ObesityPhase 4NCT04399395
Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery
A Phase 4 study testing Naltrexone/bupropion and Lifestyle in people with Obesity, run by Oslo University Hospital.
Trial summary
Limited/poor weight loss and weight regain are concerns following bariatric surgery, and weight regain may increase the risk for relapse of comorbidities related to obesity. Medications for weight reduction may assist further weight loss, and support weight maintenance, with positive effects on comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Naltrexone/bupropion and Lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 31 Dec 2022
- 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
- Men and women aged 18-65 years who have undergone RYGB, mini-RYGB or sleeve gastrectomy 2 or more years previously and either
- Have a percent total weight loss from time of surgery of <20% OR
- Have a regain of at least 5% or more of nadir weight (lowest weight at 12-18 months after surgery) AND
- Meet current clinical criteria for use of Mysimba (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with obesity-related comorbidity (diabetes type 2, controlled hypertension, dyslipidemia)
Who cannot join
- Serious illness or complications due to bariatric surgery according to the judgement of the investigators and clinical records
- Use of any weight loss medications following bariatric surgery
- Pregnancy or breastfeeding
- Participation in other weight loss studies
- Contraindication for use of Mysimba. These include but are not limited to epilepsy or history of seizure, uncontrolled hypertension (blood pressure ≥150/95 mmHg with or without medication), previous or current eating disorder, substance abuse, bipolar depression, serious liver or kidney disease, use of certain medications)
About this study
Official title: Treatment With Naltrexone/Buprpion (Mysimba) to Optimize Weight Outcomes After Bariatric Surgery
Limited/poor weight loss and weight regain are concerns following bariatric surgery, and weight regain may increase the risk for relapse of comorbidities related to obesity. Medications for weight reduction may assist further weight loss, and support weight maintenance, with positive effects on comorbidities. This pilot study will examine the effect of naltrexone/bupropion and lifestyle advice versus lifestyle advice alone for 7 months in patients with a suboptimal weight trajectory (either little weight loss or weight regain) 2 years or later following bariatric surgery.
Read the detailed description
Study aim and endpoints The aim of this pilot study is to evaluate the effect of Mysimba in patients with suboptimal weight loss or weight regain after bariatric surgery. The primary endpoint is body weight.
Objective The study objective is to understand whether patients with suboptimal weight loss or weight regain 2 years or more following bariatric surgery achieve better weight loss with Mysimba and dietary counselling compared with a control group treated with dietary counselling alone.
This is a phase IV, open label randomized controlled study conducted over 7 months with a 3-month post-intervention follow-up. The study will be conducted in accordance with good clinical practice. Patients meeting eligibility criteria will be randomized into one of two groups: an intervention group treated with Mysimba and lifestyle and a control group treated with lifestyle. The intervention group will be prescribed Mysimba gradually titrated to the maximum tolerated dose (maximum dose is 32 mg/360 mg divided in 4 tablets) with 2 week intervals. Both groups will receive the same follow up including dietary counselling during the course of the study. Randomization will be done using a standard internet-based program where group assignment cannot be anticipated. The study is not blinded.
- Conditions
- Obesity
- Being tested
- Naltrexone/bupropion, Lifestyle
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone/bupropionDrug
Approved drug for obesity treatment
LifestyleOther
Lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle and naltrexone/bupropion | Active comparator | Not described Receives: Drug: Naltrexone/bupropion; Other: Lifestyle |
| Lifestyle | Other | Not described Receives: Other: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Nov 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Covid-pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orexigen Therapeutics, Inc
- Responsible party
- Principal investigator, Serena Tonstad, Oslo University Hospital
- Investigators
- Serena Tonstad, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399395
- Sponsor's protocol ID
- 32772
- Status last verified
- Feb 2021
- First submitted
- 19 May 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Naltrexone/Buprpion (Mysimba) to Optimize Weight Outcomes After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04399395
- Acronym / sponsor ID
- 32772
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Orexigen Therapeutics, Inc
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 May 2020 (actual)
- 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.
Limited/poor weight loss and weight regain are concerns following bariatric surgery, and weight regain may increase the risk for relapse of comorbidities related to obesity. Medications for weight reduction may assist further weight loss, and support weight maintenance, with positive effects on comorbidities. This pilot study will examine the effect of naltrexone/bupropion and lifestyle advice versus lifestyle advice alone for 7 months in patients with a suboptimal weight trajectory (either little weight loss or weight regain) 2 years or later following bariatric surgery.
Detailed description
Study aim and endpoints The aim of this pilot study is to evaluate the effect of Mysimba in patients with suboptimal weight loss or weight regain after bariatric surgery. The primary endpoint is body weight.
Objective The study objective is to understand whether patients with suboptimal weight loss or weight regain 2 years or more following bariatric surgery achieve better weight loss with Mysimba and dietary counselling compared with a control group treated with dietary counselling alone.
This is a phase IV, open label randomized controlled study conducted over 7 months with a 3-month post-intervention follow-up. The study will be conducted in accordance with good clinical practice. Patients meeting eligibility criteria will be randomized into one of two groups: an intervention group treated with Mysimba and lifestyle and a control group treated with lifestyle. The intervention group will be prescribed Mysimba gradually titrated to the maximum tolerated dose (maximum dose is 32 mg/360 mg divided in 4 tablets) with 2 week intervals. Both groups will receive the same follow up including dietary counselling during the course of the study. Randomization will be done using a standard internet-based program where group assignment cannot be anticipated. The study is not blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle and naltrexone/bupropion | Active comparator | Drug: Naltrexone/bupropion, Other: Lifestyle |
| Lifestyle | Other | Other: Lifestyle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18-65 years who have undergone RYGB, mini-RYGB or sleeve gastrectomy 2 or more years previously and either
- Have a percent total weight loss from time of surgery of <20% OR
- Have a regain of at least 5% or more of nadir weight (lowest weight at 12-18 months after surgery) AND
- Meet current clinical criteria for use of Mysimba (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with obesity-related comorbidity (diabetes type 2, controlled hypertension, dyslipidemia)
Key exclusion criteria (5 listed)
- Serious illness or complications due to bariatric surgery according to the judgement of the investigators and clinical records
- Use of any weight loss medications following bariatric surgery
- Pregnancy or breastfeeding
- Participation in other weight loss studies
- Contraindication for use of Mysimba. These include but are not limited to epilepsy or history of seizure, uncontrolled hypertension (blood pressure ≥150/95 mmHg with or without medication), previous or current eating disorder, substance abuse, bipolar depression, serious liver or kidney disease, use of certain medications)
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/bupropionApproved drug for obesity treatment | Drug | Lifestyle and naltrexone/bupropion |
| LifestyleLifestyle | Other | Lifestyle, Lifestyle and naltrexone/bupropion |
Primary outcome
Body weight
Time frame: 7 months
Body weight
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 1 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Serena Tonstad, MD PhD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone/bupropion and Lifestyle in people with Obesity, run by Oslo University Hospital.
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 4 inclusion and 5 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Body weight (time frame: 7 months). 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 1 Mar 2021.