A Study to Investigate Brenipatide Compared with Placebo in Adult Participants with Alcohol Use Disorder (RENEW-ALC-2)

The purpose of this research study is to learn more about brenipatide, a possible new investigational drug for the 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.

How long will this study take? 

This study will take about 68 weeks to complete.

What will happen if you join the study? 

During the study, some of the activities might happen at the University of Pennsylvania CSA (Center for Studies of Addiction), at your home, or at other places, depending on the study and local rules.

The study staff and doctor will explain the study to you, including:

• which treatments you can still use,
• how the study will be conducted and what you’ll need to do,

• and will answer any questions you have.

During the study, the study staff will need to take a small amount of blood from you for testing and safety monitoring purposes, and to measure the amount of study drug in your body. It is usually a few tubes of blood. This is similar to what is taken during a regular visit to your doctor.

During the study, you will need to write in a log when (and where on your body) you inject the study drug, and the log will be reviewed at each visit. You will need to return all study drug syringes, both unused and used, throughout the duration of the study to make sure you are taking your study drug as directed by your doctor.

If you or your sexual partner(s) can get pregnant, the following guidance applies:

• Birth control should be used during the study and for 8 weeks after receiving the last dose of study drug.
• Tell your study doctor right away if you or your sexual partner(s) become pregnant or plan to breastfeed. If you or your partner become pregnant, the study staff will collect information about the pregnancy, its outcome, and the health of the child after birth for up to 6 to 8 weeks beyond the estimated delivery date.
• The study doctor will review with you whether you may need to use birth control, which method of birth control is required while you are in the study.

• You may not donate sperm during the study and for 8 weeks after the last dose of the study drug.

The study happens in periods. The activities may be a little different in each period, described in the sections below.

Screening Period 

Screening Period

The first part of this study is the Screening Period. It lasts about 4 weeks depending on your personal health care situation. This period will help figure out whether you can continue to the next part of the study.

During this time, you will have some tests and activities, including:

• Medical and family history, including medicines, vitamins, and herbal supplements you take
• Vital signs like blood pressure and pulse rate
• Height, weight, and physical examination
• Blood draws and urine collection for laboratory tests, including screening for substance use
• Electrocardiogram (ECG) to check how your heart is working
• Questionnaires related to the study

• Diagnostic tests like eye exams (for participants with diabetes) 

During this time, you can expect about 1 blood draw and about 1 ECG, but you might need to have more. 

This period will help the study doctor figure out whether you can continue to the next part of the study.

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 the flip of 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.