Lilly registers Phase 3 depression trial; posts results for two psoriasis and oncology studies

This week's Lilly-linked registry activity includes one new Phase 3 trial registration and results postings for three completed or ongoing studies across dermatology and oncology.

• A new Phase 3 trial of brenipatide (LY3537031) for major depressive disorder, called "RENEW-MDD-2," is not yet recruiting. The study is randomized, double-blind, and parallel-arm, with an estimated enrollment of 1000 participants.¹ Its primary outcome is time to relapse, defined as the number of days from randomization to the date on which a participant meets any relapse criterion of major depressive disorder¹, tracked over at least 12 months.
• Results were posted for a completed Phase 2 trial of LY4100511 (DC-853), an oral drug sponsored by DICE Therapeutics, a Lilly subsidiary, in moderate-to-severe plaque psoriasis. The trial enrolled 222 participants² and its primary outcome was the percentage of participants achieving at least a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 without use of background antipsoriasis therapy².
• Results were posted for a completed Phase I/II trial combining ramucirumab and pembrolizumab in recurrent or metastatic head and neck squamous cell carcinoma, sponsored by Washington University School of Medicine with Eli Lilly as a collaborator. The trial enrolled 43 participants³, and the Phase II primary outcome was objective response rate, measured through completion of treatment with a median follow-up of 162 days³.
• Results were posted for the completed MiST Phase IIa mesothelioma trial, sponsored by the University of Leicester with Eli Lilly among several collaborators. The trial enrolled 186 participants⁴ and included an abemaciclib arm for p16INK4A-negative disease, with a primary outcome of disease control rate at 12 weeks assessed by modified RECIST 1.1 in patients with relapsed mesothelioma⁴.