Weight Regain Post Bariatric SurgeryPhase 4NCT02616315
Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Participants Post Bariatric Surgery
A Phase 4 study testing Naltrexone HCl/Bupropion HCl in people with Weight Regain Post Bariatric Surgery, run by Takeda at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Regain Post Bariatric Surgery
- What is being tested?
- Naltrexone HCl/Bupropion HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is female or male and aged 18 to 65 years, inclusive.
- Is at least 2 years post Roux-en-Y Gastric Bypass (RYGB) procedure for treatment of severe obesity prior to screening.
- Has achieved an initial weight loss of ≥20% of their preoperative body weight, and has regained ≥10% of the total weight lost.
- Has a body mass index (BMI) (weight [kg]/[height {m}]^2) ≥30 kg/m^2.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after the last dose of study drug.
- Is able to speak and read English.
Who cannot join
- Has obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome) or of genetic origin.
- Is currently using other bupropion- or naltrexone-containing products or has a history of hypersensitivity or allergies to naltrexone or bupropion.
- Has a history of cancer that has been in remission for <5 years prior to screening. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed.
- Has a history of Type 1 or current type 2 diabetes mellitus (T2DM) diagnosis.
- Has had a myocardial infarction within 6 months prior to screening.
- Has a history of Class III or IV congestive heart failure, as per the New York Heart Association functional classification.
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- Has a history of angina pectoris Grade III or IV, as per the Canadian Cardiovascular Society grading scheme.
- Has a clinical history of strokes, including ischemic and hemorrhagic strokes.
- Has a history (within the last 20 years) of seizures, cranial trauma, active bulimia, anorexia nervosa, or other conditions that predispose the participant to seizures.
- Has, in the judgment of the investigator, any clinically significant electrocardiogram (ECG), laboratory, hematology, physical examination, medical history, or urinalysis finding that should prohibit participation in the study.
- Has uncontrolled hypertension defined as blood pressure (BP) ≥145/95 mm Hg at screening. BP will be measured on 2 separate occasions with an approximate 30-minute interval between measurements at the screening visit.
- Has a thyrotropin (thyroid stimulating hormone -TSH) value outside the normal range at the screening visit; unless there is a normal triiodothyronine (T3) value.
- Had initiation or alteration of dose of antihypertensive or lipid-lowering agents within 4 weeks prior to screening.
- Used prescribed or over-the-counter drugs intended for weight loss, or participated in a weight loss program other than standard of care for a post bariatric population, within 3 months prior to randomization.
- Has prior or planned surgical or device intervention for obesity except for the required RYGB Surgery.
- Has a history or current diagnosis of angle-closure glaucoma.
- Is experiencing post bariatric dumping syndrome that may impact the conduct or outcome of the study as determined by the investigator.
- Has moderate or severe renal impairment (end-stage renal disease) defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2, using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI).
- Has a clinical history of hepatic impairment or current documented aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) at the screening visit.
- Has glycosylated hemoglobin (HbA1c) ≥6.5% at Screening Visit.
- Has current known infection with human immunodeficiency virus (HIV) or hepatitis (documentation of no detectable virus is required for participants with a past infection of hepatitis B or C).
- Is undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
- Is a chronic user or has a positive screen for opioids.
- Has a hemoglobin of ≤10 g/100 mL at the screening visit.
- Has a history of serious psychiatric illness such as:
- A Patient Health Questionnaire (PHQ)-9 score ≥10 at the screening visit.
- Bipolar disorder.
- Schizophrenia.
- Severe personality disorder (eg, borderline or antisocial).
- Major depressive disorder.
- Recent (previous 6 months) suicide attempt.
- Other psychosis.
- If female, the participant is pregnant or trying to become pregnant, currently breast-feeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) and not willing to practice birth control from signing of informed consent throughout the duration of the study and for 12 weeks after the last dose of study drug.
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has received Contrave in a previous clinical study or as a therapeutic agent.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Is required to take excluded medications.
- Participant is enrolled in any other interventional study at the time of Screening and during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
About this study
Official title: A Randomized, Double-Blind, Phase 4 Study to Evaluate the Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Patients Post Bariatric Surgery
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.
Read the detailed description
The drug being tested in this study is called naltrexone hydrochloride/bupropion hydrochloride (NB). NB is being tested to determine its effect on weight loss in obese participants post bariatric surgery.
The study will enroll approximately 60 participants. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Naltrexone HCl 32 mg/bupropion HCl 360 mg extended-release tablet
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
All participants will start on 1 tablet a day and will increase their dose by 1 tablet per week for 4 weeks to reach the optimal dose.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 59 weeks maximum. Participants will make multiple visits to the clinic, plus a final visit 4 weeks after last dose of study drug for a follow-up assessment.
- Conditions
- Weight Regain Post Bariatric Surgery
- Being tested
- Naltrexone HCl/Bupropion HCl Placebo, Naltrexone HCl/Bupropion HCl
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HCl/Bupropion HCl PlaceboDrug
Naltrexone/bupropion placebo-matching tablets
Naltrexone HCl/Bupropion HClDrug
Naltrexone HCl 8 mg/bupropion HCl 90 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Group A: Placebo | Placebo comparator | Naltrexone hydrochloride (HCl)/bupropion hydrochloride (HCl) placebo-matching tablet, orally, 1 tablet in the AM, daily, during Week 1, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 1 tablet in the AM and 1 in the PM, during Week 2, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 2 tablets in the AM and 1 in the PM, during Week 3, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 2 tablets in the AM and 2 in the PM, in Week 4 through Week 49. Participants must be re-titrated if off treatment for ≥1 week (≥7 days). Receives: Drug: Naltrexone HCl/Bupropion HCl Placebo |
| Group B: Naltrexone HCl/Bupropion HCl | Experimental | Naltrexone HCl 8 mg/bupropion HCl 90 mg, tablet, orally, 1 tablet in the AM, daily, during Week 1, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 1 tablet in the AM and 1 in the PM, during Week 2, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 2 tablets in the AM and 1 in the PM, during Week 3, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 2 tablets in the AM and 2 in the PM, in Week 4 through Week 49. Participants must be re-titrated if off treatment for ≥1 week (≥7 days). Receives: Drug: Naltrexone HCl/Bupropion HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight at Week 26
Measured: Baseline and Week 26
Secondary outcomes (7)
Percent Change from Baseline in Body Weight at Week 52
Measured: Baseline and Week 52
Percentage of Participants Achieving a Loss of at Least 2%, 5%, or 10% of Baseline Body Weight at Weeks 26 and 52
Measured: Baseline and Weeks 26 and 52
Changes from Baseline on Obesity-Associated Cardiovascular Risk Factors at Weeks 26 and 52
Obesity-associated cardiovascular risk factors, including serum triglycerides, high density lipoprotein (HDL), and low density lipoprotein (LDL) cholesterol, and waist circumference.
Measured: Baseline and Weeks 26 and 52
Change from Baseline in Fasting Glucose Levels at Weeks 26 and 52
Measured: Baseline and Weeks 26 and 52
Change from Baseline in and Glycosylated Hemoglobin (HbA1c) Levels at Weeks 26 and 52
Measured: Baseline and Weeks 26 and 52
Change from Baseline in Vital Signs at Weeks 26 and 52
Vital signs include systolic and diastolic blood pressure [BP] and heart rate.
Measured: Baseline and Weeks 26 and 52
Change from Baseline in Quality of Life as Measured by the Impact of Weight on Quality of Life Questionnaire - Lite Version (IWQOL-Lite) at Weeks 26 and 52
The IWQOL-Lite, is a validated 31-item, self -reported, obesity-specific measure of health-related quality of life that consists of a total score and scores on each of 5 scales (physical function, self-esteem, sexual life, public distress, and work) that exhibits strong psychometric properties. Participants rate items within the scales as: 5=always true, 4=usually true, 3=sometimes true, 2=rarely true, or 1=never true. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life.
Measured: Baseline and Weeks 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Regain Post Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director US Medical Affairs, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616315
- Sponsor's protocol ID
- NaltrexBuprop-4004
- Other IDs
- U1111-1168-9817
- Status last verified
- Apr 2016
- First submitted
- 24 Nov 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 4 Study to Evaluate the Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Patients Post Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02616315
- Acronym / sponsor ID
- NaltrexBuprop-4004
- Conditions
- Weight Regain Post Bariatric Surgery
- Keywords
- Drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.
Detailed description
The drug being tested in this study is called naltrexone hydrochloride/bupropion hydrochloride (NB). NB is being tested to determine its effect on weight loss in obese participants post bariatric surgery.
The study will enroll approximately 60 participants. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Naltrexone HCl 32 mg/bupropion HCl 360 mg extended-release tablet
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
All participants will start on 1 tablet a day and will increase their dose by 1 tablet per week for 4 weeks to reach the optimal dose.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 59 weeks maximum. Participants will make multiple visits to the clinic, plus a final visit 4 weeks after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Placebo | Placebo comparator | Drug: Naltrexone HCl/Bupropion HCl PlaceboNaltrexone hydrochloride (HCl)/bupropion hydrochloride (HCl) placebo-matching tablet, orally, 1 tablet in the AM, daily, during Week 1, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 1 tablet in the AM and 1 in the PM, during Week 2, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 2 tablets in the AM and 1 in the PM, during Week 3, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 2 tablets in the AM and 2 in the PM, in Week 4 through Week 49. Participants must be re-titrated if off treatment for ≥1 week (≥7 days). |
| Group B: Naltrexone HCl/Bupropion HCl | Experimental | Drug: Naltrexone HCl/Bupropion HClNaltrexone HCl 8 mg/bupropion HCl 90 mg, tablet, orally, 1 tablet in the AM, daily, during Week 1, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 1 tablet in the AM and 1 in the PM, during Week 2, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 2 tablets in the AM and 1 in the PM, during Week 3, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 2 tablets in the AM and 2 in the PM, in Week 4 through Week 49. Participants must be re-titrated if off treatment for ≥1 week (≥7 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is female or male and aged 18 to 65 years, inclusive.
- Is at least 2 years post Roux-en-Y Gastric Bypass (RYGB) procedure for treatment of severe obesity prior to screening.
- Has achieved an initial weight loss of ≥20% of their preoperative body weight, and has regained ≥10% of the total weight lost.
Key exclusion criteria (38 listed)
- Has obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome) or of genetic origin.
- Is currently using other bupropion- or naltrexone-containing products or has a history of hypersensitivity or allergies to naltrexone or bupropion.
- Has a history of cancer that has been in remission for <5 years prior to screening. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed.
- Has a history of Type 1 or current type 2 diabetes mellitus (T2DM) diagnosis.
- Has had a myocardial infarction within 6 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone HCl/Bupropion HCl PlaceboNaltrexone/bupropion placebo-matching tablets | Drug | Group A: Placebo |
| Naltrexone HCl/Bupropion HClNaltrexone HCl 8 mg/bupropion HCl 90 mg tablets | Drug | Group B: Naltrexone HCl/Bupropion HCl |
Primary outcome
Percent Change from Baseline in Body Weight at Week 26
Time frame: Baseline and Week 26
7 secondary outcomes
Percent Change from Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
Percentage of Participants Achieving a Loss of at Least 2%, 5%, or 10% of Baseline Body Weight at Weeks 26 and 52
Time frame: Baseline and Weeks 26 and 52
Changes from Baseline on Obesity-Associated Cardiovascular Risk Factors at Weeks 26 and 52
Time frame: Baseline and Weeks 26 and 52
Change from Baseline in Fasting Glucose Levels at Weeks 26 and 52
Time frame: Baseline and Weeks 26 and 52
Change from Baseline in and Glycosylated Hemoglobin (HbA1c) Levels at Weeks 26 and 52
Time frame: Baseline and Weeks 26 and 52
Change from Baseline in Vital Signs at Weeks 26 and 52
Time frame: Baseline and Weeks 26 and 52
Change from Baseline in Quality of Life as Measured by the Impact of Weight on Quality of Life Questionnaire - Lite Version (IWQOL-Lite) at Weeks 26 and 52
Time frame: Baseline and Weeks 26 and 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director US Medical Affairs study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone HCl/Bupropion HCl in people with Weight Regain Post Bariatric Surgery, run by Takeda at 2 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 8 inclusion and 38 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: withdrawn, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from Baseline in Body Weight at Week 26 (time frame: Baseline and Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2016.