Trial Outcomes & Findings for Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.) (NCT NCT06090461)
NCT ID: NCT06090461
Last Updated: 2025-06-25
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
31889 participants
Primary outcome timeframe
Up to 113 months
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12475
|
12171
|
7243
|
|
Overall Study
COMPLETED
|
12475
|
12171
|
7243
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
Baseline characteristics by cohort
| Measure |
Contrave/Mysimba
n=12475 Participants
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
n=12171 Participants
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=7243 Participants
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.
|
Total
n=31889 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
47.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 1.38 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
82.3 Percentage
n=5 Participants
|
81.8 Percentage
n=7 Participants
|
65.6 Percentage
n=5 Participants
|
77 Percentage
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
17.7 Percentage
n=5 Participants
|
18.2 Percentage
n=7 Participants
|
34.4 Percentage
n=5 Participants
|
23 Percentage
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
6.3 Percentage of participants
n=5 Participants
|
7.2 Percentage of participants
n=7 Participants
|
5.9 Percentage of participants
n=5 Participants
|
6 Percentage of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
68.3 Percentage of participants
n=5 Participants
|
69.2 Percentage of participants
n=7 Participants
|
65.7 Percentage of participants
n=5 Participants
|
68 Percentage of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
25.3 Percentage of participants
n=5 Participants
|
23.5 Percentage of participants
n=7 Participants
|
28.3 Percentage of participants
n=5 Participants
|
26 Percentage of participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 113 monthsThe 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.
Outcome measures
| Measure |
Contrave/Mysimba
n=12475 Participants
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
n=12171 Participants
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=7243 Participants
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.
|
|---|---|---|---|
|
The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.
AMI
|
26 Events
|
36 Events
|
10 Events
|
|
The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.
Stroke
|
6 Events
|
5 Events
|
5 Events
|
|
The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.
Death
|
0 Events
|
0 Events
|
1 Events
|
Adverse Events
Contrave/Mysimba
Serious events: 63 serious events
Other events: 0 other events
Deaths: 0 deaths
Lorcaserin
Serious events: 81 serious events
Other events: 0 other events
Deaths: 0 deaths
Naltrexone and Bupropion (N&B)
Serious events: 31 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Contrave/Mysimba
n=12475 participants at risk
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
n=12171 participants at risk
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=7243 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
AMI
|
0.21%
26/12475 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
0.30%
36/12171 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
0.14%
10/7243 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
|
Cardiac disorders
Stroke
|
0.05%
6/12475 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
0.04%
5/12171 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
0.07%
5/7243 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
|
Cardiac disorders
MACE
|
0.25%
31/12475 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
0.33%
40/12171 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
0.22%
16/7243 • Up to 113 months
For this study using previously collected and deidentified electronic healthcare data, the research team did not anticipate any new adverse events to be identified.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place