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Naltrexone + Bupropion for Obesity (INFORMUS Trial)

Verified 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
Do you have a past history of any heart disease (i.e heart attack, cardiac stents, abnormal ekg )?
Have you struggled with being overweight?
Must not have
Have you experienced a heart attack or stroke within the last 90 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment initiation through 1 year following treatment termination.
Awards & highlights

Summary

This trial studies the effects of a medication combination (naltrexone and bupropion) on heart health. It targets patients to see if this treatment increases the risk of major heart problems. The study also includes advice on diet and exercise. Naltrexone and bupropion have been used in combination for weight loss, but they have been associated with various adverse effects, including neuropsychiatric disorders and cardiovascular risks.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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
~5733 spots leftby Jan 2029
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