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ACTIVE NOT RECRUITING

NCT06098079

PHASE4

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

Sponsor: Currax Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: A Phase IV Study to Assess the Effect of Naltrexone Hydrochloride Extended Release (ER) and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on the Occurrence of Major Adverse Cardiovascular Events

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8600

Start Date

2024-01-03

Completion Date

2029-07

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Obesity

Interventions

DRUG

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.

DRUG

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.

Inclusion Criteria: 1. Patient age ≥18 years at screening 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: 1. Using prescription medications, other than Contrave/Mysimba, or surgical or medical device interventions for weight loss 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

Locations (140)

TrialMed Birmingham (DRS)

Birmingham, Alabama, United States

Accel Research Sites Network

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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

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

Praveen K Gupta, MD/Avacare

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 (St. Louis)

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

And 40 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (140)