Also known as: LY3537031
Brenipatide (LY-3537031) is a dual GLP-1 and GIP receptor agonist under development by Eli Lilly. It is being studied across addiction, psychiatric, respiratory, metabolic, and obesity-related indications with monthly subcutaneous dosing. The candidate remains investigational and has not been approved.
Eli Lilly has launched two Phase 2 trials for brenipatide (LY3537031): RENEW-Op-1 for opioid use disorder and RENEW-Scz-1 for schizophrenia. Both are randomized, double-blind, placebo-controlled studies that are not yet recruiting as of February 2026.
Eli Lilly launched the monthly Zepbound KwikPen for obesity treatment and initiated a Phase 2 trial for opioid use disorder, while Gilead Sciences agreed to acquire Arcellx for $7.8 billion to expand its cell therapy portfolio.
Eli Lilly is developing multiple next-generation obesity treatments, including oral GLP-1 drug orforglipron expected to launch in Q2 2026, as competition intensifies in a market projected to reach $95 billion by 2030.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07476118 |
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity |
RECRUITING | PHASE1 |
| NCT07420283 |
A Study of Brenipatide in Participants With Opioid Use Disorder |
RECRUITING | PHASE2 |
| NCT07412756 |
A Study of Brenipatide in Adult Participants With Major Depressive Disorder |
RECRUITING | PHASE3 |
| NCT07410507 |
A Study of Brenipatide in Adult Participants With Schizophrenia |
RECRUITING | PHASE2 |
| NCT07286175 |
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) |
RECRUITING | PHASE2 |
| NCT07223840 |
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse |
RECRUITING | PHASE2 |
| NCT07219173 |
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma |
RECRUITING | PHASE2 |
