Toutes les études
RecrutementPHASE3INTERVENTIONNEL

A Study of Brenipatide in Participants With Alcohol Use Disorder

This research study is investigating a new potential treatment, brenipatide, for individuals who have alcohol use disorder (AUD) and drink at hazardous levels. The main goal is to find out if brenipatide is both safe to use and effective in helping people reduce or stop drinking, compared to a placebo (a dummy treatment). Participants will be involved in the study for about 56 weeks, which is just over a year. Throughout this time, researchers will closely monitor their health and drinking habits to understand how well the new medication works and if there are any side effects. Your participation would help us learn more about potential new ways to treat AUD.

En un coup d'œil

Statut
Recrutement
Phase
PHASE3
Sponsor
Eli Lilly et Compagnie
Objectif d'inscription
1,100
Démarrer
16 oct. 2025
Achèvement estimé
01 Avr 2028

De quoi parle cette étude ?

This study is all about finding a new and effective way to help people who are struggling with alcohol use disorder, sometimes called AUD. AUD is a medical condition where a person has problems controlling their drinking, is preoccupied with alcohol, or continues to use alcohol even when it causes problems. The new medication being tested in this study is called brenipatide.

Researchers want to compare brenipatide to a placebo. A placebo looks just like the actual medication but doesn't contain any active drug. This comparison helps scientists understand if any changes seen are truly due to brenipatide or if they might happen anyway. It's a standard and important part of medical research to make sure new treatments are genuinely effective.

By taking part, you would be contributing to vital research that could one day lead to more options for people living with alcohol use disorder. The study will look carefully at whether brenipatide helps people reduce or stop their drinking and if it's safe to use over time.

Points clés

  • The study tests a new drug, brenipatide, for alcohol use disorder.
  • It compares brenipatide to a placebo (dummy treatment).
  • Participation lasts about 56 weeks (over a year).
  • You'll need to self-inject the medication or have help.
  • Close medical monitoring and regular visits are part of the study.
  • Your involvement helps advance treatments for alcohol use disorder.

Qui peut être éligible ?

To join this study, you need to be between 18 and 75 years old. If you're in Japan, you need to be at least 20. It's important that you are actively looking for help with your drinking and are motivated to either stop or cut down.

You can't take part if you've recently had problems with other drug use (apart from nicotine or caffeine) within the last six months. Also, if you've had certain thoughts about self-harm or suicide recently, or have a history of serious liver disease related to alcohol, this study might not be suitable for you. You also shouldn't have taken part in another drug study within a certain recent timeframe.

Overall, the study is looking for people who are committed to attending appointments, willing to follow instructions, and can manage self-injecting the study medication (or have someone to help them).

Cet étude pourrait-elle vous convenir ?

Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.

  1. Are you between 18 and 75 years old (or 20+ if in Japan)?
  2. Are you motivated to stop or cut down your drinking?
  3. Can you commit to around 56 weeks for the study?
  4. Will you be able to give yourself injections or have someone help you?
  5. Do you have certain serious liver conditions or recent drug use issues (excluding nicotine/caffeine)? (If yes to these, you might not be eligible).
  6. Have you recently had specific thoughts about self-harm or suicide? (If yes, you might not be eligible).
Répondez à chaque question pour voir votre résultat.

En quoi consiste la participation ?

If you join this study, your involvement will last for about 56 weeks, which is just over a year. During this time, you would have regular visits to the study clinic where you'll have health checks and discussions about your progress. You will also need to self-inject the study medication – either brenipatide or the placebo – at home. If you're unable to do this yourself, someone trained can help you.

You'll also be asked to keep track of your information in diaries, either on paper or electronically, and complete questionnaires. These help the researchers understand how you're feeling and how the treatment is working. Throughout the study, your health will be carefully monitored to check for any side effects and to see the effects of the treatment.

Risques et avantages potentiels

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help with your alcohol use disorder, and close medical monitoring. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not be effective for you. You will also receive either brenipatide or a placebo, and will not know which one. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Emplacements (116)

  • Headlands Research - Scottsdale
    Code postal vérifié
    Scottsdale, États-Unis· Actif, mais pas en recrutement
  • Woodland International Research Group
    Code postal vérifié
    Little Rock, États-Unis· Actif, mais pas en recrutement
  • UCLA Clinical & Translational Research Center (CTRC)
    Code postal vérifié
    Los Angeles, États-Unis· Actif, mais pas en recrutement
  • Artemis Institute for Clinical Research
    Code postal vérifié
    Riverside, United States· Actif, mais pas en recrutement
  • Artemis Institute for Clinical Research
    Code postal vérifié
    San Diego, États-Unis· Actif, mais pas en recrutement
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
    Code postal vérifié
    San Francisco, États-Unis· Actif, mais pas en recrutement
  • Accel Research Sites - Lakeland Clinical Research Unit
    Code postal vérifié
    Lakeland, États-Unis· Actif, mais pas en recrutement
  • Innovative Clinical Research
    Code postal vérifié
    Lauderhill, United States· Actif, mais pas en recrutement
  • K2 Medical Research - Maitland
    Code postal vérifié
    Maitland, United States· Actif, mais pas en recrutement
  • K2 Medical Research ORLANDO
    Code postal vérifié
    Maitland, United States· Actif, mais pas en recrutement
  • Life Arc Research Centers - Miami
    Code postal vérifié
    Miami, États-Unis· Actif, mais pas en recrutement
  • Wellness Research Center
    Code postal vérifié
    Miami, États-Unis· Actif, mais pas en recrutement

Questions fréquentes

What is brenipatide?

Brenipatide is a new medication being tested to see if it can help people with alcohol use disorder reduce or stop their drinking.

Qu'est-ce qu'un placebo ?

A placebo is a 'dummy' treatment that looks just like the real medication but doesn't contain any active drug. It helps researchers compare the new treatment's effects.

Combien de temps vais-je participer à l'étude ?

If you join, you will be part of the study for about 56 weeks, which is roughly one year and two months.

Will I know if I'm getting the real medication or the placebo?

No, you won't know if you're receiving brenipatide or the placebo. This is to ensure fair results for the study.

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point and for any reason, without it affecting your regular medical care.

Comment en savoir plus

Questions sur les essais ou questions de participation : 1-877-CTLILLY (1-877-285-4559) ou

Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.

Intéressé à participer ?

Inscrivez votre intérêt

Partagez vos coordonnées et l'équipe de recherche pour "A Study of Brenipatide in Participants With Alcohol Use Diso… vous contactera si vous êtes éligible. Consultez toujours votre médecin avant d'accepter de participer.

Discussion

Discussion communautaire

Propulsé par notre forum à community.patient.info. Veuillez être respectueux — ceci n'est pas un avis médical.