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Naltrexone/Bupropion (NB) for Obesity (INFORMUS Trial)

Phase 4
Recruiting
Research Sponsored by Currax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Angina with ischemic changes (resting echocardiogram (ECHO), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment initiation through 1 year following treatment termination.
Awards & highlights

INFORMUS Trial Summary

This trial aims to study the effects of naltrexone/bupropion (NB) on cardiovascular outcomes in real-world conditions. It will be a randomized, double-blinded, and placebo-controlled

Who is the study for?
This trial is for adults over 18 with obesity or overweight with conditions like hypertension, type 2 diabetes, or dyslipidemia. Participants must have a history of heart issues but stable for at least 90 days and not currently on other weight loss medications. They should understand the study and consent to participate.Check my eligibility
What is being tested?
The study tests if a combination drug (Naltrexone-Bupropion) affects major cardiovascular events compared to a placebo. It's randomized and double-blinded, meaning participants are put into groups by chance without knowing which treatment they receive.See study design
What are the potential side effects?
Possible side effects include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. There may also be an increased risk of seizures and elevated blood pressure.

INFORMUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chest pain with signs of heart strain on tests.
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I am overweight or obese and have a condition like high blood pressure, type 2 diabetes, or high cholesterol.
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I am on medication for high cholesterol.
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I am 18 years old or older.

INFORMUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment initiation through 1 year following treatment termination.
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment initiation through 1 year following treatment termination. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Cardiovascular Death
Occurrence of Non-fatal Myocardial Infarction (MI)
Occurrence of Non-fatal Stroke
Secondary outcome measures
Comparative Rates of Cardiovascular Death
Comparative Rates of Non-fatal Myocardial Infarction (MI)
Comparative Rates of Non-fatal Stroke

INFORMUS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Naltrexone/Bupropion (NB)Active Control1 Intervention
Patients will be randomly assigned to NB (naltrexone 8 mg and bupropion 90 mg) extended-release oral tablet.
Group II: PlaceboPlacebo Group1 Intervention
Patients will be randomly assigned to placebo.

Find a Location

Who is running the clinical trial?

Currax PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
68,353 Total Patients Enrolled
2 Trials studying Obesity
67,970 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently being accepted for this ongoing medical study?

"As per the information available on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was originally posted on January 3rd, 2024 and has been recently updated on January 8th, 2024."

Answered by AI

What is the current size of the patient cohort being observed in this clinical investigation?

"Affirmative. The data available on clinicaltrials.gov indicates that this clinical trial is currently in the recruitment phase. Initially posted on January 3rd, 2024, it was last amended on January 8th, 2024. This study aims to enroll a total of 8,400 patients from two designated sites."

Answered by AI

Has the combination of Naltrexone and Bupropion (NB) received official authorization from the FDA?

"Considering that this trial is classified as Phase 4, indicating the approval of Naltrexone/Bupropion (NB) for treatment, our team at Power rates its safety with a score of 3."

Answered by AI

Who else is applying?

What site did they apply to?
Velocity Clinical Research
Velocity Clinical Research, Gardena
Velocity Clinical Research, Phoenix
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I need to lose weight. i've tried every diet under the sun. I need to loose weight to be considered for kidney tx.
PatientReceived 1 prior treatment
I've tried several options and have not had consistent long lasting results.
PatientReceived 2+ prior treatments
I have attempted to lose this weight with all sorts of diets and approaches without success.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
2024. "Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06098079.
All > Paid Studies Las Vegas > Madison
~5733 spots leftby Jan 2029
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