New drugs are drawing attention after studies have shown that they lead to dramatic weight loss in people with type 2 diabetes and a significant reduction in A1C (mean blood glucose).
Called tyrzepatide and marketed as Munjaro, the drug was approved by the US Food and Drug Administration (FDA) on May 13, 2022 as a new class of drug for patients with type 2 diabetes. It also has potential as a treatment for obesity in people without diabetes. Many people who manage and treat type 2 diabetes hear more about their prospects from a scientific session at the American Diabetes Association (ADA), the organization’s annual meeting, June 3-7, 2022. waiting.
“I was very excited to hear that this was approved,” said Robert Gabbay, MD, PhD, ADA’s Chief Science and Health Officer in Arlington, Virginia. “At this time of last year, at our science session, the research was presented and at the same time. New England Journal of Medicine That led to approval. Currently, making tyrzepatide available to both clinicians and patients is, to some extent, a bit of a struggle to get this kind of benefit. “
Weekly injections aren’t available yet, but pharmaceutical company Eli Lilly plans to start injections in the coming weeks.
Maggie Pfeiffer, Associate Director of Lily Diabetes Communications, says Munjaro’s list price is $ 974 for a four-week prescription for all doses. “Each individual insurance company and plan determines Munjaro’s out-of-pocket costs,” Pfeiffer said, adding that some people qualify for savings cards to reduce their out-of-pocket costs.
The most common side effects of tilzepatide are nausea and diarrhea, and people with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 should not take tilzepatide.
Dr. Gabey talked about the drug and explained how it works, important findings from clinical trials, and what to ask a doctor if a patient is interested in tyrzepatide.
Daily Health: How Does Tirzepatide Work to Reduce A1C and Weight in the Body?
Robert Gabey: It mimics the effects of two different hormones in the body. One is GLP-1, and there are drugs that do it in the last few years, especially. A new part of this drug is that it also has the effect of a second hormone called GIP (Stomach Inhibitor Polypeptide). Therefore, there are two hormonal effects.
It helps to affect A1C and weight in many ways.
When your blood sugar is high, your body releases excess insulin, but not so much, so your blood sugar doesn’t get too low. It slows the stomach from emptying, which allows a person to feel more full, eat less, and lose weight. It also affects the feeling of hunger and fullness in the brain (a signal that tells you when to stop eating) and loses weight. Therefore, it is all these combinations that improve blood sugar and lose weight.
EH: Who is eligible to take tilzepatide? Also, at what point on your diabetic journey? For example, after they have been diagnosed or after taking metformin?
RG: That’s a good question. It’s just available, so we’re literally organizing some of it. This week’s ADA Scientific Sessions will focus on that very issue.
It can be potentially used at various points in the journey of people who need both A1C loss and weight gain. And I think the dramatic thing about this medicine is that it can have a big impact on your weight. This is more powerful than the other options normally available. There is a very special opportunity.
EH: How long has it been studied and how rigorously has it been? What are some of the important discoveries that patients need to know?
RG: The way a drug is approved and approved by the FDA is through a series of studies to determine safety and dosage. Then they do a large study to determine if it is better than the current treatment (and they do a variety of them). Each study has a safety factor.
So, it is now being studied by a significant number of people, and as a result, it turns out that they lose a lot of weight. In a study published in ADA Scientific Sessions, people without diabetes lost 20% of their body weight. In the study, people lost an average of 52 pounds at the highest dose of tilzepatide, which is a lot.
EH: Do you guess that tyrzepatide could be used as a weight loss drug in people without diabetes?
RG: Indeed, it will be announced at the conference. We look forward to seeing the data in more detail. Please look forward to these results.
EH: What are your findings regarding diabetic remission?
RG: Diabetic remission indicates blood glucose levels in the non-diabetic range in the absence of medical or medication for 3 months. This is another exciting piece of data from this treatment. It’s really dramatic, as in one trial, people in the early stages of diabetes used tyrzepatide and 50% of those treated were in remission. It gives us the opportunity to think more realistically about remission as a goal in the treatment of type 2 diabetes.
EH: How is tyrzepatide compared to the diabetes treatments currently on the market?
RG: It differs considerably in some respects. This is the first drug to have the effects of these two hormones. Therefore, the behavior is different. There are not many direct studies of tyrzepatide with other drugs. However, from what they have suggested, weight loss seems to be more important than current treatments.
Obesity surgery is the only treatment that really rivals tyrzepatide for weight loss. It seems to be more powerful than the other medicines we have on the market. Over time, more direct tests will be done to prove it more clearly.
EH: With new medicines, we may not be able to know about the safety and efficacy of the general public. What do you see as a potential risk?
RG: We know that the main side effect is nausea. Therefore, the dose increases slowly and not everyone tolerates the highest dose. That is the limiting factor. Just as current GLP-1 medicines are not suitable for everyone, tyrzepatide is not suitable for everyone. What we already know, and as it is used in a wider population, we will understand it better-what percentage of people can tolerate it, or not.
One of the big open questions is that we don’t know if tyrzepatide has all the benefits of other GLP-1 drugs in reducing cardiovascular and kidney disease. Early data presented at ADA Scientific Sessions suggest that kidneys have benefits, which is encouraging. Stay tuned for ongoing research into potential cardiovascular benefits.
EH: What should patients think about the weight loss achieved by tyrzepatide in several clinical trials?
RG: First, the important message is that people should not be stigmatized for their weight. Weight loss is challenging. Obesity is a disease. We are developing better treatments. This is one potential treatment for obesity associated with diabetes. It has promising results.
Maybe we need to rethink what the treatment of obesity looks like in a diabetic situation. If someone needs treatment, they need treatment.
EH: What else should patients know about this drug?
RG: As we explained, it does not unhook the hook of doing good for our health in terms of controlling the quantity and quality of the food we eat and doing physical activity. They are still important. The goal is to run them, potentially augment them and use medicines to make you more successful.
EH: Black adults may have less participation in tyrzepatide clinical trials than white adults. And black adults are more likely to have diabetes than white adults. What do you think this means for the efficacy of the drug in that population?
RG: What the ADA has actually worked on with the FDA is to improve the diversity of clinical trial participants. This is not just the case for the tyrzepatide test. Looking at all diabetes drug and device trials, black, indigenous, and colored (BIPOC) communities have very low participation rates, and these individuals are more adversely affected or at risk of diabetes. It does not represent the fact that there is. We look forward to progress in this area and have strongly supported it.
EH: Can tyrzepatide be combined with other medicines?
RG: Yes, it seems that it can be combined with standard diabetes drugs that are not GLP-1 drugs, but we need more data to ensure. It will be interesting to see.
EH: What questions do patients need to ask their doctor about tyrzepatide?
RG: Am I eligible for this medicine? It’s important to ask your provider what the drawbacks and side effects are. It’s true whenever you start something new. Discuss with your healthcare provider to determine if it is suitable for you.
Obesity is a fundamental problem for most people with type 2 diabetes, so this new treatment is a potential game changer.
Editor’s Note: Answers have been edited for clarity and brevity.
Disclosure: Gabbay has disclosed that it participates in the advisory boards of Lark, Health Reveal, Vida Health, Onduo, and Sweetech.