The STAY study finishes enrollment: A big day for dog-kind!
It might seem like I’m always jazzed about something at Loyal, and truthfully I almost always am. Today’s update, however, is especially sensational for me — I’m so excited to share that we’ve completed enrollment for the STAY study. 1,300 dogs, across 70+ clinics nationwide. Wowee.
Now let’s rewind.
How we got here (and why LOY-002 needs STAY)
Picture this — it’s 2022 and Loyal is obsessed with our founding moonshot idea: bringing to market the first FDA-approved drug for lifespan extension in dogs. We’d already gotten a jump start — we were deep in the weeds on the science and our pipeline of drugs, had an amazing team, and an unwavering commitment to aging dogs and their owners. Our goal was in sharp focus. But a very large and pesky challenge loomed — designing and executing a clinical trial that could demonstrate lifespan extension.
Enter the STAY study, the 1,300-dog, 70-site pivotal effectiveness study for LOY-002, our drug for senior dogs. Executing this trial has been my northstar focus for the majority of my time with Loyal. Even after we designed the study and got the thumbs up from the FDA’s Center for Veterinary Medicine on our plan and agreement that a longevity drug could be approved if we met our endpoints (aka “concurrence”), we still had to be able to do it operationally.
So many questions kept me up at night. Could we enroll this many dogs? Would we even be able to find veterinary practices interested in participating? How would we convince practitioners that clinical research is something they could and should do? How would we get the long-term commitment this study would require?
Fast forward to July 2025.
I’m so elated to tell the world that we achieved full enrollment in the STAY study!
That means that, even when the odds were against us, our scrappy team at this biotech-turned-animal health-company overcame the odds and enrolled 1,300 dogs in a veterinary clinical trial. For dog lovers and veterinarians it means the possibility of an FDA-approved lifespan extension drug is just that much closer.
This study has screened over 1,500 dogs in order to enroll 1,300 eligible participants. We are so fortunate to have found such a devoted group of dog owners who want to be part of making a lifespan extension drug a reality and are willing to participate in this landmark field study.
We have 72 veterinary clinics participating across the United States. An unbelievable feat in veterinary clinical trials! Even more amazing is that nearly ¾ of those study sites have never participated in clinical trials before. To say this is an amazing accomplishment is an understatement. The amount of dedication and willingness to learn all that’s required to run a clinical trial at our study sites has been so fun to witness. Our partner vet clinics are the real MVPs of the STAY study. I’d love to call out a few of our top enrolling sites that really understood the assignment:
Barlow Trail Veterinary Clinic in Sandy, Oregon, has unbelievably enrolled 105 dogs.
Quakertown Veterinary Clinic in Quakertown, Pennsylvania, has enrolled an impressive 79 dogs.
Animal Hospital of Dauphin County in Harrisburg, Pennsylvania, rounding out the top three recruiting 58 dogs.
So what’s next for STAY?
Having STAY fully enrolled gives us an opportunity to plan for the continued execution of the years-long study and maintain focus on pursuing expanded conditional approval of LOY-002. We already anticipate that in a few years the STAY study will go from being an ongoing study to a completed source of learning and understanding about how dogs age. We can’t wait to learn all the study dogs have to teach us and share our lessons learned for the betterment of the industry while executing this big ol’ study.
What else is next for Loyal?
We’re continuing to work on an exciting pipeline of new drugs for aging in dogs. We have our sights set on drugs for large dogs, younger dogs, and maybe even smaller dogs one day. Each milestone we reach with LOY-002 and the STAY study puts us a little closer to kicking off clinical trials across our pipeline.
These are exciting times at Loyal (wait, don’t I always say that?). Follow along with us to watch our progress and continue to hype us as we still have our eye on the moonshot.