GZMI
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEWMDD-2)
IRAS ID
1013874
Contact name
Emily Coss
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
This study is testing whether a new medicine called brenipatide can help prevent the return of major depressive disorder (MDD) — a serious condition causing persistent low mood, loss of interest, and other symptoms that significantly affect daily life. Even with existing antidepressant treatments, many people with depression experience a return of symptoms (called a "relapse"). There are currently no medicines approved specifically to prevent relapse when added on top of standard antidepressant therapy. Brenipatide works differently from existing antidepressants — it targets the body's metabolic and inflammatory systems, which emerging research suggests play a role in depression. Adults aged 18–75 who have had three or more depressive episodes in their lifetime, are currently in remission (or near remission) on a stable antidepressant, and have a body mass index (BMI) of at least 22.
Participants first complete a 4-week screening period. Those who qualify are then randomly assigned to receive either brenipatide (at one of three doses) or a placebo — all given as a weekly injection under the skin, alongside their usual antidepressant. Neither participants nor study staff know which treatment is being received. Participants are followed until they experience a relapse or the study ends, with a minimum of 12 months of treatment. After stopping, there are two further follow-up visits over approximately 8 weeks.
The main outcome is how long it takes for depression symptoms to return. Secondary outcomes include changes in body weight, mood symptoms, anxiety, quality of life, and daily functioning.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
26/NE/0092
Date of REC Opinion
18 Jun 2026
REC opinion
Further Information Favourable Opinion