Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
NCT ID: NCT06098079
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
8600 participants
INTERVENTIONAL
2024-01-03
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Naltrexone/Bupropion (NB)
Patients will be randomly assigned to NB (naltrexone 8 mg and bupropion 90 mg) extended-release oral tablet.
Naltrexone-Bupropion (NB) Combination
A total daily dosage of two NB 8 mg/90 mg tablets twice daily (32 mg/360 mg) is reached at the start of Week 4.
Placebo
Patients will be randomly assigned to placebo.
Placebo
A total daily dosage of two placebo tablets twice daily (in an identical, non-medicine containing tablet) is reached at the start of Week 4.
Interventions
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Naltrexone-Bupropion (NB) Combination
A total daily dosage of two NB 8 mg/90 mg tablets twice daily (32 mg/360 mg) is reached at the start of Week 4.
Placebo
A total daily dosage of two placebo tablets twice daily (in an identical, non-medicine containing tablet) is reached at the start of Week 4.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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)
4. 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
5. Patients who have completed a washout (2-weeks or 5 half-lives, whichever is longer) of the prohibited concomitant medication(s) at screening
6. Subject willing to comply with daily completion of an eDiary using a mobile smartphone application
Exclusion Criteria
2. History of MI or stroke within 90 days prior to screening
3. 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
4. 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)
5. Seizure disorders or history of seizures, not including subjects with a history of pediatric febrile seizures
6. Use of other bupropion-containing products (including but not limited to Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin)
7. Active anorexia nervosa or bulimia
8. 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
9. Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
10. 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.
11. 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
12. Known allergy to bupropion, naltrexone, or any other component of Contrave/Mysimba
13. Pregnant or nursing
14. Known life-threatening arrythmias, including Brugada syndrome
15. Participation in any other concurrent investigational trial
18 Years
ALL
No
Sponsors
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Currax Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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TrialMed Birmingham (DRS)
Birmingham, Alabama, United States
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
Velocity Clinical Research, Denver
Englewood, Colorado, United States
ABMED Clinical Research
Cape Coral, Florida, United States
LMG Research
Coral Gables, Florida, United States
JY Research Institute
Cutler Bay, Florida, United States
Delray Physician Center
Delray Beach, Florida, United States
D&H Doral Research Center
Doral, Florida, United States
Accel Research Sites Network - Edgewater
Edgewater, Florida, United States
Velocity Clinical Research (New Smyrna Beach)
Edgewater, Florida, United States
IMRC Fort Lauderdale
Fort Lauderdale, Florida, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
G+C Research Group
Hialeah, Florida, United States
Qway Research
Hialeah, Florida, United States
Conveinent Medical Research
Hialeah, Florida, United States
Ilumina Medical Research
Kissimmee, Florida, United States
Altus Research
Lake Worth, Florida, United States
D&H Pompano Research Center, LLC
Margate, Florida, United States
Optimal Research, LLC. - Melbourne
Melbourne, Florida, United States
Advanced Clinical Research
Miami, Florida, United States
Medical Research Center Westchester
Miami, Florida, United States
Century Research
Miami, Florida, United States
ITB Research
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Janus Clinical Research
Miami, Florida, United States
Miami Beach Clinical Research
Miami Beach, Florida, United States
Innovia Research Center
Miramar, Florida, United States
Healix Clinical Research
New Smyrna Beach, Florida, United States
Biscayne Clinical Research Inc
North Miami, Florida, United States
IMRC At Palmetto Bay
Palmetto Bay, Florida, United States
New Horizons Research
Palmetto Bay, Florida, United States
Best Choice Medical and Research Services
Pembroke Pines, Florida, United States
Bolanos Clnical Research
Pembroke Pines, Florida, United States
Cordova Research Institute
Sweetwater, Florida, United States
D&H Tamarac Research Center, LLC
Tamarac, Florida, United States
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, United States
Advanced Clinical Research Atlanta
Atlanta, Georgia, United States
Clincept Clinical Research
Columbus, Georgia, United States
Accel Research Sites (ARSN) - Neurostudies
Decatur, Georgia, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
NextStage Clinical Research-Chicago
Glen Ellyn, Illinois, United States
JAELEX Research
Round Lake Beach, Illinois, United States
Indiana Medical Research Institute
Merriville, Indiana, United States
Velocity Clinical Research
Valparaiso, Indiana, United States
Velocity Clinical Research
Sioux City, Iowa, United States
AMR - El Dorado
El Dorado, Kansas, United States
Velocity Clinical Research, Kansas City
Kansas City, Kansas, United States
AMR Wichita West
Wichita, Kansas, United States
AMR Wichita East
Wichita, Kansas, United States
Wichita Surgical Specialists
Wichita, Kansas, United States
Velocity Clinical Research
Baton Rouge, Louisiana, United States
Tandem Clinical Research
Covington, Louisiana, United States
Velocity Clinical Research
Covington, Louisiana, United States
Velocity Clinical Research
Lafayette, Louisiana, United States
AMR New Orleans
New Orleans, Louisiana, United States
Velocity Clinical Research, New Orleans
New Orleans, Louisiana, United States
Velocity Clinical Research
Slidell, Louisiana, United States
Regenerative Orthopedics and Sports Medicine- NextStage Clinical Research
North Bethesda, Maryland, United States
Advanced Primary Care & Geriatrics/CCT Research
Rockville, Maryland, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
Activmed Practices and Research, Inc
Methuen, Massachusetts, United States
Dearborn Cardiology
Dearborn, Michigan, United States
Velocity Clinical Research
Gulfport, Mississippi, United States
Clay Platte Family Medicine
Kansas City, Missouri, United States
St. Louis Medical Professionals/CCT Research
St Louis, Missouri, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Velocity Clinical Research at Pioneer Heart Institute
Lincoln, Nebraska, United States
Velocity Clinical Research
Lincoln, Nebraska, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Meridian Clinical Research - Velocity
Omaha, Nebraska, United States
Midwest Regional Health Services
Omaha, Nebraska, United States
Avacare
Las Vegas, Nevada, United States
Santa Rosa Urgent Care Primary Care/CCT Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, United States
Velocity Clinical Research
Albuquerque, New Mexico, United States
Axces Research Group
Santa Fe, New Mexico, United States
Velocity Clinical Research
Binghamton, New York, United States
Synexus Clinical Research US, Inc. - New York
New York, New York, United States
Velocity Clinical Research
Vestal, New York, United States
Velocity Clinical Research, Durham
Durham, North Carolina, United States
Velocity Clinical Research
Beachwood, Ohio, United States
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, United States
Velocity Clinical Research, Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
NexGen Research
Lima, Ohio, United States
NextStage Clinical Research - Tulsa
Tulsa, Oklahoma, United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Hatboro Medical Associates/Avacare Research
Horsham, Pennsylvania, United States
Mercado Medical Practice/CCT Research
Philadelphia, Pennsylvania, United States
Velocity Clinical Research (Providence)
East Greenwich, Rhode Island, United States
Velocity Clinical Research
Anderson, South Carolina, United States
Velocity Clinical Research
Charleston, South Carolina, United States
Velocity Clinical Research
Columbia, South Carolina, United States
Velocity Clinical Research
Gaffney, South Carolina, United States
Velocity Clinical Research
Greenville, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, United States
Velocity Clinical Research, Union
Union, South Carolina, United States
Velocity Clinical Research, Abilene
Abilene, Texas, United States
Optimal Research, LLC. - Austin
Austin, Texas, United States
Velocity Clinical Research
Austin, Texas, United States
Advanced Cardiovascular Specialists/NextStage Clinical Research
Beaumont, Texas, United States
HDH Research
Houston, Texas, United States
All-American Orthopedics-NextStage Clinical Research
Houston, Texas, United States
NextStage Clinical Research-Lubbock/SWAT Surgical Associates-NextStage Clinical Research
Lubbock, Texas, United States
NextStage Clinical Research-Port Arthur/Gulf Coast Cardiology
Port Arthur, Texas, United States
Synexus Clinical Research US; Inc.
San Antonio, Texas, United States
Olympus Clinical Research
Sugarland, Texas, United States
Waco Cardiology Consultants
Waco, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Velocity Clinical Research, Hampton
Hampton, Virginia, United States
AMR Norfolk
Norfolk, Virginia, United States
Velocity Clinical Research, Suffolk, VA
Suffolk, Virginia, United States
Evergreen Surgical
Eau Claire, Wisconsin, United States
Countries
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Facility Contacts
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Ramy Toma, MD
Role: primary
Faheem Shaikh, MD
Role: primary
Harry Studdard, MD
Role: primary
Amy McCoy, MD
Role: primary
Juan Rodriguez, MD
Role: primary
David Shockey, MD
Role: primary
Steven Plimpton
Role: primary
Thomas Fiel, MD
Role: primary
Kevin Pounds, MD
Role: primary
Dennis Tsang, MD
Role: primary
Thaidra Gaufin, MD
Role: primary
Stanley Hsia, MD
Role: primary
Scott Overcash, MD
Role: primary
Pamela De Silva, MD
Role: primary
Barry Heller, MD
Role: primary
Abdul Khan, MD
Role: primary
Mallu Reddy, MD
Role: primary
Judith Kirstein, MD
Role: primary
Bernadette Alejandrino, MD
Role: primary
Robert Williams
Role: primary
Luis Cabrera, MD
Role: primary
Nelson Gonzalez, MD
Role: primary
Yvon Petiote, MD
Role: primary
Ana Cury, MD
Role: primary
Margaret Chang, MD
Role: primary
Ihosvani Miguel, MD
Role: primary
Jose Rodriguez, MD
Role: primary
Miguel Chamah,, MD
Role: primary
Jose Barbeito, MD
Role: primary
Luis Alvarado, MD
Role: primary
Samuel Lederman, MD
Role: primary
Jorge Amaya, MD
Role: primary
Murray Kimmel, MD
Role: primary
Lazzaro Garcia, MD
Role: primary
Armando Velez-Pineda, MD
Role: primary
Jacqueline Alvarez
Role: primary
Adolfo Cueli, MD
Role: primary
Julian Guerrero, MD
Role: primary
Ricardo Mauro Perez Rivera, MD
Role: primary
Emilio Pando
Role: primary
Abigail Adams, MD
Role: primary
Anita Petteway, MD
Role: primary
Luis Hernandez Rosado, MD
Role: primary
Derrick Diaz
Role: primary
Franklin Pimentel, MD
Role: primary
Yaolen Bolanos, MD
Role: primary
Guillermo Somodevilla, MD
Role: primary
Eric Spivack, MD
Role: primary
Angela Okolie, MD
Role: primary
Courtney Shelton, MD
Role: primary
Anthony Olofintuyi, MD
Role: primary
Ramana Puppala, MD
Role: primary
Paul Bradley, MD
Role: primary
Arshad Malik, MD
Role: primary
Robert Buynak, MD
Role: primary
Nicholas Bechtold, MD
Role: primary
Michael Rausch, MD
Role: primary
Terry Klein, MD
Role: primary
Nicholas Brown, MD
Role: primary
Katherine Pearce, MD
Role: primary
Tania Levi, MD
Role: primary
William Beacham, MD
Role: primary
Jibran Atwi, MD
Role: primary
Scott Striplin, MD
Role: primary
Ravi Passi, MD
Role: primary
Shishir Khetan, MD
Role: primary
Adam Tanzer, MD
Role: primary
Paul Matherne, MD
Role: primary
Scott Kuennen, MD
Role: primary
Hany Salama, MD
Role: primary
Adam Brosz, MD
Role: primary
Jay Meyer, MD
Role: primary
Charles Harper, MD
Role: primary
Frederick Raiser, MD
Role: primary
Rita Chuang, MD
Role: primary
Alton Walters, MD
Role: primary
Sara Friedman, MD
Role: primary
Frank Eder, MD
Role: primary
William Cromwell, MD
Role: primary
Margaret Rhee, MD
Role: primary
Matthew Wenker, MD
Role: primary
Audrius Rauksenas, MD
Role: primary
Charles Eger, MD
Role: primary
Nonso Ezema, MD
Role: primary
Brian Chalkin, MD
Role: primary
Sarah Smiley, MD
Role: primary
Harris Cohen, MD
Role: primary
David Fried, MD
Role: primary
Charles Thompson, MD
Role: primary
Ronald Cassada, MD
Role: primary
David Erb, MD
Role: primary
Kelly Morales, MD
Role: primary
Farhan Siddiqui, MD
Role: primary
Joseph Boscia, MD
Role: primary
Thomas Headstream, MD
Role: primary
Kristie Miller, MD
Role: primary
Michael Zimmerman, MD
Role: primary
Jorge Hernandez, MD
Role: primary
Francisco Ortiz, MD
Role: primary
Matthew Higgs, MD
Role: primary
Pradip Morbia, MD
Role: primary
Danielle Coulter, MD
Role: primary
Harish Thakker, MD
Role: primary
Donald Cross, MD
Role: primary
Barbara Rizzardi, MD
Role: primary
Kristen Holtz, MD
Role: primary
Thomas Piscitelli, MD
Role: primary
Mary Bailey, MD
Role: primary
Banu Myneni, MD
Role: primary
Other Identifiers
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NB-CVOT3
Identifier Type: -
Identifier Source: org_study_id