Brenipatide for Opioid Use Disorder

(RENEW-Op-1 Trial)

This trial tests a new treatment called brenipatide to determine its safety and effectiveness for individuals with opioid use disorder (OUD) who are already taking buprenorphine, with or without naloxone. Participants will receive either brenipatide or a placebo (a substance with no active drug) while continuing their current buprenorphine treatment. Suitable candidates for this trial have OUD, occasionally use non-prescribed opioids, and are committed to attending regular study visits and following study procedures, such as keeping a diary and self-injecting the study drug. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications, but you must be taking buprenorphine for opioid use disorder to participate.

Research is investigating the safety of brenipatide when combined with buprenorphine for treating opioid use disorder. Earlier studies have tested various doses of brenipatide (0.3 mg, 0.75 mg, and 1.5 mg once a week) to assess tolerability. Although specific results from these studies are not available, the ongoing trial indicates potential safety.

Most treatments for opioid use disorder, like methadone and standard buprenorphine, work by reducing withdrawal symptoms and cravings, but Brenipatide offers a new approach. Researchers are excited because Brenipatide is administered subcutaneously and may work synergistically with buprenorphine, potentially enhancing its effectiveness. Additionally, Brenipatide has a novel mechanism of action that might address opioid addiction more comprehensively than current therapies. This could mean better outcomes for patients struggling with opioid use disorder.

Research has shown that brenipatide, when combined with buprenorphine, is under study for its potential to treat opioid use disorder. In this trial, participants will receive varying doses of brenipatide with buprenorphine, or a placebo with buprenorphine, to assess the effectiveness of these combinations. Buprenorphine alone helps reduce withdrawal symptoms and cravings, aiding individuals in staying off opioids. The combination aims to enhance these effects, potentially improving treatment outcomes. Early studies suggest that this combination could be safe and might outperform buprenorphine alone.¹²⁴⁵⁶