera®, smoking cessation agents; frequent, known use of opioid or opioid-like analgesics
  • History of surgical intervention for obesity
  • History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, significant head trauma, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
  • History of bulimia or anorexia nervosa
  • History of drug or alcohol abuse within 5 years
  • History of treatment with bupropion, or naltrexone within 12 months
  • History of hypersensitivity to bupropion, or naltrexone
  • Use of drugs, herbs, or dietary supplements known to significantly affect body weight within one month of baseline
  • Use of investigational drug, device or procedure within 90 days
  • Participation in any previous clinical trial conducted by Orexigen Therapeutics
  • Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day)
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Experimental: 2
Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day)
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Active Comparator: 3
Bupropion SR (400 mg/day)
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Active Comparator: 4
Naltrexone (48 mg/day)
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Placebo Comparator: 5
B-Placebo plus N-Placebo
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Placebo Comparator: 6
B-Placebo plus N-Placebo
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Experimental: 7
Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day)
Drug: naltrexone and bupropion SR
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage change in total body weight
Time Frame: baseline to week 24
baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orexigen Therapeutics, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frank Greenway, MD, Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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