ObesityPhase 4INFORMUSNCT06098079
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
A Phase 4 study testing Naltrexone-Bupropion (NB) Combination in people with Obesity, run by Currax Pharmaceuticals at 140 sites in United States.
Trial summary
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Naltrexone-Bupropion (NB) Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,600 participants
- Where
- 140 sitesUnited States
- Study dates
- 3 Jan 2024to Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥18 years at screening
- 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
- 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)
- 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
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- 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
- Patients who have completed a washout (2-weeks or 5 half-lives, whichever is longer) of the prohibited concomitant medication(s) at screening
- Subject willing to comply with daily completion of an eDiary using a mobile smartphone application
Who cannot join
- Using prescription medications, other than Contrave/Mysimba, or surgical or medical device interventions for weight loss
- History of MI or stroke within 90 days prior to screening
- 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
- 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]),
Show all 18Show fewer
- Hemodynamic instability, including patients with severe heart failure (New York Heart Association Class IV)
- Seizure disorders or history of seizures, not including subjects with a history of pediatric febrile seizures
- Use of other bupropion-containing products (including but not limited to Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin)
- Active anorexia nervosa or bulimia
- 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
- Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
- 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.
- 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
- Known allergy to bupropion, naltrexone, or any other component of Contrave/Mysimba
- Pregnant or nursing
- Known life-threatening arrythmias, including Brugada syndrome
- Participation in any other concurrent investigational trial
Trial locations and contacts
140 sites in 1 country.
140 sites in 1 country
United States140 sites
Velocity Clinical Research, Abilene
Abilene, Texas, 79606
Velocity Clinical Research
Albuquerque, New Mexico, 87107
Velocity Clinical Research, Gardena
Anderson, California, 90247
Velocity Clinical Research
Anderson, South Carolina, 29621
Advanced Clinical Research Atlanta
Atlanta, Georgia, 30309
Optimal Research, LLC. - Austin
Austin, Texas, 78705
Velocity Clinical Research
Austin, Texas, 78759
Velocity Clinical Research
Baton Rouge, Louisiana, 70809
Velocity Clinical Research
Beachwood, Ohio, 44122
Advanced Cardiovascular Specialists/NextStage Clinical Research
Beaumont, Texas, 77702
Velocity Clinical Research
Binghamton, New York, 13905
TrialMed Birmingham (DRS)
Birmingham, Alabama, 35211
Accel Research Sites Network
Birmingham, Alabama, 35216
ABMED Clinical Research
Cape Coral, Florida, 33914
Velocity Clinical Research
Charleston, South Carolina, 29414
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Velocity Clinical Research
Chula Vista, California, 91911
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, 45219
Velocity Clinical Research, Cincinnati
Cincinnati, Ohio, 45242
Velocity Clinical Research
Cincinnati, Ohio, 45246
Velocity Clinical Research
Columbia, South Carolina, 29204
Clincept Clinical Research
Columbus, Georgia, 31904
LMG Research
Coral Gables, Florida, 33134
Velocity Clinical Research
Covington, Louisiana, 70433
Cullman Clinical Trials
Cullman, Alabama, 35055
JY Research Institute
Cutler Bay, Florida, 33189
Dearborn Cardiology
Dearborn, Michigan, 48126
Accel Research Sites (ARSN) - Neurostudies
Decatur, Georgia, 30030
Delray Physician Center
Delray Beach, Florida, 33445
D&H Doral Research Center
Doral, Florida, 33122
Velocity Clinical Research, Durham
Durham, North Carolina, 27701
Velocity Clinical Research (Providence)
East Greenwich, Rhode Island, 02818
Evergreen Surgical
Eau Claire, Wisconsin, 54701
Accel Research Sites Network - Edgewater
Edgewater, Florida, 32132
Velocity Clinical Research (New Smyrna Beach)
Edgewater, Florida, 32132
AMR - El Dorado
El Dorado, Kansas, 67042
Velocity Clinical Research, Denver
Englewood, Colorado, 80110
IMRC Fort Lauderdale
Fort Lauderdale, Florida, 33316
Southwest General Healthcare Center
Fort Myers, Florida, 33907
Velocity Clinical Research
Gaffney, South Carolina, 29340
NextStage Clinical Research-Chicago
Glen Ellyn, Illinois, 60137
Sun City Research
Glendale, Arizona, 85304
Cardiovascular Consultants/NextStage Clinical Research
Glendale, Arizona, 85306
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
Velocity Clinical Research
Greenville, South Carolina, 29615
Velocity Clinical Research
Gulfport, Mississippi, 39503
Velocity Clinical Research, Hampton
Hampton, Virginia, 23666
G+C Research Group
Hialeah, Florida, 33010
Qway Research
Hialeah, Florida, 33010
Conveinent Medical Research
Hialeah, Florida, 33013
Hatboro Medical Associates/Avacare Research
Horsham, Pennsylvania, 19044
HDH Research
Houston, Texas, 77022
All-American Orthopedics-NextStage Clinical Research
Houston, Texas, 77058
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Velocity Clinical Research, Kansas City
Kansas City, Kansas, 66210
Clay Platte Family Medicine
Kansas City, Missouri, 64151
Ilumina Medical Research
Kissimmee, Florida, 34744
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Velocity Clinical Research
Lafayette, Louisiana, 70508
Altus Research
Lake Worth, Florida, 33461
Chemidox Clinical Trials Inc.
Lancaster, California, 93534
Avacare
Las Vegas, Nevada, 89102
Santa Rosa Urgent Care Primary Care/CCT Research
Las Vegas, Nevada, 89119
NexGen Research
Lima, Ohio, 45801
Velocity Clinical Research at Pioneer Heart Institute
Lincoln, Nebraska, 68506
Velocity Clinical Research
Lincoln, Nebraska, 68510
Long Beach Clinical Trials
Long Beach, California, 90806
Velocity Clinical Research
Los Angeles, California, 90057
NextStage Clinical Research-Lubbock/SWAT Surgical Associates-NextStage Clinical Research
Lubbock, Texas, 79410
Valley Vitality Ventures
Manteca, California, 95350
D&H Pompano Research Center, LLC
Margate, Florida, 33063
Velocity Clinical Research, Medford
Medford, Oregon, 97504
Optimal Research, LLC. - Melbourne
Melbourne, Florida, 32934
Indiana Medical Research Institute
Merriville, Indiana, 46410
Desert Clinical Research
Mesa, Arizona, 85213
Activmed Practices and Research, Inc
Methuen, Massachusetts, 01844
Advanced Clinical Research
Miami, Florida, 33156
Medical Research Center Westchester
Miami, Florida, 33165
Century Research
Miami, Florida, 33173
ITB Research
Miami, Florida, 33173
Entrust Clinical Research
Miami, Florida, 33176
Janus Clinical Research
Miami, Florida, 33186
Miami Beach Clinical Research
Miami Beach, Florida, 33141
Innovia Research Center
Miramar, Florida, 33027
AMR Mobile
Mobile, Alabama, 36608
Velocity Clinical Research, Mobile
Mobile, Alabama, 36608
AMR New Orleans
New Orleans, Louisiana, 70119
Velocity Clinical Research, New Orleans
New Orleans, Louisiana, 70119
Healix Clinical Research
New Smyrna Beach, Florida, 32168
Synexus Clinical Research US, Inc. - New York
New York, New York, 10017
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
AMR Norfolk
Norfolk, Virginia, 23502
Regenerative Orthopedics and Sports Medicine- NextStage Clinical Research
North Bethesda, Maryland, 20852
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89119
Biscayne Clinical Research Inc
North Miami, Florida, 33169
Meridian Clinical Research - Velocity
Omaha, Nebraska, 68134
Midwest Regional Health Services
Omaha, Nebraska, 68144
IMRC At Palmetto Bay
Palmetto Bay, Florida, 33157
New Horizons Research
Palmetto Bay, Florida, 33176
Best Choice Medical and Research Services
Pembroke Pines, Florida, 33024
Bolanos Clnical Research
Pembroke Pines, Florida, 33028
Mercado Medical Practice/CCT Research
Philadelphia, Pennsylvania, 19111
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85006
National Institute of Clinical Research, Inc.
Pomona, California, 91768
NextStage Clinical Research-Port Arthur/Gulf Coast Cardiology
Port Arthur, Texas, 77642
ActivMed Practices and Research
Portsmouth, New Hampshire, 03801
Praveen K Gupta, MD/Avacare
Rockville, Maryland, 20852
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
JAELEX Research
Round Lake Beach, Illinois, 60073
Synexus Clinical Research US; Inc.
San Antonio, Texas, 78229
Velocity Clinical Research, San Bernardino
San Bernardino, California, 92408
Velocity Clinical Research at Coastal Heart Medical Group
Santa Ana, California, 92704
Velocity Clinical Research of Santa Ana
Santa Ana, California, 92704
Axces Research Group
Santa Fe, New Mexico, 87505
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Velocity Clinical Research
Sioux City, Iowa, 51106
Velocity Clinical Research
Slidell, Louisiana, 70458
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
St. Louis Medical Professionals/CCT Research
St Louis, Missouri, 63119
Velocity Clinical Research (St. Louis)
St Louis, Missouri, 63131
Velocity Clinical Research, Suffolk, VA
Suffolk, Virginia, 23435
Olympus Clinical Research
Sugarland, Texas, 77479
Cordova Research Institute
Sweetwater, Florida, 33182
D&H Tamarac Research Center, LLC
Tamarac, Florida, 33321
Fiel Family & Sports Medicine CCT Research
Tempe, Arizona, 85283
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, 32162
Synexus Clinical Research US; Inc.
Tucson, Arizona, 85741
NextStage Clinical Research - Tulsa
Tulsa, Oklahoma, 74136
Velocity Clinical Research, Union
Union, South Carolina, 29379
Velocity Clinical Research
Valparaiso, Indiana, 46383
Velocity Clinical Research, Van Nuys
Van Nuys, California, 91405
Velocity Clinical Research
Vestal, New York, 13850
Waco Cardiology Consultants
Waco, Texas, 76712
Providere Research
West Covina, California, 91790
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
AMR Wichita West
Wichita, Kansas, 67205
AMR Wichita East
Wichita, Kansas, 67207
Wichita Surgical Specialists
Wichita, Kansas, 67214
About this study
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
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).
Read the 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.
- Conditions
- Obesity
- Being tested
- Naltrexone-Bupropion (NB) Combination, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone-Bupropion (NB) CombinationDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone/Bupropion (NB) | Active comparator | Patients will be randomly assigned to NB (naltrexone 8 mg and bupropion 90 mg) extended-release oral tablet. Receives: Drug: Naltrexone-Bupropion (NB) Combination |
| Placebo | Placebo comparator | Patients will be randomly assigned to placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Cardiovascular Death
Occurrence of cardiovascular death in number of study patients receiving NB compared with number of study patients receiving placebo.
Measured: Treatment initiation through 1 year following treatment termination.
Occurrence of Non-fatal Myocardial Infarction (MI)
Occurrence of MI in number of study patients receiving NB compared with number of study patients receiving placebo. MI will be identified using current standard diagnostic criteria, such as the 2017 Cardiovascular and Stroke Endpoints Definitions for Clinical Trials.
Measured: Treatment initiation through 1 year following treatment termination.
Occurrence of Non-fatal Stroke
Occurrence of non-fatal stroke in number of study patients receiving NB compared with number of study patients receiving placebo. Stroke will be identified using current standard diagnostic criteria, such as the 2017 Cardiovascular and Stroke Endpoints Definitions for Clinical Trials.
Measured: Treatment initiation through 1 year following treatment termination.
Secondary outcomes (3)
Comparative Rates of Cardiovascular Death
Comparative rates of cardiovascular death between number of study patients receiving NB compared to number of study patients receiving placebo.
Measured: Treatment initiation through 1 year following treatment termination.
Comparative Rates of Non-fatal Myocardial Infarction (MI)
Comparative rates of non-fatal MI between number of study patients receiving NB compared to number of study patients receiving placebo.
Measured: Treatment initiation through 1 year following treatment termination.
Comparative Rates of Non-fatal Stroke
Comparative rates of non-fatal stroke between number of study patients receiving NB compared to number of study patients receiving placebo.
Measured: Treatment initiation through 1 year following treatment termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start3 Jan 2024
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Currax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098079
- Sponsor's protocol ID
- NB-CVOT3
- Acronym
- INFORMUS
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06098079
- Acronym / sponsor ID
- INFORMUS / NB-CVOT3
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,600 participants (estimated)
- Lead sponsor
- Currax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone/Bupropion (NB) | Active comparator | Drug: Naltrexone-Bupropion (NB) CombinationPatients will be randomly assigned to NB (naltrexone 8 mg and bupropion 90 mg) extended-release oral tablet. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be randomly assigned to placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient age ≥18 years at screening
- 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
- 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)
- 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:
Key exclusion criteria (18 listed)
- Using prescription medications, other than Contrave/Mysimba, or surgical or medical device interventions for weight loss
- History of MI or stroke within 90 days prior to screening
- 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
- Meets any of the following criteria:
- Seizure disorders or history of seizures, not including subjects with a history of pediatric febrile seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone-Bupropion (NB) CombinationA 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 | Naltrexone/Bupropion (NB) |
| PlaceboA total daily dosage of two placebo tablets twice daily (in an identical, non-medicine containing tablet) is reached at the start of Week 4. | Drug | Placebo |
Primary outcome
Occurrence of Cardiovascular Death
Time frame: Treatment initiation through 1 year following treatment termination.
Occurrence of cardiovascular death in number of study patients receiving NB compared with number of study patients receiving placebo.
Occurrence of Non-fatal Myocardial Infarction (MI)
Time frame: Treatment initiation through 1 year following treatment termination.
Occurrence of MI in number of study patients receiving NB compared with number of study patients receiving placebo. MI will be identified using current standard diagnostic criteria, such as the 2017 Cardiovascular and Stroke Endpoints Definitions for Clinical Trials.
Occurrence of Non-fatal Stroke
Time frame: Treatment initiation through 1 year following treatment termination.
Occurrence of non-fatal stroke in number of study patients receiving NB compared with number of study patients receiving placebo. Stroke will be identified using current standard diagnostic criteria, such as the 2017 Cardiovascular and Stroke Endpoints Definitions for Clinical Trials.
3 secondary outcomes
Comparative Rates of Cardiovascular Death
Time frame: Treatment initiation through 1 year following treatment termination.
Comparative Rates of Non-fatal Myocardial Infarction (MI)
Time frame: Treatment initiation through 1 year following treatment termination.
Comparative Rates of Non-fatal Stroke
Time frame: Treatment initiation through 1 year following treatment termination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
140 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone-Bupropion (NB) Combination in people with Obesity, run by Currax Pharmaceuticals at 140 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 140 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Cardiovascular Death (time frame: Treatment initiation through 1 year following treatment termination.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.