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 Sex
- 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 4049979, Alabama 4829764 35216
Birmingham 4049979, Alabama 4829764 35216
AMR Mobile
Mobile 4076598, Alabama 4829764 36608
Mobile 4076598, Alabama 4829764 36608
Velocity Clinical Research, Mobile
Mobile 4076598, Alabama 4829764 36608
Mobile 4076598, Alabama 4829764 36608
Sun City Research
Glendale 5295985, Arizona 5551752 85304
Glendale 5295985, Arizona 5551752 85304
Desert Clinical Research
Mesa 5304391, Arizona 5551752 85213
Mesa 5304391, Arizona 5551752 85213
Velocity Clinical Research, Phoenix
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Fiel Family & Sports Medicine CCT Research
Tempe 5317058, Arizona 5551752 85283
Tempe 5317058, Arizona 5551752 85283
Synexus Clinical Research US; Inc.
Tucson 5318313, Arizona 5551752 85741
Tucson 5318313, Arizona 5551752 85741
Velocity Clinical Research, Gardena
Anderson 5558857, California 5332921 90247
Anderson 5558857, California 5332921 90247
Velocity Clinical Research
Chula Vista 5336899, California 5332921 91911
Chula Vista 5336899, California 5332921 91911
Velocity Clinical Research, Huntington Park
Huntington Park 5358736, California 5332921 90255
Huntington Park 5358736, California 5332921 90255
Velocity Clinical Research, San Diego
La Mesa 5363990, California 5332921 91942
La Mesa 5363990, California 5332921 91942
Chemidox Clinical Trials Inc.
Lancaster 5364940, California 5332921 93534
Lancaster 5364940, California 5332921 93534
Long Beach Clinical Trials
Long Beach 5367929, California 5332921 90806
Long Beach 5367929, California 5332921 90806
Valley Vitality Ventures
Manteca 5370164, California 5332921 95350
Manteca 5370164, California 5332921 95350
National Institute of Clinical Research, Inc.
Pomona 5384170, California 5332921 91768
Pomona 5384170, California 5332921 91768
Velocity Clinical Research, San Bernardino
San Bernardino 5391710, California 5332921 92408
San Bernardino 5391710, California 5332921 92408
Providere Research
West Covina 5407933, California 5332921 91790
West Covina 5407933, California 5332921 91790
Velocity Clinical Research, Denver
Englewood 5421250, Colorado 5417618 80110
Englewood 5421250, Colorado 5417618 80110
LMG Research
Coral Gables 4151871, Florida 4155751 33134
Coral Gables 4151871, Florida 4155751 33134
JY Research Institute
Cutler Bay 6332309, Florida 4155751 33189
Cutler Bay 6332309, Florida 4155751 33189
Delray Physician Center
Delray Beach 4153132, Florida 4155751 33445
Delray Beach 4153132, Florida 4155751 33445
D&H Doral Research Center
Doral 4153471, Florida 4155751 33122
Doral 4153471, Florida 4155751 33122
Velocity Clinical Research (New Smyrna Beach)
Edgewater 4154205, Florida 4155751 32132
Edgewater 4154205, Florida 4155751 32132
IMRC Fort Lauderdale
Fort Lauderdale 4155966, Florida 4155751 33316
Fort Lauderdale 4155966, Florida 4155751 33316
Southwest General Healthcare Center
Fort Myers 4155995, Florida 4155751 33907
Fort Myers 4155995, Florida 4155751 33907
Qway Research
Hialeah 4158476, Florida 4155751 33010
Hialeah 4158476, Florida 4155751 33010
Conveinent Medical Research
Hialeah 4158476, Florida 4155751 33013
Hialeah 4158476, Florida 4155751 33013
Ilumina Medical Research
Kissimmee 4160983, Florida 4155751 34744
Kissimmee 4160983, Florida 4155751 34744
Altus Research
Lake Worth 4161422, Florida 4155751 33461
Lake Worth 4161422, Florida 4155751 33461
D&H Pompano Research Center, LLC
Margate 4163407, Florida 4155751 33063
Margate 4163407, Florida 4155751 33063
Optimal Research, LLC. - Melbourne
Melbourne 4163971, Florida 4155751 32934
Melbourne 4163971, Florida 4155751 32934
Advanced Clinical Research
Miami 4164138, Florida 4155751 33156
Miami 4164138, Florida 4155751 33156
Medical Research Center Westchester
Miami 4164138, Florida 4155751 33165
Miami 4164138, Florida 4155751 33165
ITB Research
Miami 4164138, Florida 4155751 33173
Miami 4164138, Florida 4155751 33173
Entrust Clinical Research
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
Janus Clinical Research
Miami 4164138, Florida 4155751 33186
Miami 4164138, Florida 4155751 33186
Miami Beach Clinical Research
Miami Beach 4164143, Florida 4155751 33141
Miami Beach 4164143, Florida 4155751 33141
Innovia Research Center
Miramar 4164601, Florida 4155751 33027
Miramar 4164601, Florida 4155751 33027
Healix Clinical Research
New Smyrna Beach 4165913, Florida 4155751 32168
New Smyrna Beach 4165913, Florida 4155751 32168
Biscayne Clinical Research Inc
North Miami 4166232, Florida 4155751 33169
North Miami 4166232, Florida 4155751 33169
IMRC At Palmetto Bay
Palmetto Bay 4167634, Florida 4155751 33157
Palmetto Bay 4167634, Florida 4155751 33157
New Horizons Research
Palmetto Bay 4167634, Florida 4155751 33176
Palmetto Bay 4167634, Florida 4155751 33176
Best Choice Medical and Research Services
Pembroke Pines 4168139, Florida 4155751 33024
Pembroke Pines 4168139, Florida 4155751 33024
Bolanos Clnical Research
Pembroke Pines 4168139, Florida 4155751 33028
Pembroke Pines 4168139, Florida 4155751 33028
Cordova Research Institute
Sweetwater 4174600, Florida 4155751 33182
Sweetwater 4174600, Florida 4155751 33182
D&H Tamarac Research Center, LLC
Tamarac 4174738, Florida 4155751 33321
Tamarac 4174738, Florida 4155751 33321
Synexus Clinical Research US, Inc. - The Villages
The Villages 4175179, Florida 4155751 32162
The Villages 4175179, Florida 4155751 32162
Advanced Clinical Research Atlanta
Atlanta 4180439, Georgia 4197000 30309
Atlanta 4180439, Georgia 4197000 30309
Clincept Clinical Research
Columbus 4188985, Georgia 4197000 31904
Columbus 4188985, Georgia 4197000 31904
Accel Research Sites (ARSN) - Neurostudies
Decatur 4191124, Georgia 4197000 30030
Decatur 4191124, Georgia 4197000 30030
Velocity Clinical Research, Savannah
Savannah 4221552, Georgia 4197000 31406
Savannah 4221552, Georgia 4197000 31406
Indiana Medical Research Institute
Merriville, Indiana 4921868 46410
Merriville, Indiana 4921868 46410
Velocity Clinical Research
Valparaiso 4927537, Indiana 4921868 46383
Valparaiso 4927537, Indiana 4921868 46383
Velocity Clinical Research
Sioux City 4876523, Iowa 4862182 51106
Sioux City 4876523, Iowa 4862182 51106
AMR - El Dorado
El Dorado 4270863, Kansas 4273857 67042
El Dorado 4270863, Kansas 4273857 67042
AMR Wichita East
Wichita 4281730, Kansas 4273857 67207
Wichita 4281730, Kansas 4273857 67207
Wichita Surgical Specialists
Wichita 4281730, Kansas 4273857 67214
Wichita 4281730, Kansas 4273857 67214
Velocity Clinical Research
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Velocity Clinical Research
Covington 4321005, Louisiana 4331987 70433
Covington 4321005, Louisiana 4331987 70433
Velocity Clinical Research
Lafayette 4330145, Louisiana 4331987 70508
Lafayette 4330145, Louisiana 4331987 70508
Velocity Clinical Research, New Orleans
New Orleans 4335045, Louisiana 4331987 70119
New Orleans 4335045, Louisiana 4331987 70119
Praveen K Gupta, MD/Avacare
Rockville 4367175, Maryland 4361885 20852
Rockville 4367175, Maryland 4361885 20852
Velocity Clinical Research, Rockville
Rockville 4367175, Maryland 4361885 20854
Rockville 4367175, Maryland 4361885 20854
Activmed Practices and Research, Inc
Methuen 4943828, Massachusetts 6254926 01844
Methuen 4943828, Massachusetts 6254926 01844
Velocity Clinical Research
Gulfport 4428667, Mississippi 4436296 39503
Gulfport 4428667, Mississippi 4436296 39503
Clay Platte Family Medicine
Kansas City 4393217, Missouri 4398678 64151
Kansas City 4393217, Missouri 4398678 64151
Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708 68803
Grand Island 5069297, Nebraska 5073708 68803
Velocity Clinical Research
Lincoln 5072006, Nebraska 5073708 68510
Lincoln 5072006, Nebraska 5073708 68510
Velocity Clinical Research, Norfolk
Norfolk 5073965, Nebraska 5073708 68701
Norfolk 5073965, Nebraska 5073708 68701
Meridian Clinical Research - Velocity
Omaha 5074472, Nebraska 5073708 68134
Omaha 5074472, Nebraska 5073708 68134
Avacare
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151 89119
North Las Vegas 5509403, Nevada 5509151 89119
Velocity Clinical Research
Albuquerque 5454711, New Mexico 5481136 87107
Albuquerque 5454711, New Mexico 5481136 87107
Velocity Clinical Research
Binghamton 5109177, New York 5128638 13905
Binghamton 5109177, New York 5128638 13905
Velocity Clinical Research, Durham
Durham 4464368, North Carolina 4482348 27701
Durham 4464368, North Carolina 4482348 27701
Velocity Clinical Research
Beachwood 5146711, Ohio 5165418 44122
Beachwood 5146711, Ohio 5165418 44122
Velocity Clinical Research, Mt. Auburn
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Velocity Clinical Research, Cincinnati
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45242
Velocity Clinical Research
Cincinnati 4508722, Ohio 5165418 45246
Cincinnati 4508722, Ohio 5165418 45246
NexGen Research
Lima 5160783, Ohio 5165418 45801
Lima 5160783, Ohio 5165418 45801
NextStage Clinical Research - Tulsa
Tulsa 4553433, Oklahoma 4544379 74136
Tulsa 4553433, Oklahoma 4544379 74136
Velocity Clinical Research, Medford
Medford 5740099, Oregon 5744337 97504
Medford 5740099, Oregon 5744337 97504
Hatboro Medical Associates/Avacare Research
Horsham 5194302, Pennsylvania 6254927 19044
Horsham 5194302, Pennsylvania 6254927 19044
Velocity Clinical Research (Providence)
East Greenwich 5221875, Rhode Island 5224323 02818
East Greenwich 5221875, Rhode Island 5224323 02818
Velocity Clinical Research
Anderson 4569298, South Carolina 4597040 29621
Anderson 4569298, South Carolina 4597040 29621
Velocity Clinical Research
Columbia 4575352, South Carolina 4597040 29204
Columbia 4575352, South Carolina 4597040 29204
Velocity Clinical Research
Gaffney 4579418, South Carolina 4597040 29340
Gaffney 4579418, South Carolina 4597040 29340
Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040 29405
North Charleston 4589387, South Carolina 4597040 29405
Velocity Clinical Research, Spartanburg
Spartanburg 4597200, South Carolina 4597040 29303
Spartanburg 4597200, South Carolina 4597040 29303
Velocity Clinical Research, Union
Union 4599214, South Carolina 4597040 29379
Union 4599214, South Carolina 4597040 29379
Velocity Clinical Research, Abilene
Abilene 4669635, Texas 4736286 79606
Abilene 4669635, Texas 4736286 79606
Optimal Research, LLC. - Austin
Austin 4671654, Texas 4736286 78705
Austin 4671654, Texas 4736286 78705
Velocity Clinical Research
Austin 4671654, Texas 4736286 78759
Austin 4671654, Texas 4736286 78759
Advanced Cardiovascular Specialists/NextStage Clinical Research
Beaumont 4672989, Texas 4736286 77702
Beaumont 4672989, Texas 4736286 77702
HDH Research
Houston 4699066, Texas 4736286 77022
Houston 4699066, Texas 4736286 77022
All-American Orthopedics-NextStage Clinical Research
Houston 4699066, Texas 4736286 77058
Houston 4699066, Texas 4736286 77058
NextStage Clinical Research-Port Arthur/Gulf Coast Cardiology
Port Arthur 4720039, Texas 4736286 77642
Port Arthur 4720039, Texas 4736286 77642
Synexus Clinical Research US; Inc.
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Olympus Clinical Research
Sugarland, Texas 4736286 77479
Sugarland, Texas 4736286 77479
Waco Cardiology Consultants
Waco 4739526, Texas 4736286 76712
Waco 4739526, Texas 4736286 76712
Velocity Clinical Research, Salt Lake City
West Jordan 5784549, Utah 5549030 84088
West Jordan 5784549, Utah 5549030 84088
Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928 22911
Charlottesville 4752031, Virginia 6254928 22911
Velocity Clinical Research, Hampton
Hampton 4762894, Virginia 6254928 23666
Hampton 4762894, Virginia 6254928 23666
AMR Norfolk
Norfolk 4776222, Virginia 6254928 23502
Norfolk 4776222, Virginia 6254928 23502
Velocity Clinical Research, Suffolk, VA
Suffolk 4788158, Virginia 6254928 23435
Suffolk 4788158, Virginia 6254928 23435
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.