Ozempic®, Wegovy®, or Toujeo® – these names are nearly impossible to miss today, even for those without a professional connection to diabetes therapy. What many may not realize is that Profil has played a significant role in the development of numerous medications that now help millions of people worldwide.
Since our founding in 1999, we have conducted more than 600 clinical studies, including around 535 Phase I and II trials. For many of today’s approved diabetes medications, we were already involved in the crucial early stages of development, contributing significantly to modern diabetes therapy.
A particularly prominent example is Ozempic® (semaglutide, a GLP-1 receptor agonist), developed by Novo Nordisk and approved for the treatment of type 2 diabetes. This drug is groundbreaking because it not only reliably lowers blood glucose but also enables significant and sustained weight loss – even in people without diabetes who are affected by obesity. While Ozempic® is only approved for diabetes treatment, its higher-dosed version, Wegovy®, is used specifically for weight reduction in individuals with overweight and obesity. It gained worldwide attention partly because public figures such as Elon Musk and Kim Kardashian shared their experiences, creating a genuine lifestyle phenomenon (in 2022 alone, semaglutide was prescribed to 13.5 million people in the United States).
Other companies have developed similar therapies: Eli Lilly, for example, introduced Trulicity® (dulaglutide), Saxenda® (liraglutide), and Mounjaro® (tirzepatide).
Our Role
Profil has conducted numerous studies on GLP-1 receptor agonists over the years – initially in populations with diabetes, later also in individuals with obesity without diabetes. Our first study with a GLP-1 analogue began in 2003. In early phases, hypoglycemia was common, so hypo-kits were prepared during trials. Today, gastrointestinal side effects such as nausea are more prevalent, which is why emesis basins and antiemetics are now a common sight in everyday clinical practice.
These studies revealed the key mechanisms of action: increased insulin secretion, reduced glucagon release, delayed gastric emptying, and enhanced satiety signaling. Many of these effects were identified by us at an early stage – some, such as reduced appetite, were initially even recorded as an adverse events. Ironically, these early observations have become one of the main reasons patients now take the medication. These findings laid the foundation for subsequent studies by Novo Nordisk and Eli Lilly, leading to approval in the US in 2017 and in the EU in 2018.
But our impact does not end with GLP-1 agents: Numerous insulins have also been tested with us in early clinical phases, including insulin aspart (Novo Nordisk), Humalog® (Eli Lilly), Toujeo® (Sanofi), and the once-weekly insulin Awiqly® (also Novo Nordisk). In addition, we play a decisive role in the approval of biosimilars in the EU: For all of the biosimilars approved to date, the required studies were conducted with our involvement.
Beyond that, we have also contributed to studies on Jardiance® (Boehringer Ingelheim) — an SGLT-2 inhibitor that is used today not only for diabetes but also for heart failure.
Why we do it
Profil’s co-founder Dr. Tim Heise established the institute with a clear mission: to make a meaningful contribution to the treatment of diabetes and obesity – a principle that remains central to our vision today.
This motivation is shared by our CEO, Prof. Leona Plum-Mörschel, who moved from basic research into clinical trials: “Laboratory work and experimental models are exciting — but often far removed from clinical reality. At Profil, we work closer to the end product, closer to people, and closer to the outcome: improving the health and quality of life of individuals with diabetes and obesity. I wanted research that goes beyond generating knowledge and offers concrete solutions to real-world problems,” she says in describing her decision.
The results of this work are embodied in medications that help millions of people with diabetes manage daily life and support individuals with obesity in achieving sustainable weight loss, improving their quality of life. Worldwide, around 537 million people live with type 2 diabetes, a number expected to rise to 783 million by 2045 (IDF). Profil’s research is not just about innovation – it is about tangible impact.
How we do it
Profil mainly conducts early-phase clinical studies (Phase I and II), a critical stage in drug development. While Phase III trials involve thousands of patients to evaluate efficacy and safety under near-real-world conditions, early-phase studies with typically 30 to 300 participants provide the essential data needed to design these larger trials efficiently.
These studies answer fundamental questions: Is the treatment safe? What dose is most effective and well tolerated? How does the drug act in the body? Which population benefits most? How can subsequent trials be optimized? Solid early-phase data ensures that large-scale studies are well designed, unpromising candidates are stopped early, costs are reduced, and patients are spared unnecessary burden. Without these early studies, many approved drugs would either not exist or would have reached patients much later.
Why it all matters
Every study we conduct is a step toward better therapies – and sometimes even a breakthrough. Our work does not end at the trial site; it creates ripple effects that change lives around the world. Whether it is a new insulin, an innovative GLP-1 therapy, or an entirely new drug class, Profil is involved at the stage where laboratory ideas prove their potential to help millions.
Profil is not just part of the process; it is a pivotal contributor to the story behind many drugs that now save, extend, or improve lives worldwide. In this way, our studies ensure that scientific insights do not remain in the lab but are transformed into real solutions for real people.
Want to learn more about our research activities? Find our publications here.