Plus: a note on the use of non-FDA approved Peptides in our practice.
If you have been hearing about the new “GLP-1 pills” or the new cholesterol medication Lipfendra (enlicitide), you may have some questions about how we are utilizing these within the Bale Doneen Method.
The field of cardiometabolic medicine is changing rapidly! While we have had an excellent toolbox of injectable GLP-1 receptor agonists and PCSK-9 inhibitors (like Repatha and Pralulent), new FDA-approved oral medications are expanding our toolbox to address obesity, insulin resistance, cholesterol and cardiovascular risk with less cost prohibitive medications.
GLP-1 Medications: Targeting more Than Weight Loss
GLP-1 receptor agonist medications mimic hormones involved in blood sugar regulation, appetite, digestion and metabolism. They improve insulin signaling, reduce inappropriate glucagon release, slow stomach emptying and increase satiety (fullness). The result can be improved glucose control, reduced insulin resistance and weight loss.
However, we do not use these medications simply as weight-loss drugs; rather, they are used to treat cardiometabolic risk. Insulin resistance, obesity, high blood pressure, abnormal cholesterol, fatty liver disease and inflammation frequently occur together as part of the broader context of cardiometabolic disease. There is growing, consistent evidence that GLP-1 therapies reduce cardiovascular events.
For example, injectable semaglutide and tirzepatide both carry an FDA indication to reduce the risk of cardiovascular death, heart attack and stroke. Our approach is low-dose pharmaceutical therapy, monitored regularly with full body DEXA Scanning to ensure muscle mass is maintained and visceral (dangerous) fat is reduced.
What Is Different About the Oral Versions?
Several GLP-1 options are now available as tablets, including oral semaglutide and the newer oral GLP-1 medication orforglipron (Foundayo). Foundayo was FDA-approved in 2026.
The major difference is convenience: a pill instead of an injection. However, oral does not necessarily mean better. Each medication has differences in dosing, absorption, side effects, effectiveness, cost and insurance coverage. As always, we work with you to determine which approach makes the most sense for each individual patient.
An Oral PCSK9 Inhibitor
Lipfendra (enlicitide) represents another significant advance in the changing landscape of advanced cholesterol management. PCSK9 inhibitors help the liver to remove LDL cholesterol from the bloodstream. In the landmark clinical trial for the drug, Lipfendra lowered LDL cholesterol by 56% in the treatment group versus a 3% increase in the placebo group. Until now, this class of medications has only been available as an injectable (Repatha & Pralulent). Lipfendra is the first FDA-approved oral PCSK9 inhibitor and is taken once daily. PCSK9 inhibitors further reduce cardiovascular risk when added to statin therapy.
For individuals who require substantial LDL reduction beyond standard statin therapy (those at high risk or intolerant to statins), having an effective oral option makes intensive cholesterol management easier, less expensive and more acceptable to some individuals who are fearful of self-injections. While Lipfendra is an attractive option for those already on injectable PCSK9 inhibitors, it is important to note that the medication does not yet have long-term outcome data; though the assumption is that outcome data will mirror that of the injectable form.
The field of cardiometabolic health and cardiovascular disease prevention is constantly shifting and changing as we gain more insight into the interconnectedness between things like blood sugar, blood pressure, lipids, inflammation and the development of arterial disease. This change is exciting, and with many new treatment options on the horizon, we are keeping up to date with the research and will help you to navigate any changes to your treatment plan.
A Note on Peptides:
When you trust us with your health, we take that responsibility seriously. We know that you have many options — and often a lot of information coming at you online — when it comes to wellness. Our commitment is to help you navigate those choices with honesty, transparency and your long-term health in mind. That means we sometimes choose not to offer treatments that are popular or heavily promoted, even when there is significant public interest in them.
In our practice, we believe every treatment we recommend should meet a high standard for safety, quality, and scientific evidence. That’s why we do not currently recommend or prescribe peptides that have not been approved by the U.S. Food and Drug Administration (FDA). FDA approval means a medication has undergone a rigorous review of available evidence regarding its safety, effectiveness, quality, manufacturing and labeling. When any compound (or peptide) has not gone through that process for a particular use, there may be important unanswered questions about its purity, consistency, dosing, potential side effects, drug interactions and long-term safety.
We understand that non-FDA-approved peptides have been widely discussed online and may be promoted for weight loss, muscle building, anti-aging or other health goals. However, enthusiasm and testimonials are not a substitute for high-quality clinical evidence. Our responsibility is to recommend treatments based on the best available evidence, not on trends or marketing. We will continue to evaluate emerging therapies as the science develops, and when a treatment meets appropriate standards for safety, efficacy and regulatory approval, we can consider incorporating it into our practice. Our goal is simple: to provide care that is thoughtful, evidence-based and worthy of your trust.
