Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).

Key facts

Study ID: NCT06098079
Run by: Currax Pharmaceuticals
People needed: 8600
Starts: 2024-01-03
Expected to finish: 2029-07-01
Last updated by the study team: 2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
In the opinion of the investigator, has a high likelihood of cardiovascular disease with at least 1 of the following:
History of documented MI >90 days prior to screening
History of coronary revascularization (ie, coronary artery bypass graft surgery, stent placement, percutaneous transluminal coronary angioplasty, or laser atherectomy) >90 days prior to screening
History of carotid or peripheral revascularization (ie, carotid endarterectomy, lower extremity atherosclerotic disease atherectomy, repair of abdominal aorta aneurysm, femoral or popliteal bypass) >90 days prior to screening
Angina with ischemic changes (resting echocardiogram (ECHO), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study)
Ankle brachial index <0.9 (by simple palpation) within prior 2 years or
Type 2 diabetes mellitus with at least 2 of the following:
Hypertension (controlled with or without pharmacotherapy at <145/95 mmHg)
Dyslipidemia requiring pharmacotherapy
Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within the prior 12 months
Current tobacco smoker
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

You may not qualify if…

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
Meets any of the following criteria:
Confirmed end-stage renal disease (ie, a degree of kidney failure severe enough to require dialysis or kidney transplantation for survival characterized by a severe reduction in glomerular filtration rate [<15 mL/minute/1.73 m2] and other manifestations including increased serum creatinine),
Severe hepatic impairment (Child-Pugh score 10 to 15 [Class C]),
Hemodynamic instability, including patients with severe heart failure (New York Heart Association Class IV)
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
Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
Concomitant administration of MAOIs. This also includes use of reversible MAOIs, such as linezolid or intravenous methylene blue. At least 14 days should elapse between discontinuation of MAOIs and initiation of treatment with Contrave/Mysimba.
Subject has any disease or condition, or use of any pharmacological agent to treat the disease/condition, that, in the opinion of the investigator, would contraindicate study participation
Known allergy to bupropion, naltrexone, or any other component of Contrave/Mysimba
Pregnant or nursing
Known life-threatening arrythmias, including Brugada syndrome
Participation in any other concurrent investigational trial

Where it is running

Accel Research Sites Network — Birmingham, Alabama, United States
Cullman Clinical Trials — Cullman, Alabama, United States
AMR Mobile — Mobile, Alabama, United States
Velocity Clinical Research, Mobile — Mobile, Alabama, United States
Sun City Research — Glendale, Arizona, United States
Cardiovascular Consultants/NextStage Clinical Research — Glendale, Arizona, United States
Desert Clinical Research — Mesa, Arizona, United States
Velocity Clinical Research, Phoenix — Phoenix, Arizona, United States
Fiel Family & Sports Medicine CCT Research — Tempe, Arizona, United States
Synexus Clinical Research US; Inc. — Tucson, Arizona, United States
Velocity Clinical Research, Gardena — Anderson, California, United States
Velocity Clinical Research — Chula Vista, California, United States
Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
Velocity Clinical Research, San Diego — La Mesa, California, United States
Chemidox Clinical Trials Inc. — Lancaster, California, United States
Long Beach Clinical Trials — Long Beach, California, United States
Velocity Clinical Research — Los Angeles, California, United States
Valley Vitality Ventures — Manteca, California, United States
National Institute of Clinical Research, Inc. — Pomona, California, United States
Velocity Clinical Research, San Bernardino — San Bernardino, California, United States
Velocity Clinical Research at Coastal Heart Medical Group — Santa Ana, California, United States
Velocity Clinical Research of Santa Ana — Santa Ana, California, United States
Velocity Clinical Research, Van Nuys — Van Nuys, California, United States
Providere Research — West Covina, California, United States
TrialMed Birmingham (DRS) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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