ObesityHOANCT06090461
Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
An observational study of Obesity, run by Currax Pharmaceuticals at 1 site in United States.
Trial summary
The fixed-dose combination of naltrexone 8mg and bupropion 90mg extended-release oral tablet is marketed under the trade name CONTRAVE® in the U.S. In this protocol, the investigators propose to generate real-world evidence (RWE) from electronic health records (EHR) and linked claims data to assess the cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- Type of treatment
- Pill or oral medicine
- How many people
- 31,889 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The primary study population includes initiators of NB or the active comparator, lorcaserin.
For the main objective (1.0, 1.1), patients are eligible if they meet the following Inclusion Criteria:
- Have at least one prescription for NB between September 2014 and February 2020, including concurrent prescriptions (within 15 days) for naltrexone and bupropion; or have at least one prescription for lorcaserin;
- Have at least 180 days of data available prior to cohort entry with no evidence of prescriptions or dispensings of NB or lorcaserin;
- Have at least one BMI value available in the 180 days prior to cohort entry, inclusive of the index date;
- Have documentation of at least one outpatient medical visit 180 or more days prior to cohort entry, and at least one healthcare interaction in the 180 days prior to cohort entry;
- Are at least 18 years of age on the cohort entry date.
For the main objective, patients are not eligible if they have a diagnosis of any of the following conditions in the 180 days before the cohort entry date:
- Epilepsy;
- Bulimia;
- Anorexia nervosa;
- Surgical procedure for weight loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Interventional Study to Generate Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
The fixed-dose combination of naltrexone 8mg and bupropion 90mg extended-release oral tablet is marketed under the trade name CONTRAVE® in the U.S. In this protocol, the investigators propose to generate real-world evidence (RWE) from electronic health records (EHR) and linked claims data to assess the cardiovascular safety of CONTRAVE® and all combined use of naltrexone and bupropion (NB) in usual clinical practice.
Read the detailed description
The study will assess whether patients who initiate treatment with NB are at an elevated risk of MACE compared with patients who initiated treatment with lorcaserin, an active comparator chosen to reduce potential confounding.
The cohorts for all study objectives will be drawn from a large electronic health records (EHR) data source, representing a geographically diverse patient population. The data will include diagnoses, procedures, medications (prescribed and administered), clinical measures (biometric and laboratory values), and observations derived from clinical notes. A subset of the population will have linked, adjudicated claims data available to support sensitivity analyses.
The study's main objective is to compare the incidence of the primary endpoint (MACE) between initiators of NB and initiators of lorcaserin. The study will also compare the incidence of the secondary endpoint, consisting of each component of MACE, between initiators of NB and initiators of lorcaserin, across the following subgroups: Patients with obesity (i.e., most recent BMI measurement ≥30 kg/m2); Patients with a diagnosis of hypertension, regardless of BMI; Patients with a diagnosis of type 2 diabetes mellitus, regardless of BMI; Patients with a diagnosis of dyslipidemia, regardless of BMI.
The study's additional objectives aimed at testing the robustness of the methods are:
To assess the comparability of findings from an EHR study to those of a 2018 clinical trial, aligning with the Randomized Control Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) Initiative; To quantify differences in cardiovascular safety endpoints between the clinical trial and the results of this EHR study; To conduct other sensitivity analyses, including a self-controlled, case-crossover analysis to quantify the potential effect of NB on MACE.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Contrave/Mysimba | A fixed-dose combination of 8 milligrams (mg) of naltrexone hydrochloride (HCl) (an opioid receptor antagonist), and 90 mg of bupropion HCl (a selective neuronal re-uptake inhibitor of noradrenaline and dopamine), delivered through extended-release oral tablets. | |
| Lorcaserin | A total of one 10 mg tablet administered orally twice daily; or one 20 mg tablet administered orally once daily. Lorcaserin was included as an active comparator to reduce bias. | |
| Naltrexone and Bupropion (N&B) | N\&B concomitant use, ultimately as a proxy for initiation, was defined as a record for naltrexone followed by initiation of bupropion, or bupropion followed by initiation of naltrexone, within 15 days of each other. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.
The primary study endpoint is MACE, defined as the composite of:
- Medically attended non-fatal acute myocardial infarction (AMI);
- Medically attended non-fatal stroke;
- Cardiovascular death.
Measured: Up to 113 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startSep 2014
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31,889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Currax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090461
- Sponsor's protocol ID
- Cardiovascular Safety Study
- Acronym
- HOA
- Status last verified
- Jun 2025
- First submitted
- 12 Oct 2023
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kyle M, Burns D, Murray CR, Watson H, Swaney J, Spevack S, Leonhard M, Simon M, Moynihan E, Lapane KL, Wang SV, Longo CL, Ritchey ME, Dore DD. Cardiovascular safety of fixed-dose extended-release naltrexone/bupropion in clinical practice. Obes Pillars. 2025 Feb 17;13:100169. doi: 10.1016/j.obpill.2025.100169. eCollection 2025 Mar.
PubMed 40104005
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study to Generate Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
- ClinicalTrials.gov ID
- NCT06090461
- Acronym / sponsor ID
- HOA / Cardiovascular Safety Study
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,889 participants (actual)
- Lead sponsor
- Currax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The fixed-dose combination of naltrexone 8mg and bupropion 90mg extended-release oral tablet is marketed under the trade name CONTRAVE® in the U.S. In this protocol, the investigators propose to generate real-world evidence (RWE) from electronic health records (EHR) and linked claims data to assess the cardiovascular safety of CONTRAVE® and all combined use of naltrexone and bupropion (NB) in usual clinical practice.
Detailed description
The study will assess whether patients who initiate treatment with NB are at an elevated risk of MACE compared with patients who initiated treatment with lorcaserin, an active comparator chosen to reduce potential confounding.
The cohorts for all study objectives will be drawn from a large electronic health records (EHR) data source, representing a geographically diverse patient population. The data will include diagnoses, procedures, medications (prescribed and administered), clinical measures (biometric and laboratory values), and observations derived from clinical notes. A subset of the population will have linked, adjudicated claims data available to support sensitivity analyses.
The study's main objective is to compare the incidence of the primary endpoint (MACE) between initiators of NB and initiators of lorcaserin. The study will also compare the incidence of the secondary endpoint, consisting of each component of MACE, between initiators of NB and initiators of lorcaserin, across the following subgroups: Patients with obesity (i.e., most recent BMI measurement ≥30 kg/m2); Patients with a diagnosis of hypertension, regardless of BMI; Patients with a diagnosis of type 2 diabetes mellitus, regardless of BMI; Patients with a diagnosis of dyslipidemia, regardless of BMI.
The study's additional objectives aimed at testing the robustness of the methods are:
To assess the comparability of findings from an EHR study to those of a 2018 clinical trial, aligning with the Randomized Control Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) Initiative; To quantify differences in cardiovascular safety endpoints between the clinical trial and the results of this EHR study; To conduct other sensitivity analyses, including a self-controlled, case-crossover analysis to quantify the potential effect of NB on MACE.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contrave/Mysimba | – | –A fixed-dose combination of 8 milligrams (mg) of naltrexone hydrochloride (HCl) (an opioid receptor antagonist), and 90 mg of bupropion HCl (a selective neuronal re-uptake inhibitor of noradrenaline and dopamine), delivered through extended-release oral tablets. |
| Lorcaserin | – | –A total of one 10 mg tablet administered orally twice daily; or one 20 mg tablet administered orally once daily. Lorcaserin was included as an active comparator to reduce bias. |
| Naltrexone and Bupropion (N&B) | – | –N\&B concomitant use, ultimately as a proxy for initiation, was defined as a record for naltrexone followed by initiation of bupropion, or bupropion followed by initiation of naltrexone, within 15 days of each other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary study population includes initiators of NB or the active comparator, lorcaserin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.
Time frame: Up to 113 months
The primary study endpoint is MACE, defined as the composite of: * Medically attended non-fatal acute myocardial infarction (AMI); * Medically attended non-fatal stroke; * Cardiovascular death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40104005Kyle M, Burns D, Murray CR, Watson H, Swaney J, Spevack S, Leonhard M, Simon M, Moynihan E, Lapane KL, Wang SV, Longo CL, Ritchey ME, Dore DD. Cardiovascular safety of fixed-dose extended-release naltrexone/bupropion in clinical practice. Obes Pillars. 2025 Feb 17;13:100169. doi: 10.1016/j.obpill.2025.100169. eCollection 2025 Mar.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Currax Pharmaceuticals at 1 site 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?
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: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin. (time frame: Up to 113 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090461, which also lists 1 linked publication.
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 25 Jun 2025.