Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysim… (NCT06098079) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
United States8,600 participantsStarted 2024-01-03
Plain-language summary
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient age ≥18 years at screening
. Able to understand the key components of the study, as described in the written informed consent document, and willing and able to provide written informed consent
. BMI ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbidity (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
. At increased risk of adverse cardiovascular outcomes:
. Patients who have completed a washout (2-weeks or 5 half-lives, whichever is longer) of the prohibited concomitant medication(s) at screening
. Subject willing to comply with daily completion of an eDiary using a mobile smartphone application
Exclusion criteria
. Using prescription medications, other than Contrave/Mysimba, or surgical or medical device interventions for weight loss
. History of MI or stroke within 90 days prior to screening
. Uncontrolled hypertension, defined as systolic BP ≥160 mmHg and/or \>100 mmHg diastolic BP on the average of 3 seated BP measurements after the patient has been at rest for at least 5 minutes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically tracking serious cardiovascular events like heart attack, stroke, and cardiovascular death, should I be concerned about my own heart health before considering this medication — and does my current cardiovascular risk profile matter for whether Contrave is appropriate for me?
2This is a Phase 4 trial, meaning the drug is already approved but being studied further for long-term heart safety — does that mean there are still open questions about cardiovascular risk with Contrave that I should know about before starting it?
3The trial is active but no longer enrolling new participants, so I can't join it — but based on what you know about this ongoing cardiovascular safety study, would you feel comfortable prescribing Contrave to me right now, or would you rather wait for the results?
4Are there other obesity treatments — either medications or non-drug approaches — where the cardiovascular safety profile is already more established, and would one of those be a better starting point for my situation?
5Given that this trial is measuring real-world outcomes like heart attack and stroke, what warning signs should I watch for if I were to start Contrave, and how would we monitor my cardiovascular health while I'm on it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Cardiovascular Death
Timeframe: Treatment initiation through 1 year following treatment termination.
2
Occurrence of Non-fatal Myocardial Infarction (MI)
Timeframe: Treatment initiation through 1 year following treatment termination.
3
Occurrence of Non-fatal Stroke
Timeframe: Treatment initiation through 1 year following treatment termination.
. Seizure disorders or history of seizures, not including subjects with a history of pediatric febrile seizures
. Use of other bupropion-containing products (including but not limited to Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin)
. Active anorexia nervosa or bulimia
. Chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opioid withdrawal or has a positive urine drug result for opioids at screening