Veru Completes PLATEAU Enrollment and Signs Novo Nordisk Clinical Supply Agreement for Enobosarm Combination Trial

With 239 patients enrolled and a clinical supply agreement with Novo Nordisk now in place, Veru Inc. has moved its Phase 2b PLATEAU trial into a new operational phase, one that will test whether enobosarm can meaningfully differentiate GLP-1 receptor agonist therapy by preserving lean mass and physical function during weight reduction in older patients.

The PLATEAU study is a double-blind, placebo-controlled trial evaluating enobosarm 3mg alongside semaglutide in patients aged 65 and older with a BMI of 35 or above. Veru exceeded its original 200-patient enrollment target, closing at 239 participants. The primary efficacy endpoint is percent change from baseline in total body weight at 68 weeks, with key secondary endpoints covering total fat mass, lean mass, stair climb performance, mobility disability, bone mineral density, HbA1c, and insulin resistance.

For clinical operations and supply chain leads, the Novo Nordisk agreement represents a notable structural choice: sourcing investigational semaglutide directly from the innovator rather than through a contract development and manufacturing organisation. That arrangement places supply continuity risk squarely within an innovator-to-innovator framework, a model that carries different quality oversight obligations than a traditional CMO relationship and warrants close attention in clinical supply planning for combination therapy programmes.

On the intellectual property side, Veru received a USPTO notice of allowance in August 2026 for a key U.S. patent covering enobosarm with semaglutide. Once issued, the patent is expected to provide protection until at least October 2044, a timeline that will factor into any future licensing or commercialisation discussions around the combination.

An interim analysis measuring lean body mass and fat mass by DXA scan at 32 weeks is expected in Q1 2027, with final topline data anticipated in Q4 2027. The interim readout will be the first quantitative signal on whether enobosarm's tissue-selective mechanism translates into a measurable lean mass advantage over semaglutide alone in this population.

The Q1 2027 interim analysis represents the next hard checkpoint for programme continuity, and its DXA-based lean mass data will carry significant weight in shaping the regulatory and commercial path forward for enobosarm as a GLP-1 combination agent.

Source: Veru Inc. via GlobeNewswire, 10 August 2026. Conference call and webcast hosted 8:00 a.m. ET, same date.