J&J launches a second phase 2 trial of GLP-1/glucagon dual agonist, this time in patients with severe obesity + type 2 diabetes – July 25, 2018

J&J recently posted a new phase 2 study for its GLP-1/glucagon dual agonist candidate to The dose-ranging study (n=188) will assess once-weekly JNJ-64565111 in patients with severe obesity (BMI 35-50 kg/m2) and type 2 diabetes. Co-primary endpoints will measure (i) weight loss over 12 weeks; and (ii) frequency of adverse events. The trial is expected to complete by March 2019.

It’s notable that the primary endpoint of this study is focused on treating obesity, despite the type 2 diabetes inclusion criteria. This follows another phase 2 trial of JNJ-64565111 (launched in April, also expected to complete in March 2019) in patients with severe obesity but without type 2 diabetes, and it confirms our sense that J&J is first and foremost targeting an obesity indication for its GLP-1/glucagon dual agonist. Secondary outcomes in the new study include proportion of patients achieving ≥5% weight loss from baseline.

The competitive landscape of GLP-1/glucagon dual agonists is certainly robust, and we note that this emerging therapy class has possible implications in obesity, diabetes, and NASH. Sanofi has completed phase 2 trials of its GLP-1/glucagon candidate and is focused on obesity (although management recently alluded to some unforeseen tolerability issues, leaving us uncertain about the timeline for phase 3). OPKO Health is also targeting an obesity indication, while AZ has a development program ongoing for its GLP-1/glucagon dual agonist in NASH.

J&J is certainly not alone in this competitive landscape, but we see plenty of room for multiple products in this class to be successful, if/when they are brought to market. In fact, several thought leaders have suggested that GLP-1/glucagon represents the next stride forward in GLP-1 therapy, and GLP-1 mono-agonists are among the most advanced diabetes drugs available today.  

As background, J&J licensed JNJ-64565111 (previously known as HM12525A) from Korea-based Hanmi Pharmaceuticals in 2015, and completed phase 1 studies that year. Positive phase 1 data on the candidate was presented at ADA 2015.


--by Martin Kurian, Payal Marathe, and Kelly Close