Naltrexone + Bupropion 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

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

Pivotal Trial

Drug Has Already Been Approved

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment initiation through 1 year following treatment termination.

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.