Ellen Ratcliff, DVM

Veterinarian pals, listen, I’ve been there. For the better part of two decades, I was a mixed animal practitioner working 80 hour weeks, on call 50% of my life, almost never (

) getting a day off. I was stressed out, overstretched, weary, and just trying to keep my head above water. At the same time I was also bored, fighting stagnancy, and wondering if this was my life from there on out. 

Enter a close veterinary friend who was working in-industry and trying to get me to run clinical studies in my practice. In spite of not feeling like I could add a single new thing to my to do list, and admittedly at least partly due to my inability to say no (

figuring when my head popped off at least I would get some rest in the hospital

That decision changed my practice life for the better, and just happened to also lead me in a new career direction I would have never even otherwise known about. While I am not suggesting everyone pursue a new career, I definitely think practicing veterinarians should consider some of the intangible reasons why participating in clinical trials just might be a good move. Yes, even you (

It can sometimes feel like the day-to-day grind of veterinary medicine is so far removed from your scientist side that you can’t even see it from there with binoculars. Yeah, we have microscopes and fecal samples and ELISA tests. But DOING science can seem like something from our college days. I started being an investigator in research, y’all – something I previously thought was only for academics. I can’t tell you how nice it was to be recognized as a scientist again. Animal health companies need your scientist brain and it makes a gal feel sharp to get to use it.

2. Be a part of something bigger than yourself.

I like being a member of a club or a group of people trying to do something I couldn’t do alone. This is probably why I’m also a veterinarian in the Army Reserve and why we all felt that inexplicable camaraderie in vet school. But in practice life, the stress of staff and clients can really be barriers to that feeling. When you start doing clinical studies in your practice, you become a small part of the mission of the company doing that research. You meet new people working towards that goal and you become an integral part of the team. 

3. Learn a new skill set and a new language.

Are you a whiz at talking about anal glands, atopy, and otitis while telling a technician what fluid rate to set the DKA dog on and asking the receptionist to tell the rat poison dog’s owner to come pick it up, all with one hand tied behind your back? You might be ready to learn a new competency in veterinary medicine. Doing something unfamiliar and stimulating that requires a cobwebby part of your brain feels like a breath of fresh air. The change in scenery on your appointment schedule can really reinvigorate the practice pro. New skills, novel processes, innovative medical care, unfamiliar ways of thinking about a problem you may or may not have even known existed? Fun! 

4. Gain a whole new appreciation for how approved drugs get onto your clinic shelves! 

Spoiler alert – it’s a wayyyy lengthier and more involved process than most of us have any concept about. Veterinary medicine has so few approved drugs compared to human medicine. It can only benefit our profession to have pharmacy shelves with more approved drugs that are extensively studied, found to be effective, but also safe. This just isn’t possible without practicing veterinarians participating in this process. 

Having an inside glance into Good Clinical Practice (GCP) studies and understanding how high the data quality must be and how our personal integrity and attention to detail as the investigator plays into that – pretty nifty. Also pretty cool is getting to use novel therapeutics before they even make it to the shelves. 

5. Novel revenue stream (ok, admittedly this one is tangible).

Doing clinical research in your clinic just might give you the chance to see fewer patients in an hour while making the same income. Or add a few more patients to your schedule and increase your income. That was certainly the case for me. It ended up being an unexpectedly lucrative venture for me as a clinical investigator and the work was interesting, diverse, engaging in a way that made it feel like I had stumbled upon a secret in veterinary medicine. 

It is a fruitful enough endeavor that many practices hire a veterinarian and support staff just to run clinical studies in their practices. Sometimes trial sponsors even help fund this. It can be a great way to grow a practice in a time when vets are losing constant inflow of revenue from online pharmacies and pandemics. 

This is my legit real world experience doing clinical studies as a busy general practitioner. I’d love to find out if any of you have similar experiences or wildly different involvement in this space. So let’s hear it, veterinary colleagues, anyone ready to hear how to dip their tired feet into this pool? 

Dr. Ellen Ratcliff, DVM, brings 17 years of mixed animal practice experience to Loyal as the Director of Clinical Development. She’s a Veterinary Corps Officer in the United States Army Reserve with a wealth of experience in public health and Military Working Dog care. Ellen previously managed clinical development at KindredBio, an animal pharmaceutical company. Ellen completed her DVM at the University of Missouri. She lives at home with her 3 beloved cats and her dog, Sormeh.

Clinical trials in the real world: One practitioner’s perspective

Veterinarian pals, listen, I’ve been there. For the better part of two decades, I was a mixed animal practitioner working 80 hour weeks, on call 50% of my life, almost never (literally never) getting a day off. I was stressed out, overstretched, weary, and just trying to keep my head above water. At the same time I was also bored, fighting stagnancy, and wondering if this was my life from there on out.&nbsp;



Enter a close veterinary friend who was working in-industry and trying to get me to run clinical studies in my practice. In spite of not feeling like I could add a single new thing to my to do list, and admittedly at least partly due to my inability to say no (sound familiar?), I consented to try it (figuring when my head popped off at least I would get some rest in the hospital).&nbsp;



That decision changed my practice life for the better, and just happened to also lead me in a new career direction I would have never even otherwise known about. While I am not suggesting everyone pursue a new career, I definitely think practicing veterinarians should consider some of the intangible reasons why participating in clinical trials just might be a good move. Yes, even you (especially you!) general practitioners.&nbsp;



1. Remember you’re a scientist!&nbsp;



It can sometimes feel like the day-to-day grind of veterinary medicine is so far removed from your scientist side that you can’t even see it from there with binoculars. Yeah, we have microscopes and fecal samples and ELISA tests. But DOING science can seem like something from our college days. I started being an investigator in research, y’all &#8211; something I previously thought was only for academics. I can’t tell you how nice it was to be recognized as a scientist again. Animal health companies need your scientist brain and it makes a gal feel sharp to get to use it.



2. Be a part of something bigger than yourself.



I like being a member of a club or a group of people trying to do something I couldn’t do alone. This is probably why I’m also a veterinarian in the Army Reserve and why we all felt that inexplicable camaraderie in vet school. But in practice life, the stress of staff and clients can really be barriers to that feeling. When you start doing clinical studies in your practice, you become a small part of the mission of the company doing that research. You meet new people working towards that goal and you become an integral part of the team.&nbsp;



3. Learn a new skill set and a new language.



Are you a whiz at talking about anal glands, atopy, and otitis while telling a technician what fluid rate to set the DKA dog on and asking the receptionist to tell the rat poison dog’s owner to come pick it up, all with one hand tied behind your back? You might be ready to learn a new competency in veterinary medicine. Doing something unfamiliar and stimulating that requires a cobwebby part of your brain feels like a breath of fresh air. The change in scenery on your appointment schedule can really reinvigorate the practice pro. New skills, novel processes, innovative medical care, unfamiliar ways of thinking about a problem you may or may not have even known existed? Fun!&nbsp;



4. Gain a whole new appreciation for how approved drugs get onto your clinic shelves!&nbsp;



Spoiler alert &#8211; it’s a wayyyy lengthier and more involved process than most of us have any concept about. Veterinary medicine has so few approved drugs compared to human medicine. It can only benefit our profession to have pharmacy shelves with more approved drugs that are extensively studied, found to be effective, but also safe. This just isn’t possible without practicing veterinarians participating in this process.&nbsp;



Having an inside glance into Good Clinical Practice (GCP) studies and understanding how high the data quality must be and how our personal integrity and attention to detail as the investigator plays into that &#8211; pretty nifty. Also pretty cool is getting to use novel therapeutics before they even make it to the shelves. Very cutting edge, right?



5. Novel revenue stream (ok, admittedly this one is tangible).



Doing clinical research in your clinic just might give you the chance to see fewer patients in an hour while making the same income. Or add a few more patients to your schedule and increase your income. That was certainly the case for me. It ended up being an unexpectedly lucrative venture for me as a clinical investigator and the work was interesting, diverse, engaging in a way that made it feel like I had stumbled upon a secret in veterinary medicine.&nbsp;



It is a fruitful enough endeavor that many practices hire a veterinarian and support staff just to run clinical studies in their practices. Sometimes trial sponsors even help fund this. It can be a great way to grow a practice in a time when vets are losing constant inflow of revenue from online pharmacies and pandemics.&nbsp;



This is my legit real world experience doing clinical studies as a busy general practitioner. I’d love to find out if any of you have similar experiences or wildly different involvement in this space. So let’s hear it, veterinary colleagues, anyone ready to hear how to dip their tired feet into this pool? <a href="mailto:ellen@loyalfordogs.com">Reach out via email</a> or <a href="https://loyalfordogs.com/for-vets/" data-type="URL" data-id="https://loyalfordogs.com/for-vets/">learn more</a> &#8211; I love to talk clinical trials.



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="686" height="452" src="https://blog-admin.loyalfordogs.com/wp-content/uploads/2022/08/dr-ellen-ratcliff-dvm-holding-black-dog-veterinary-medicine-2-1.jpg" alt="" class="wp-image-326" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2022/08/dr-ellen-ratcliff-dvm-holding-black-dog-veterinary-medicine-2-1.jpg 686w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2022/08/dr-ellen-ratcliff-dvm-holding-black-dog-veterinary-medicine-2-1-300x198.jpg 300w" sizes="(max-width: 686px) 100vw, 686px" /><figcaption>Dr. Ellen Ratcliff, DVM, brings 17 years of mixed animal practice experience to Loyal as the Director of Clinical Development. She’s a Veterinary Corps Officer in the United States Army Reserve with a wealth of experience in public health and Military Working Dog care. Ellen previously managed clinical development at KindredBio, an animal pharmaceutical company. Ellen completed her DVM at the University of Missouri. She lives at home with her 3 beloved cats and her dog, Sormeh.</figcaption></figure>

Jessica Austriaco

 is our pivotal efficacy study to demonstrate lifespan and healthspan extension in senior dogs treated with LOY-002. This is the biggest study of its kind ever conducted — we’re partnering with more than 50 independent veterinary clinics across the country.

These sites will enroll 1,000 senior dogs as part of this study. Here’s how to get your dog involved.

To participate in this study, your dog must meet several specific requirements. These requirements are necessary to ensure the scientific integrity of our study, so we’re not able to make any exceptions.

If you meet these requirements, your dog will undergo screening at a study site to confirm their eligibility.

The study will be conducted at 70 sites across the country. We’ll be opening these sites for enrollment in several phases over the coming months.

To see if we’re anticipating a site near you, review our 

. This map shows all planned sites for the STAY study, and displays contact details for sites that are currently open for enrollment.

If you don’t find a site near you, we encourage you to join the 

 for announcements on future studies and product availability.

Here are our upcoming sites, which will be updated with contact information in the site map when their clinic begins enrollment.

If there’s a site near you that’s open for enrollment, you can contact them directly at the address or phone number provided.

Let them know your dog’s age and weight and they’ll work with you to schedule a screening visit to determine your dog’s eligibility.

Enrolling your dog in the STAY study

The <a href="https://loyalfordogs.com/clinical-trials">STAY study</a> is our pivotal efficacy study to demonstrate lifespan and healthspan extension in senior dogs treated with LOY-002. This is the biggest study of its kind ever conducted — we’re partnering with more than 50 independent veterinary clinics across the country.



These sites will enroll 1,000 senior dogs as part of this study. Here’s how to get your dog involved.







<h2 class="wp-block-heading has-large-font-size">Eligibility</h2>



To participate in this study, your dog must meet several specific requirements. These requirements are necessary to ensure the scientific integrity of our study, so we’re not able to make any exceptions.



To enroll your dog:



<ol class="wp-block-list">
<li>They must be 10 years or older with proof of age. Acceptable documentation includes: breeding records or registrations, shelter adoption records for puppies less than six months old at the time of adoption, an examination by a veterinarian conducted when the dog was estimated to be one year old or younger, neutering records when the dog was estimated to be one year old or younger, other forms of verification that validate the dog’s age within a year, such as time-stamped puppy photos, photos that can be referenced with members of the family at a known age, or other time-specific documentation, at the discretion of the study investigator.</li>



<li>They must weigh at least 14 pounds.</li>



<li>You must be willing and able to participate for the full four-year duration of the study.</li>



<li>You must live near&nbsp;<a href="https://loyalfordogs.com/clinical-trials#participate" target="_blank" rel="noreferrer noopener">a study site</a>.</li>
</ol>



If you meet these requirements, your dog will undergo screening at a study site to confirm their eligibility.







<h2 class="wp-block-heading has-large-font-size">Sites open for enrollment</h2>



The study will be conducted at 55 sites across the country. We’ll be opening these sites for enrollment in several phases over the coming months.



To see if we’re anticipating a site near you, review our&nbsp;<a target="_blank" href="https://loyalfordogs.com/clinical-trials#participate" rel="noreferrer noopener">interactive site map</a>. This map shows all planned sites for the STAY study, and displays contact details for sites that are currently open for enrollment.



If you don’t find a site near you, we encourage you to join the&nbsp;<a href="https://loyalfordogs.com/#join" target="_blank" rel="noreferrer noopener">Loyal list</a>&nbsp;for announcements on future studies and product availability.



<h2 class="wp-block-heading has-large-font-size">Upcoming sites</h2>



Here are our upcoming sites, which will be updated with contact information in the site map when their clinic begins enrollment.



End of April



<ul class="wp-block-list">
<li>Folsom, Louisiana</li>



<li>Conyers, Georgia</li>
</ul>



End of May



<ul class="wp-block-list">
<li>Liverpool, New York</li>



<li>Midlothian, Virginia</li>



<li>Hendersonville, North Carolina</li>



<li>Columbia, South Carolina</li>



<li>Pensacola, Florida</li>



<li>Glenpool, Oklahoma</li>



<li>Bowie, Texas</li>



<li>Denver, Colorado</li>
</ul>



End of June



<ul class="wp-block-list">
<li>Waltham, Massachusetts</li>



<li>Chattanooga, Tennessee</li>



<li>Perkins, Oklahoma</li>



<li>Carrollton, Texas</li>



<li>Monument, Colorado</li>
</ul>



End of July



<ul class="wp-block-list">
<li>Virginia Beach, Virginia</li>
</ul>



This summer



<ul class="wp-block-list">
<li>Hoboken, New Jersey</li>



<li>Sandy Spring, Maryland</li>



<li>Starke, Florida</li>



<li>Land O’ Lakes, Florida</li>



<li>Quincy, Florida</li>



<li>Reedsburg, Wisconsin</li>



<li>Carbondale, Illinois</li>



<li>Batavia, Ohio</li>



<li>Nicholasville, Kentucky</li>



<li>Omaha, Nebraska</li>



<li>Lincoln, Nebraska</li>



<li>Papillion, Nebraska</li>



<li>Lindale, Texas</li>



<li>El Paso, Texas</li>



<li>Los Altos, California</li>



<li>Los Gatos, California</li>



<li>Norco, California</li>
</ul>



<h2 class="wp-block-heading has-large-font-size">How to get started</h2>



If there’s a site near you that’s open for enrollment, you can contact them directly at the address or phone number provided.



Let them know your dog’s age and weight and they’ll work with you to schedule a screening visit to determine your dog’s eligibility.



We’ll update our&nbsp;<a href="https://loyalfordogs.com/clinical-trials#map" target="_blank" rel="noreferrer noopener">site map</a>&nbsp;as new sites come online.

Celine Halioua

 about LOY-001 — our drug to extend healthy lifespan in large-breed dogs — prompted an incredible amount of press 

 at the Emmy awards. We’ve been touched by how enthusiastic the response has been to our work.

With LOY-001’s focus on large dogs, one of the most frequent questions I’ve received is, “Where is the love for small dogs?!” The answer is: it’s here!

In parallel to the LOY-001 injectable for large dogs (and its daily-pill counterpart, LOY-003) we’ve been developing LOY-002, a daily pill designed to extend healthy lifespan in senior dogs of all but the smallest sizes. 

Today, we’re announcing that we’ve dosed the first dog in our 

 — our pivotal efficacy study to demonstrate lifespan extension in senior dogs treated with LOY-002. To our knowledge, no one in animal health has ever run such a long and diverse study, and we’ve received interest from a flood of owners and dog lovers who want their dog to take part.

The STAY study name borrows from our WIRED cover story, where the highly apt ‘slogan’ was coined.

Meet Boo, the first dog dosed in our study

An energetic 11-year-old Whippet named Boo is the first participating dog to be dosed in this study. His owner Deb Hanna enrolled him at Animal Hospital of Dauphin County (AHDC) in Harrisburg, Pennsylvania, where Dr. Coby Rudakewiz is the STAY Principal Investigator.

Despite his age, Boo still competes in a dog sport called scent work — according to his owner he loves having something to do. 

“That’s one of the reasons I enrolled him,” said Deb. “It could help other dogs, including my younger dogs someday. It’s very important. I think anybody that has an older dog that could participate would jump at the chance.”

Boo, an 11-year-old Whippet, is the first dog dosed in our STAY study. He’s shown here with his owner Deb Hanna.

The STAY study will be conducted in partnership with more than 50 independent veterinary clinics like AHDC across the country, with over 1,000 pet dogs participating.

This is an unprecedented scale for a dog drug trial like this. For this study to definitively demonstrate that the LOY-002 extends healthy lifespan, we need sufficient diversity — breed, age, current health, behavior, geography, socioeconomics — among the study population.

Over 1,200 veterinarians have expressed interest in participating in STAY, in part because they respond to our mission to focus on the health of senior dogs.

“This was an easy decision,” said Dr. Rudakewiz. “At the AHDC, we are constantly looking for ways we can improve the way we care for pets and their health. The more avenues and tools we have to offer and educate owners on how to keep their dogs healthy, the more lives we can affect in a positive way.”

Dr. Coby Rudakewiz is the principal investigator for the STAY study at the Animal Hospital of Dauphin County in Harrisburg, PA.

Over the four-year span of STAY, we’ll collect data on the drug’s impact on the lifespan of dogs receiving LOY-002 compared to those receiving placebo. We are also collecting data on quality of life and frailty. We’ll share the results of the study with the FDA as part of our application for full approval to market the drug for lifespan extension.

In parallel we’re also pursuing conditional approval for LOY-002 based on our existing efficacy, safety and manufacturing data. The FDA Center for Veterinary Medicine’s expanded conditional approval pathway is an accelerated approval program designed for animal drugs that address an unmet medical need, but require long or complex studies to complete collection of definitive effectiveness data. 

If the FDA grants conditional approval for LOY-002, veterinarians will be able to prescribe the drug to qualified dogs as soon as early 2025 while the STAY study continues to gather the lifespan data required for full approval. We recently 

 LOY-001 earning efficacy approval under this same program.  

Our first cohort of study sites has already begun enrolling senior dogs, and we’ll be bringing other sites online in the coming months.

If your dog meets the study criteria and you’re interested in enrolling them, visit the 

STAY is a massive undertaking that wouldn’t be possible without the partnership of the many veterinary teams running the study in their clinics, and the dogs and owners participating across the country — including you, Boo.

Thank you all for helping us bring these therapies to dogs everywhere.

Meet Boo — the first dog dosed in our LOY-002 pivotal study for extending healthy lifespan in dogs of nearly all sizes

Our recent <a href="https://loyalfordogs.com/posts/loyal-announces-historic-fda-milestone-for-large-dog-lifespan-extension-drug">announcement</a> about LOY-001 — our drug to extend healthy lifespan in large-breed dogs — prompted an incredible amount of press <a href="https://www.youtube.com/watch?v=5yjxq42zEeI">coverage</a> and conversation, including a <a href="https://www.tiktok.com/@imdb/video/7324757406825663787?_r=1&amp;_t=8j6zMe8AHJT">shoutout</a> at the Emmy awards. We’ve been touched by how enthusiastic the response has been to our work.



With LOY-001’s focus on large dogs, one of the most frequent questions I’ve received is, “Where is the love for small dogs?!” The answer is: it’s here!



In parallel to the LOY-001 injectable for large dogs (and its daily-pill counterpart, LOY-003) we’ve been developing LOY-002, a daily pill designed to extend healthy lifespan in senior dogs of all but the smallest sizes.&nbsp;



Today, we’re announcing that we’ve dosed the first dog in our <a href="https://loyalfordogs.com/clinical-trials">STAY study</a> — our pivotal efficacy study to demonstrate lifespan extension in senior dogs treated with LOY-002. To our knowledge, no one in animal health has ever run such a long and diverse study, and we’ve received interest from a flood of owners and dog lovers who want their dog to take part.



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="676" src="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Wired-Stay-cover-where-the-STAY-study-name-originated-Celine-Halioua-Wolfie-1024x676.jpg" alt="" class="wp-image-1017" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Wired-Stay-cover-where-the-STAY-study-name-originated-Celine-Halioua-Wolfie-1024x676.jpg 1024w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Wired-Stay-cover-where-the-STAY-study-name-originated-Celine-Halioua-Wolfie-300x198.jpg 300w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Wired-Stay-cover-where-the-STAY-study-name-originated-Celine-Halioua-Wolfie-768x507.jpg 768w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Wired-Stay-cover-where-the-STAY-study-name-originated-Celine-Halioua-Wolfie-1536x1014.jpg 1536w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Wired-Stay-cover-where-the-STAY-study-name-originated-Celine-Halioua-Wolfie.jpg 1920w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">The STAY study name borrows from our WIRED cover story, where the highly apt ‘slogan’ was coined.</figcaption></figure>







<h2 class="wp-block-heading">Meet Boo, the first dog dosed in our study</h2>



An energetic 11-year-old Whippet named Boo is the first participating dog to be dosed in this study. His owner Deb Hanna enrolled him at Animal Hospital of Dauphin County (AHDC) in Harrisburg, Pennsylvania, where Dr. Coby Rudakewiz is the STAY Principal Investigator.



Despite his age, Boo still competes in a dog sport called scent work — according to his owner he loves having something to do.&nbsp;



“That’s one of the reasons I enrolled him,” said Deb. “It could help other dogs, including my younger dogs someday. It’s very important. I think anybody that has an older dog that could participate would jump at the chance.”



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="682" src="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Boo-and-Deb-—-2-1024x682.jpg" alt="Boo Hanna Whippet and STAY study participant with Loyal LOY-002 and his owner Deb Hanna" class="wp-image-1024" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Boo-and-Deb-—-2-1024x682.jpg 1024w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Boo-and-Deb-—-2-300x200.jpg 300w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Boo-and-Deb-—-2-768x512.jpg 768w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Boo-and-Deb-—-2-1536x1024.jpg 1536w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Boo-and-Deb-—-2.jpg 2000w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Boo, an 11-year-old Whippet, is the first dog dosed in our STAY study. He’s shown here with his owner Deb Hanna.</figcaption></figure>



<h2 class="wp-block-heading">The largest study of its kind</h2>



The STAY study will be conducted in partnership with more than 50 independent veterinary clinics like AHDC across the country, with over 1,000 pet dogs participating.



This is an unprecedented scale for a dog drug trial like this. For this study to definitively demonstrate that the LOY-002 extends healthy lifespan, we need sufficient diversity — breed, age, current health, behavior, geography, socioeconomics — among the study population.



Over 1,200 veterinarians have expressed interest in participating in STAY, in part because they respond to our mission to focus on the health of senior dogs.



“This was an easy decision,” said Dr. Rudakewiz. “At the AHDC, we are constantly looking for ways we can improve the way we care for pets and their health. The more avenues and tools we have to offer and educate owners on how to keep their dogs healthy, the more lives we can affect in a positive way.”



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="682" src="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Dr.-Rudakewiz-—-2-1024x682.jpg" alt="Dr Coby Rudakewiz Veterinarian DVM Animal Hospital of Dauphin County Harrisburg PA Pennsylvania Principle Investigator" class="wp-image-1026" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Dr.-Rudakewiz-—-2-1024x682.jpg 1024w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Dr.-Rudakewiz-—-2-300x200.jpg 300w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Dr.-Rudakewiz-—-2-768x512.jpg 768w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Dr.-Rudakewiz-—-2-1536x1024.jpg 1536w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/01/Dr.-Rudakewiz-—-2.jpg 2000w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Dr. Coby Rudakewiz is the principal investigator for the STAY study at the Animal Hospital of Dauphin County in Harrisburg, PA.</figcaption></figure>



Over the four-year span of STAY, we’ll collect data on the drug’s impact on the lifespan of dogs receiving LOY-002 compared to those receiving placebo. We are also collecting data on quality of life and frailty. We’ll share the results of the study with the FDA as part of our application for full approval to market the drug for lifespan extension.







<h2 class="wp-block-heading">When will LOY-002 be available?</h2>



In parallel we’re also pursuing conditional approval for LOY-002 based on our existing efficacy, safety and manufacturing data. The FDA Center for Veterinary Medicine’s expanded conditional approval pathway is an accelerated approval program designed for animal drugs that address an unmet medical need, but require long or complex studies to complete collection of definitive effectiveness data.&nbsp;



If the FDA grants conditional approval for LOY-002, veterinarians will be able to prescribe the drug to qualified dogs as soon as early 2025 while the STAY study continues to gather the lifespan data required for full approval. We recently <a href="https://loyalfordogs.com/posts/loyal-announces-historic-fda-milestone-for-large-dog-lifespan-extension-drug">announced</a> LOY-001 earning efficacy approval under this same program.&nbsp;&nbsp;







<h2 class="wp-block-heading">Enrolling your dog in STAY</h2>



Our first cohort of study sites has already begun enrolling senior dogs, and we’ll be bringing other sites online in the coming months.



If your dog meets the study criteria and you’re interested in enrolling them, visit the <a href="https://loyalfordogs.com/clinical-trials">STAY page</a> to look for sites near you.







<h2 class="wp-block-heading">Thank you to our partners</h2>



STAY is a massive undertaking that wouldn’t be possible without the partnership of the many veterinary teams running the study in their clinics, and the dogs and owners participating across the country — including you, Boo.



Thank you all for helping us bring these therapies to dogs everywhere.