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ReclutamentoFASE3INTERVENTISTICO

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.

A colpo d'occhio

Stato
Reclutamento
Fase
FASE3
Sponsor
Eli Lilly and Company
Obiettivo di iscrizione
1,100
Inizio
16 Ott 2025
Completamento stimato
01 Apr 2028

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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).

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione 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).
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

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.

Locations (116)

  • Headlands Research - Scottsdale
    Codice postale verificato
    Scottsdale, Stati Uniti· Attivo ma non reclutante
  • Woodland International Research Group
    Codice postale verificato
    Little Rock, Stati Uniti· Attivo ma non reclutante
  • UCLA Clinical & Translational Research Center (CTRC)
    Codice postale verificato
    Los Angeles, Stati Uniti· Attivo ma non reclutante
  • Artemis Institute for Clinical Research
    Codice postale verificato
    Riverside, Stati Uniti· Attivo ma non reclutante
  • Artemis Institute for Clinical Research
    Codice postale verificato
    San Diego, Stati Uniti· Attivo ma non reclutante
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
    Codice postale verificato
    San Francisco, Stati Uniti· Attivo ma non reclutante
  • Accel Research Sites - Lakeland Clinical Research Unit
    Codice postale verificato
    Lakeland, United States· Attivo ma non reclutante
  • Innovative Clinical Research
    Codice postale verificato
    Lauderhill, United States· Attivo ma non reclutante
  • K2 Medical Research - Maitland
    Codice postale verificato
    Maitland, United States· Attivo ma non reclutante
  • K2 Medical Research ORLANDO
    Codice postale verificato
    Maitland, United States· Attivo ma non reclutante
  • Life Arc Research Centers - Miami
    Codice postale verificato
    Miami, Stati Uniti· Attivo ma non reclutante
  • Wellness Research Center
    Codice postale verificato
    Miami, Stati Uniti· Attivo ma non reclutante

Domande comuni

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.

Che cos'è 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.

Per quanto tempo sarò nello studio?

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.

Posso smettere di partecipare allo studio in qualsiasi momento?

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

Come saperne di più

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

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