RENEW-Op: A Study to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Buprenorphine with or without Naloxone in Early Recovery of Participants with Opioid Use Disorder
Sponsored by Eli Lilly and Company
Study Basics
RENEW-Op-1 is a study for people who are ready to stop using or misusing opioids. To join, you must be taking a buprenorphine medication (e.g., Suboxone, Subutex). You will keep taking this medication during the study. You will also get weekly injections of a GLP-1 investigational drug (Brenipatide).
Study Purpose
The purpose of this study is to learn more about brenipatide, a possible new investigational drug to help people stop using opioids. 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.
This study aims to learn:
- What are the possible side effects.
- Whether it can help reduce craving and opioid use when used with buprenorphine.
How long will this study take?
The length of the study depends on when you join:
- Everyone will be in the study for at least 1 year and 4 months.
- If you join the study early, you may be in the study for up to 2 years and 3 months.
But always remember, you can leave the study at any time and without giving any reason.
What does the study involve?
Investigational drug comes in a prefilled syringe. To take it, you will give yourself an injection under your skin. If you prefer, your study team can do the injections for you.
This study has 3 main parts:
- Screening
- Between 2 weeks and 1 month, 2 visits
- Check if the study is right for you
- Between 2 weeks and 1 month, 2 visits
- Open-label
- At least 1 year and 1 month, 45 visits or more
- Take the investigational drug as an injection
- Continues until everyone gets the investigational drug for at least 1 year and 1 month
- If you join early, you may be in this part for up to 2 years (57 visits)
- At least 1 year and 1 month, 45 visits or more
- Safety follow-up
- 2 months after the last injection, 2 visits
- Final study health and safety checks
Could this study be right for you?
To join, you must meet these criteria:
- Aged 18 to 75 years old
- Have opioid use disorder
- Taking a buprenorphine medication for between 2 months and a year
- Sometimes using or misusing opioids like heroin, fentanyl, or prescription opioids
- Body mass index (BMI) of at least 22
You will also need to meet other criteria to join. The study team will provide more details
You will be compensated for participating in the study.
Contact the Research Team if you are interested in participating
Learn More about CLinical trials at Eli lilly and company
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
Tricia Wright, MD, MS
Sub-Investigator
Professor, 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.
Kim Fernandez, BS
Assistant Clinical Research Coordinator
Kim Fernandez is an Assistant Clinical Research Coordinator with a background in serving people with people who use substances. She has an understanding of vulnerable patient populations and is eager to learn and grow as an research coordinator.
Sierra Brandts, BS
Clinical Research Coordinator
Sierra Brandts is a Clinical Research Coordinator with experience in neurophysiology from the University of the South.