GLP-1 (glucagon-like peptide-1) drugs have shown impressive potential not just in managing diabetes and obesity, but in treating or preventing certain diseases. But it’s not always been smooth-sailing for pharmaceutical companies and researchers. Let’s take a look at some key clinical trials involving GLP-1.
Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes
One of the major GLP-1 clinical trials was sponsored by Novo Nordisk and it involved over 17,600 participants. The data and findings were presented at the American Heart Association meeting and published in the New England Journal of Medicine. This study focused on patients at high risk for cardiovascular events, such as heart attacks and strokes, but who did not have diabetes. The trial aimed to assess the impact of semaglutide compared to a placebo for a period of three years.
The participants were predominantly white (84%) with a mean age of 62 and a mean BMI of over 33 kg/m². Nearly 70% had previously suffered a heart attack, while the rest had conditions like stroke or peripheral arterial disease. The study found that semaglutide reduced major cardiovascular events by 20%, and also significantly decreased the progression to diabetes, with only 3.5% of participants developing diabetes. This trial also highlighted the drug’s ability to reduce inflammation, with the participants’ lab results showing a big drop in C-reactive protein levels.
Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity
Another groundbreaking trial studied the effects of orforglipron, a daily oral GLP-1 receptor agonist, on patients who were overweight or obese but do not have diabetes. This randomized trial (double blind study) included 272 participants who were given different doses of orforglipron or a placebo in a period of 36 weeks.
Results showed that orforglipron led to significant weight loss (8.6% to 14.7% of body weight) compared to the placebo group (2.3%). Also a substantial portion of participants (46% to 75%) achieved at least a 10% weight reduction by week 36. The researchers also found that the safety profile of orforglipron was consistent with other GLP-1 receptor agonists.
Semaglutide in Obesity and Heart Failure
In August 2023, a trial involving 529 individuals with obesity and heart failure showed that semaglutide could markedly improve heart function. Study participants who were given semaglutide showed nearly double the improvement in heart function compared to those on a placebo. Also, another trial published in November 2023, which included over 17,000 people with excess weight and cardiovascular disease, found that semaglutide reduced the risk of heart attacks and strokes by 20%.
Walgreens and Boehringer’s Clinical Trial for Survodutide
Walgreens has partnered with German drugmaker Boehringer and Denmark’s Zealand Pharma to conduct a Phase III trial of survodutide, a new GLP-1 drug.
Survodutide has already passed initial safety and efficacy trials and is now being compared against existing treatments in this final phase. If successful, Boehringer will seek FDA approval, making survodutide a key competitor to current GLP-1 drugs like Wegovy, Ozempic and Mounjaro. This trial highlights the growing demand for GLP-1 drugs, which have proven effective in aiding weight loss and managing cardiometabolic conditions.
Researchers are now exploring the use of GLP-1 drugs for other conditions such as drug addictions, Alzheimer’s, and Parkinson’s diseases, pointing to a broader scope of benefits beyond their initial indications.