RENEW-ALC: A Study to Investigate Brenipatide Compared with Placebo in Adult Participants with Alcohol Use Disorder
Sponsored by Eli Lilly and Company
Study Basics
Are you seeking to change your relationship with alcohol? The RENEW-ALC studies will test how safely and well the investigational medicine works for people with alcohol use disorder. These studies will include people with all levels of alcohol use disorder. This includes those with mild (RENEW-ALC-2) and moderate or severe (RENEW-ALC-1) alcohol use disorder. A person's level of alcohol use disorder is related to how many symptoms they have and how those symptoms affect their life.
The investigational medicine being tested in these studies may reduce how much alcohol someone drinks, by potentially lowering the desire to drink it.
Study Purpose
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.
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
The study team is investigating if Low-Intensity Focused Ultrasound (LIFU) can be used to suppress cravings in alcohol use disorder.
How long will this study take?
This study will last about 1 year and 4 months.
What does the study involve?
If you would like to take part in one of these studies, the study doctor will do some health checks and ask you questions to make sure that is right for you. If you join a study, you will be randomly assigned (that is, by chance) to the investigational medicine or placebo group. You will give yourself an injection once a week using a prefilled syringe. Investigational medicine means it is still being tested in clinical research studies. A placebo looks the same as the investigational medicine but does not contain any medicine in it.
During the study you will attend visits with doctors and researchers either in person at a clinic or by phone or videocall. Participants who can get pregnant may need to use birth control.
Could this study be right for you?
Eligible participants are:
- Age 18 to 75 years
- Looking for treatment and are motivated to stop or cut down on drinking
- A female who had 10 or more drinks each week for the last month, or a male who had 20 or more drinks each week for the last month
The study team will discuss additional criteria with you before the study starts
renew-alc-1 ClinicalTrials.gov
RENEW-alc-2 ClinicalTrials.gov
Contact the Research Team if you are interested in participating
UCSF Study Personnel
Khaled Moussawi, MD, PhD
Principal Investigator
Associate Professor in Residence in the departments of Neurology and Psychiatry at UCSF with extensive experience in substance use disorders and neuromodulation. Dr. Moussawi is board-certified by the American Board of Psychiatry and Neurology.
Andy Tompkins, MD, MHS
Sub-Investigator
Director, Division of Substance Abuse and Addiction Medicine at Zuckerberg San Francisco General Hospital
Catherine Borror, BS, CCRP
Senior Clinical Research Coordinator
Catherine Borror is a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA) with experience in study design and coordination at UCSF working in the Neurology Department.
Sierra Brandts, BS
Clinical Research Coordinator
Sierra Brandts is a Clinical Research Coordinator with experience in neurophysiology from the University of the South.
Ananya Madhusudhan
Clinical Research Coordinator
Ananya Madhusudhan is a Clinical Research Coordinator with experience in Biomedical Engineering from Northeastern University.