Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
Purpose
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor will be blinded
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Naltrexone/Bupropion (NB) |
Patients will be randomly assigned to NB (naltrexone 8 mg and bupropion 90 mg) extended-release oral tablet. |
|
|
Placebo Comparator Placebo |
Patients will be randomly assigned to placebo. |
|
Recruiting Locations
Accel Research Sites Network
Birmingham, Alabama 35216
Birmingham, Alabama 35216
Velocity Clinical Research, Mobile
Mobile, Alabama 36608
Mobile, Alabama 36608
Cardiovascular Consultants/NextStage Clinical Research
Glendale, Arizona 85306
Glendale, Arizona 85306
Velocity Clinical Research, Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Fiel Family & Sports Medicine CCT Research
Tempe, Arizona 85283
Tempe, Arizona 85283
Velocity Clinical Research, Gardena
Anderson, California 90247
Anderson, California 90247
Velocity Clinical Research
Chula Vista, California 91911
Chula Vista, California 91911
Velocity Clinical Research, Huntington Park
Huntington Park, California 90255
Huntington Park, California 90255
Velocity Clinical Research, San Diego
La Mesa, California 91942
La Mesa, California 91942
Chemidox Clinical Trials Inc.
Lancaster, California 93534
Lancaster, California 93534
Velocity Clinical Research, San Bernardino
San Bernardino, California 92408
San Bernardino, California 92408
Providere Research
West Covina, California 91790
West Covina, California 91790
Velocity Clinical Research, Denver
Englewood, Colorado 80110
Englewood, Colorado 80110
LMG Research
Coral Gables, Florida 33134
Coral Gables, Florida 33134
JY Research Institute
Cutler Bay, Florida 33189
Cutler Bay, Florida 33189
Delray Physician Center
Delray Beach, Florida 33445
Delray Beach, Florida 33445
Velocity Clinical Research (New Smyrna Beach)
Edgewater, Florida 32132
Edgewater, Florida 32132
IMRC Fort Lauderdale
Fort Lauderdale, Florida 33316
Fort Lauderdale, Florida 33316
Southwest General Healthcare Center
Fort Myers, Florida 33907
Fort Myers, Florida 33907
G+C Research Group
Hialeah, Florida 33010
Hialeah, Florida 33010
Conveinent Medical Research
Hialeah, Florida 33013
Hialeah, Florida 33013
Ilumina Medical Research
Kissimmee, Florida 34744
Kissimmee, Florida 34744
Optimal Research, LLC. - Melbourne
Melbourne, Florida 32934
Melbourne, Florida 32934
Miami Beach Clinical Research
Miami Beach, Florida 33141
Miami Beach, Florida 33141
Advanced Clinical Research
Miami, Florida 33156
Miami, Florida 33156
Medical Research Center Westchester
Miami, Florida 33165
Miami, Florida 33165
Century Research
Miami, Florida 33173
Miami, Florida 33173
Entrust Clinical Research
Miami, Florida 33176
Miami, Florida 33176
Janus Clinical Research
Miami, Florida 33186
Miami, Florida 33186
Innovia Research Center
Miramar, Florida 33027
Miramar, Florida 33027
Biscayne Clinical Research Inc
North Miami, Florida 33169
North Miami, Florida 33169
IMRC At Palmetto Bay
Palmetto Bay, Florida 33157
Palmetto Bay, Florida 33157
New Horizons Research
Palmetto Bay, Florida 33176
Palmetto Bay, Florida 33176
Best Choice Medical and Research Services
Pembroke Pines, Florida 33024
Pembroke Pines, Florida 33024
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida 32162
The Villages, Florida 32162
Advanced Clinical Research Atlanta
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Clincept Clinical Research
Columbus, Georgia 31904
Columbus, Georgia 31904
Accel Research Sites (ARSN) - Neurostudies
Decatur, Georgia 30030
Decatur, Georgia 30030
Velocity Clinical Research, Savannah
Savannah, Georgia 31406
Savannah, Georgia 31406
Velocity Clinical Research
Valparaiso, Indiana 46383
Valparaiso, Indiana 46383
Velocity Clinical Research
Sioux City, Iowa 51106
Sioux City, Iowa 51106
AMR - El Dorado
El Dorado, Kansas 67042
El Dorado, Kansas 67042
AMR Wichita East
Wichita, Kansas 67207
Wichita, Kansas 67207
Wichita Surgical Specialists
Wichita, Kansas 67214
Wichita, Kansas 67214
Velocity Clinical Research
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Velocity Clinical Research
Covington, Louisiana 70433
Covington, Louisiana 70433
Velocity Clinical Research
Lafayette, Louisiana 70508
Lafayette, Louisiana 70508
Velocity Clinical Research, New Orleans
New Orleans, Louisiana 70119
New Orleans, Louisiana 70119
Advanced Primary Care & Geriatrics/CCT Research
Rockville, Maryland 20850
Rockville, Maryland 20850
Velocity Clinical Research, Rockville
Rockville, Maryland 20854
Rockville, Maryland 20854
Activmed Practices and Research, Inc
Methuen, Massachusetts 01844
Methuen, Massachusetts 01844
Velocity Clinical Research
Gulfport, Mississippi 39503
Gulfport, Mississippi 39503
Clay Platte Family Medicine
Kansas City, Missouri 64151
Kansas City, Missouri 64151
St. Louis Medical Professionals/CCT Research
Saint Louis, Missouri 63119
Saint Louis, Missouri 63119
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
Grand Island, Nebraska 68803
Velocity Clinical Research
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701
Norfolk, Nebraska 68701
Meridian Clinical Research - Velocity
Omaha, Nebraska 68134
Omaha, Nebraska 68134
Healor Primary Care/CCT Research
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas Clinical Trials
North Las Vegas, Nevada 89119
North Las Vegas, Nevada 89119
ActivMed Practices and Research
Portsmouth, New Hampshire 03801
Portsmouth, New Hampshire 03801
Velocity Clinical Research
Albuquerque, New Mexico 87107
Albuquerque, New Mexico 87107
Velocity Clinical Research
Binghamton, New York 13905
Binghamton, New York 13905
Synexus Clinical Research US, Inc. - New York
New York City, New York 10017
New York City, New York 10017
Velocity Clinical Research, Durham
Durham, North Carolina 27701
Durham, North Carolina 27701
Velocity Clinical Research
Beachwood, Ohio 44122
Beachwood, Ohio 44122
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Velocity Clinical Research, Cincinnati
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Velocity Clinical Research
Cincinnati, Ohio 45246
Cincinnati, Ohio 45246
NextStage Clinical Research - Tulsa
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
Velocity Clinical Research, Medford
Medford, Oregon 97504
Medford, Oregon 97504
Mercado Medical Practice/CCT Research
Philadelphia, Pennsylvania 19111
Philadelphia, Pennsylvania 19111
Velocity Clinical Research (Providence)
East Greenwich, Rhode Island 02818
East Greenwich, Rhode Island 02818
Velocity Clinical Research
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Velocity Clinical Research
Columbia, South Carolina 29204
Columbia, South Carolina 29204
Velocity Clinical Research
Gaffney, South Carolina 29340
Gaffney, South Carolina 29340
Coastal Carolina Research Center
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Velocity Clinical Research, Union
Union, South Carolina 29379
Union, South Carolina 29379
Velocity Clinical Research, Abilene
Abilene, Texas 79606
Abilene, Texas 79606
Optimal Research, LLC. - Austin
Austin, Texas 78705
Austin, Texas 78705
Velocity Clinical Research
Austin, Texas 78759
Austin, Texas 78759
Advanced Cardiovascular Specialists/NextStage Clinical Research
Beaumont, Texas 77702
Beaumont, Texas 77702
HDH Research
Houston, Texas 77022
Houston, Texas 77022
All-American Orthopedics-NextStage Clinical Research
Houston, Texas 77058
Houston, Texas 77058
NextStage Clinical Research-Port Arthur/Gulf Coast Cardiology
Port Arthur, Texas 77642
Port Arthur, Texas 77642
Olympus Clinical Research
Sugarland, Texas 77479
Sugarland, Texas 77479
Waco Cardiology Consultants
Waco, Texas 76712
Waco, Texas 76712
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
West Jordan, Utah 84088
Charlottesville Medical Research
Charlottesville, Virginia 22911
Charlottesville, Virginia 22911
Velocity Clinical Research, Hampton
Hampton, Virginia 23666
Hampton, Virginia 23666
AMR Norfolk
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Velocity Clinical Research, Suffolk, VA
Suffolk, Virginia 23435
Suffolk, Virginia 23435
Evergreen Surgical
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
More Details
- NCT ID
- NCT06098079
- Status
- Recruiting
- Sponsor
- Currax Pharmaceuticals
Detailed Description
This multi-center, prospective, randomized, pragmatic, double-blinded study has been designed to capture cardiovascular (CV) outcomes during the real-world use of NB after initial randomization. The aim of the study is to assess whether patients receiving treatment with NB are at an elevated risk of experiencing MACE compared with patients receiving placebo. Both patient groups will also be counselled to lose weight via a reduced-calorie diet and increased physical activity.