8,600-Person study probes contrave heart safety

NCT ID NCT06098079

Disease control Sponsor: Currax Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the weight-loss medication Contrave (naltrexone/bupropion) increases the risk of serious heart problems like heart attacks, strokes, or heart-related death. About 8,600 obese or overweight adults with heart risk factors will be randomly assigned to take Contrave or a placebo. Researchers will compare how many people in each group have a heart event over time to see if the drug is safe for long-term use.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 8,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

ABMED Clinical Research

Cape Coral, Florida, 33914, United States
AMR - El Dorado

El Dorado, Kansas, 67042, United States
AMR Mobile

Mobile, Alabama, 36608, United States
AMR New Orleans

New Orleans, Louisiana, 70119, United States
AMR Norfolk

Norfolk, Virginia, 23502, United States
AMR Wichita East

Wichita, Kansas, 67207, United States
AMR Wichita West

Wichita, Kansas, 67205, United States
Accel Research Sites (ARSN) - Neurostudies

Decatur, Georgia, 30030, United States
Accel Research Sites Network

Birmingham, Alabama, 35216, United States
Accel Research Sites Network - Edgewater

Edgewater, Florida, 32132, United States
ActivMed Practices and Research

Portsmouth, New Hampshire, 03801, United States
Activmed Practices and Research, Inc

Methuen, Massachusetts, 01844, United States
Advanced Cardiovascular Specialists/NextStage Clinical Research

Beaumont, Texas, 77702, United States
Advanced Clinical Research

Miami, Florida, 33156, United States
Advanced Clinical Research Atlanta

Atlanta, Georgia, 30309, United States
All-American Orthopedics-NextStage Clinical Research

Houston, Texas, 77058, United States
Altus Research

Lake Worth, Florida, 33461, United States
Avacare

Las Vegas, Nevada, 89102, United States
Axces Research Group

Santa Fe, New Mexico, 87505, United States
Best Choice Medical and Research Services

Pembroke Pines, Florida, 33024, United States
Biscayne Clinical Research Inc

North Miami, Florida, 33169, United States
Bolanos Clnical Research

Pembroke Pines, Florida, 33028, United States
Cardiovascular Consultants/NextStage Clinical Research

Glendale, Arizona, 85306, United States
Century Research

Miami, Florida, 33173, United States
Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States
Chemidox Clinical Trials Inc.

Lancaster, California, 93534, United States
Clay Platte Family Medicine

Kansas City, Missouri, 64151, United States
Clincept Clinical Research

Columbus, Georgia, 31904, United States
Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States
Conveinent Medical Research

Hialeah, Florida, 33013, United States
Cordova Research Institute

Sweetwater, Florida, 33182, United States
Cullman Clinical Trials

Cullman, Alabama, 35055, United States
D&H Doral Research Center

Doral, Florida, 33122, United States
D&H Pompano Research Center, LLC

Margate, Florida, 33063, United States
D&H Tamarac Research Center, LLC

Tamarac, Florida, 33321, United States
Dearborn Cardiology

Dearborn, Michigan, 48126, United States
Delray Physician Center

Delray Beach, Florida, 33445, United States
Desert Clinical Research

Mesa, Arizona, 85213, United States
Entrust Clinical Research

Miami, Florida, 33176, United States
Evergreen Surgical

Eau Claire, Wisconsin, 54701, United States
Fiel Family & Sports Medicine CCT Research

Tempe, Arizona, 85283, United States
G+C Research Group

Hialeah, Florida, 33010, United States
HDH Research

Houston, Texas, 77022, United States
Hatboro Medical Associates/Avacare Research

Horsham, Pennsylvania, 19044, United States
Healix Clinical Research

New Smyrna Beach, Florida, 32168, United States
IMRC At Palmetto Bay

Palmetto Bay, Florida, 33157, United States
IMRC Fort Lauderdale

Fort Lauderdale, Florida, 33316, United States
ITB Research

Miami, Florida, 33173, United States
Ilumina Medical Research

Kissimmee, Florida, 34744, United States
Indiana Medical Research Institute

Merriville, Indiana, 46410, United States
Innovia Research Center

Miramar, Florida, 33027, United States
JAELEX Research

Round Lake Beach, Illinois, 60073, United States
JY Research Institute

Cutler Bay, Florida, 33189, United States
Janus Clinical Research

Miami, Florida, 33186, United States
LMG Research

Coral Gables, Florida, 33134, United States
Las Vegas Clinical Trials

North Las Vegas, Nevada, 89119, United States
Long Beach Clinical Trials

Long Beach, California, 90806, United States
Medical Research Center Westchester

Miami, Florida, 33165, United States
Mercado Medical Practice/CCT Research

Philadelphia, Pennsylvania, 19111, United States
Meridian Clinical Research - Velocity

Omaha, Nebraska, 68134, United States
Miami Beach Clinical Research

Miami Beach, Florida, 33141, United States
Midwest Regional Health Services

Omaha, Nebraska, 68144, United States
National Institute of Clinical Research, Inc.

Pomona, California, 91768, United States
New Horizons Research

Palmetto Bay, Florida, 33176, United States
NexGen Research

Lima, Ohio, 45801, United States
NextStage Clinical Research - Tulsa

Tulsa, Oklahoma, 74136, United States
NextStage Clinical Research-Chicago

Glen Ellyn, Illinois, 60137, United States
NextStage Clinical Research-Lubbock/SWAT Surgical Associates-NextStage Clinical Research

Lubbock, Texas, 79410, United States
NextStage Clinical Research-Port Arthur/Gulf Coast Cardiology

Port Arthur, Texas, 77642, United States
Olympus Clinical Research

Sugarland, Texas, 77479, United States
Optimal Research, LLC. - Austin

Austin, Texas, 78705, United States
Optimal Research, LLC. - Melbourne

Melbourne, Florida, 32934, United States
Praveen K Gupta, MD/Avacare

Rockville, Maryland, 20852, United States
Providere Research

West Covina, California, 91790, United States
Qway Research

Hialeah, Florida, 33010, United States
Regenerative Orthopedics and Sports Medicine- NextStage Clinical Research

North Bethesda, Maryland, 20852, United States
Santa Rosa Urgent Care Primary Care/CCT Research

Las Vegas, Nevada, 89119, United States
Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States
St. Louis Medical Professionals/CCT Research

St Louis, Missouri, 63119, United States
Sun City Research

Glendale, Arizona, 85304, United States
Synexus Clinical Research US, Inc. - New York

New York, New York, 10017, United States
Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, 32162, United States
Synexus Clinical Research US; Inc.

Tucson, Arizona, 85741, United States
Synexus Clinical Research US; Inc.

San Antonio, Texas, 78229, United States
TrialMed Birmingham (DRS)

Birmingham, Alabama, 35211, United States
Valley Vitality Ventures

Manteca, California, 95350, United States
Velocity Clinical Research

Chula Vista, California, 91911, United States
Velocity Clinical Research

Los Angeles, California, 90057, United States
Velocity Clinical Research

Valparaiso, Indiana, 46383, United States
Velocity Clinical Research

Sioux City, Iowa, 51106, United States
Velocity Clinical Research

Baton Rouge, Louisiana, 70809, United States
Velocity Clinical Research

Covington, Louisiana, 70433, United States
Velocity Clinical Research

Lafayette, Louisiana, 70508, United States
Velocity Clinical Research

Slidell, Louisiana, 70458, United States
Velocity Clinical Research

Gulfport, Mississippi, 39503, United States
Velocity Clinical Research

Lincoln, Nebraska, 68510, United States
Velocity Clinical Research

Albuquerque, New Mexico, 87107, United States
Velocity Clinical Research

Binghamton, New York, 13905, United States
Velocity Clinical Research

Vestal, New York, 13850, United States
Velocity Clinical Research

Beachwood, Ohio, 44122, United States
Velocity Clinical Research

Cincinnati, Ohio, 45246, United States
Velocity Clinical Research

Anderson, South Carolina, 29621, United States
Velocity Clinical Research

Charleston, South Carolina, 29414, United States
Velocity Clinical Research

Columbia, South Carolina, 29204, United States
Velocity Clinical Research

Gaffney, South Carolina, 29340, United States
Velocity Clinical Research

Greenville, South Carolina, 29615, United States
Velocity Clinical Research

Austin, Texas, 78759, United States
Velocity Clinical Research (New Smyrna Beach)

Edgewater, Florida, 32132, United States
Velocity Clinical Research (Providence)

East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research (St. Louis)

St Louis, Missouri, 63131, United States
Velocity Clinical Research at Coastal Heart Medical Group

Santa Ana, California, 92704, United States
Velocity Clinical Research at Pioneer Heart Institute

Lincoln, Nebraska, 68506, United States
Velocity Clinical Research of Santa Ana

Santa Ana, California, 92704, United States
Velocity Clinical Research, Abilene

Abilene, Texas, 79606, United States
Velocity Clinical Research, Cincinnati

Cincinnati, Ohio, 45242, United States
Velocity Clinical Research, Denver

Englewood, Colorado, 80110, United States
Velocity Clinical Research, Durham

Durham, North Carolina, 27701, United States
Velocity Clinical Research, Gardena

Anderson, California, 90247, United States
Velocity Clinical Research, Grand Island

Grand Island, Nebraska, 68803, United States
Velocity Clinical Research, Grants Pass

Grants Pass, Oregon, 97527, United States
Velocity Clinical Research, Hampton

Hampton, Virginia, 23666, United States
Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States
Velocity Clinical Research, Kansas City

Kansas City, Kansas, 66210, United States
Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States
Velocity Clinical Research, Mobile

Mobile, Alabama, 36608, United States
Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, 45219, United States
Velocity Clinical Research, New Orleans

New Orleans, Louisiana, 70119, United States
Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States
Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85006, United States
Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States
Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States
Velocity Clinical Research, San Bernardino

San Bernardino, California, 92408, United States
Velocity Clinical Research, San Diego

La Mesa, California, 91942, United States
Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States
Velocity Clinical Research, Spartanburg

Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research, Suffolk, VA

Suffolk, Virginia, 23435, United States
Velocity Clinical Research, Union

Union, South Carolina, 29379, United States
Velocity Clinical Research, Van Nuys

Van Nuys, California, 91405, United States
Waco Cardiology Consultants

Waco, Texas, 76712, United States
Wichita Surgical Specialists

Wichita, Kansas, 67214, United States

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