A Study to Investigate Brenipatide Compared with Placebo in Adult Participants with Moderateto- Severe Alcohol Use Disorder (RENEW-ALC-1)

The purpose of this research study is to learn more about brenipatide, a possible new investigational drug for the study treatment of alcohol use disorder. An investigational drug is one that has not been approved by the United States Food and Drug Administration (FDA).

Brenipatide is a GLP-1 agonist and is given by weekly injection.

About 1100 people will be in this study. 

The study aims to learn: 

• Whether it can help you reduce craving for alcohol, reduce alcohol consumption and maintain this.

• Whether it works better than a placebo (a placebo is an inactive or “pretend” study drug).

• Whether it is safe

• What are the possible side effects.

• Study Treatment Period 

• This period of the study lasts for about 56 weeks. This is when you get either brenipatide or placebo to compare how well they work. We refer to these all together as “study drug.”
• Neither you nor your study doctor will know which study drug you are getting. The likelihood that you will receive the drug being studied will depend on how the study is set up and is determined by chance (like flipping a coin). 

• There are 2 parts to this study. 

• The first part of the study lasts for about 32 weeks. The chance that you will get brenipatide is about 6 in 10.

• The second part of the study lasts for about 24 weeks. What you get in this part depends on what you received earlier: 

• If you got the placebo in the first part, you will get brenipatide now. 

• If you got brenipatide before, there is a 1 in 3 chance you will get the placebo this time.

• During this time: 

• You will take study drug for about 56 weeks by injection under your skin (sub-cutaneous injection).

  • Your dose will be increased after 4 weeks so that you will get the full regular dose or 

  • You will get the full dose.

  If you are having certain side effects during the study, your study doctor may choose to lower the dose of study drug that you are taking at that time. If you are already on the lowest dose of the study drug, you will receive the placebo.

  • You will have some tests/activities including: 

  • Vital signs like blood pressure, temperature, and pulse rate

  • Weight and physical examination

  • Blood draws and urine collection for laboratory tests, including screening for substance use 

  • Electrocardiogram (ECG)

  • Questionnaires related to the study

  • Training on signs, symptoms, and treatment of low blood sugar (for participants with diabetes) 

  • Training on nutritional needs 

  • Review what you eat and drink and help you get the nutrients you need 

  • Continue to self-inject weekly 

• During this time, you can expect about 18 blood draws and about 6 ECGs, but you might need to have more. Ask the study doctor if you want to know more.

• Follow-Up Period 

• After you have finished with the study treatment period and are no longer receiving study drug, the study doctor will continue to check on your health and you may be asked to have more tests. This is called the Follow-up Period, and it lasts for about 8 weeks. 

• During this time: 

• You will no longer receive study drug.

• You will have some tests/activities including:

  • Vital signs like blood pressure, temperature, respiratory rate, and pulse rate 

  • Weight, and brief physical examination

  • Blood draws for laboratory tests and urine collection, including screening for substance use

  • Electrocardiogram (ECG)

  • Questionnaires related to the study

• You can expect about 2 blood draws and about 1 ECG during the follow-up period, but you might need to have more. Ask the study doctor if you want to know more.