Ep. 30 - Oral GLP 1 Is Here - What It Means for Weight Loss

Dr. Tim Sayed takes a closer look at the latest shift in medically supervised weight loss with the FDA approval of an oral GLP-1 medication. After years of injections dominating the space, a once daily pill introduces a new layer of accessibility, convenience, and patient choice.

He walks through how these medications actually work in the body, from slowing gastric emptying to quieting food noise, and why they’ve been so impactful for patients struggling with weight loss. The conversation stays grounded in real-world considerations, including affordability, insurance access, and the role compounding pharmacies have played as demand surged.

There’s also a thoughtful comparison between competing medications, looking at effectiveness, side effects, and what really matters when deciding between options. Questions around long term use, maintenance, and sustainability are part of the reality, not something to gloss over.

It’s not about hype or quick fixes. It’s about understanding what’s changing, what’s promising, and what still requires careful consideration as this space continues to evolve.

Contact Dr. Tim Sayed:
Phone: (858) 247-2933
Email: info@timsayedmd.com
Website: timsayedmd.com
Instagram: @timsayedmd
YouTube: @Timsayedmd
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Transcript

SPEAKER_00 0:04

Welcome back, listeners to The Scalpel's Edge. I'm your host, Dr. Tim Syed, MD, double board certified plastic surgeon in Southern California with a practice that focuses on holistic health and wellness, breast implant illness, medically supervised weight loss, and other aspects of holistic health. As many of you know, our podcast focuses on helping you establish your best self by performing on what I like to call the scalpel's edge, that bleeding edge of life. So all the things that go into your physical, emotional, mental, and spiritual uh well-being, we like to talk about on this podcast. As many of you know, my practice focuses heavily on breast implant illness and medically supervised weight loss, along with other aesthetic, plastic surgery, and wellness uh areas. On our podcast, we've spent a lot of time talking about the latest and greatest developments in the GLP 1 medically supervised weight loss arena. And today we are going to do the same. It's no exception. There's some recent news about oral GLP1 medications FDA approved, and we're gonna talk about how that landscape is changing as well as some of the aspects of the affordability and accessibility of these drugs. So without further ado, uh, we're gonna go over a recent announcement of an uh FDA approval of an oral GLP1 medication. And for those of you who may be new to the podcast or uh who don't remember what GLP1 stands for, it's glucagon-like peptide analogs, GLP. Um, and glucagon is one of the hormones that is produced and secreted by your pancreas organ in response to levels of blood sugar and energy requirements. And you can think of it as the antidote or the antagonist to insulin. Um, you've probably heard about insulin and insulin resistance playing a role in uh type 2 diabetes and um and insulin um uh underproductivity or lack of production being the cause of type 1 diabetes. Um glucagon is kind of the thing that works opposite insulin. So when you don't have enough sugar, don't have enough energy stores for your metabolic needs, then glucagon will do the trick and will get secreted by your pancreas and then will act on your liver and uh fat and other and even muscle and other stores of energy in your body to recruit those molecules uh and convert them into what you can use for energy production. Um so what uh GLP1 drugs do is basically trick the body into thinking that it's uh needing to um consume its own internal stores of energy rather than getting sugar and other you know, glucose and other stores of energy from the outside. So the GLP1s act by sort of mimicking that glucagon effect, and it works both on your uh stomach organ, slowing the stomach's transit time or the emptying time so that food stays in your stomach longer, and I mean the stomach organ itself, not just the abdomen, but the stomach, first part of your GI tract after the esophagus, and slows that down so that you feel fuller, longer, and earlier with smaller amounts of food. And then it works on your brain as well, on the urge centers by helping to reduce your um triggers, your urges for uh consumption, not just food, but it seems to also curb a lot of other urges. And uh those two things working together tend to reduce your need to eat, the frequency with which you're eating. It makes you go longer hours without eating, so it puts you into intermittent fasting, and it um curbs your brain's sort of food noise that makes you think about food and uh you know want to eat out of boredom and that sort of thing. So um these medications have been nothing short of revolutionary. They've really changed the landscape for weight loss, particularly for severely overweight patients and type 2 diabetics and pre-diabetics. And as many of you know, there have been um a number of um steps taken to uh increase the accessibility of these drugs. One of those steps has been the compounding pharmacies, uh and we work with some of these through the Dr. Well program that allows us to offer medically supervised weight loss in our uh plastic surgery practice. But basically, the um these medications uh were on a shortage uh because they were becoming so popular. A lot of people who were trying to get it through their insurance, who met even criteria to get it through insurance, weren't able to find the drugs, the brand name drugs. They were running behind on productivity. So the FDA allowed compounding pharmacies to basically produce clones of those drugs and to uh uh increase availability. Um then uh the two big manufacturers, Eli Lilly and Novo Nordisk, increased their capacity and produced more product, and then the FDA said, okay, it's no longer on the shortage list. Uh it doesn't mean it's illegal to compound these, but there are going to be some more restrictions on um patient-specific prescriptions that you can do. And then now Eli Lilly and Novo Nordisk are really going after the compounding pharmacy market and the and the pharmacies themselves. Um, and the Trump administration is partnering with those two big companies to make affordability and accessibility to the brand name drugs uh more widespread with through discounting and direct-to-consumer rebate couponing programs and so on under the TrumpRx.gov um name. And you can see that on that website. So that landscape is shifting, and uh, at the same time that you know they're trying to make these drugs more affordable and more accessible. There's still a lot of fear that some patients have about having needles. So people are needle phobic. I don't love getting needles. I mean, I get shots when I need to, and I've been on these medications myself for two years, but um, you know, I don't love getting my blood drawn any more than the next person. I don't like having needles put in me for vaccines and other things any more than the next person. But um I do what I think is medically appropriate and necessary for me and for my family, and sometimes that's shots. Um, but the landscape is shifting with oral medications now being FDA approved, and we're gonna get into the most recent announcement regarding that. So this is from April 1st. This is not an April Fool's joke. This is real, um, and it's very recent. The FDA approves Lily, uh Eli Lilly's Foundo, F-O-U-N-D Found A Y O Foundeo, which is their trade name of the molecule called orforglipron, which I always thought was kind of a weird-sounding name. We talked about it on a previous podcast, uh, some of the data that was presented, and that was shy of the actual approval. Now we have the approval, and it is the only GLP1 pill for weight loss that can be taken any time of day without food or water restrictions. So that was something that we uh uh spoke about on a previous podcast. So we're gonna talk you through a little bit more of the data in detail. So adults taking this medication found DO lost an average of 20 pounds on the highest dose in the attain one clinical trial. Um, and uh Lilly's um uh basically Lilly Direct, direct to consumer uh program to make things affordable with free home delivery is going to start at$25 per month if you have commercial insurance coverage and you meet insurance criteria, which we'll talk about a little bit later about what does that really mean. And then$149 a month for self-pay patients, which is certainly cheaper than typically you've been able to get the injections or uh the compounded injections, even uh with the discounting that compounding can provide. Uh so this may change the landscape again of what people do, but only obviously if the oral medications are effective on weight loss. And clearly this announcement is um to give us that information and tell us how effective they are. So uh basically uh in the press release from Lily, it says that when used alongside a reduced calorie diet and increased physical activity, and people are like, well, duh, if I reduce my calories and I increase my physical activity, I'm gonna lose weight. Well, yes and no. I mean, yes, for sure, reducing your calories and what kinds of calories you get and when you get them is extremely important, probably even more important really than the physical activity. Um, but clearly um they're not going to recommend that you just binge eat or eat a lot of junk food and fast food uh and claim that these drugs are just complete miracle uh drugs. So there has to be some uh comprehensive effort, and it's in your best interest anyway, to uh increase your exercise and to make sure you're eating lower caloric foods and smart uh foods, antioxidant foods, lower carbs, and so on and so forth that people pretty much I think know a lot about uh at this point. So when re when used alongside a reduced calorie diet and increased physical activity, Foundo helps individuals lose excess body weight and keep the weight off. So that's the other really important part is keeping the weight off. That's something I'm struggling with right now to figure out what the right regimen is for me because I've lost a lot of weight, like 45 pounds over the course of a year and change, and then I maybe regained about six to seven of those pounds, still feel pretty healthy and definitely look slimmer, much slimmer than I did. Patients who haven't seen me in two years. Sometimes I have patients come back to see me, they want more surgery, or want me to check something about their prior results or what have you. And I just saw one today and she said, Oh, you look different. And I said, Well, what do I look different? How do I look different? She said, You look like you are healthier or you lost weight. I'm like, Yeah, both. Uh and it's thanks to the GLP1. So um uh, but you know, it's hard to keep the weight off, and you have to ask yourself, am I gonna stay on these drugs for life? A lot of people obviously, both financially and in terms of staying on a medication chronically, don't love that idea, although plenty of people are on chronic medications for other things, like taking a baby aspirin every day after a certain point in life, if you have heart attack risk or stroke risk in your family, or taking um blood pressure or cholesterol medications that often are things that people don't get off of, or ADHD or antidepressant medication and so on. I mean, you know, while there may be some stigmas about um requiring to be on medications uh for life after you get prescribed something, um, it doesn't need to be stigmatized. And sometimes there are things you just do as part of maintenance, and sometimes that's medication, and sometimes it's more natural occurring substances and other lifestyle choices. So anyway, as we talk about this, you know, the key is that it helps people lose weight and keep the weight off. So let's talk about what the data really shows. You're listening to The Scalpel's Edge. I am your host, Tim SyedMD, double board certified plastic surgeon in Southern California with a practice that focuses on holistic health and wellness, including breast implant illness and medically supervised weight loss and general holistic health. On our podcast, we discuss all the things that go into optimizing your personal performance so you can live on that bleeding edge or what I like to call the scalpel's edge of life. So today we're talking about a recent FDA approval and a press release announcement by Eli Lilly, one of the two big manufacturers of GLP1 medical weight loss drugs, with their oral medication Foundado, the trade name or the brand name for or for glipron, which is their uh the generic name. So in this press release uh from a couple days ago, uh there's a quote from uh uh Dr. Deborah Horn, who is the director of the Center for Obesity Medicine at the McGovern Medical School at UT Health in Houston, my hometown. And uh she says that uh people living with obesity need treatment options that meet them where they are. And for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment. And this is contrasting it basically with weekly injections, either self-administering injections, as our patients get trained to do if they're comfortable with it, or going to a doctor or a nurse uh to be injected uh uh on a weekly basis, which is obviously a lifestyle consideration, both in terms of the needle and in terms of the scheduling of all of that. So the attained clinical trial program uh was um used to enroll patients and to um test the theory of whether um the this oral medication can help patients achieve weight loss and whether they can keep the weight off. So um individuals who took the highest dose of foundeo and who stayed on treatment lost an average of 27.3 pounds, which is about uh 12.4%. Um and then that was compared to 2.2 pounds or 0.9% with placebo. So patients taking Foundeo, regardless of whether they finished the trial, they lost an average of 25 pounds, um, compared to 5.3 pounds with the placebo. So placebo is obviously not an active drug. You're not comparing this, say, to getting a shot of Wagovee or Ozampic or Munjaro Zeppound. You're comparing this to taking a dummy water pill. But um, so it clearly shows it's an active uh and effective drug. Um it also led to reductions in many of the markers of cardiovascular risk, which include the circumference of your waist, which is the measure of your total sort of body fat, your visceral and your um subcutaneous fat that's under the skin around this midsection, spare tire, if you will. Um, non-HDL cholesterol, we think of cholesterol as having the good one, which is HDL, and the bad one, which is non-HDL, and triglycerides, which is another component of fat and heart attack risk, and then systolic blood pressure. And this was across all doses, so not just at the highest dose. So it turns out, um, according to the CEO of Eli Lilly, who obviously has a vested interest in more people getting GLP ones, he says that, quote, today, fewer than one in ten people who could benefit from a GLP one are taking one, held back by access, stigma, perceived complexity, or the belief that their condition isn't serious enough for treatment, we believe Foundado can help level the playing field for those living with obesity or who are overweight and living with weight-related complications. So the uh the article goes on to say that Lilly is committed to making it accessible and affordable. So if you have, if you're eligible for the FDA on label indication and you have commercial insurance, you might pay as little as$20.5 a month with their Foundo savings card. And if you opt for self-pay, you can get it starting at$149 a month for the lowest dose. Obviously, it will go up as doses increase. And then if you are a Medicare patient with eligible Part D, you may be able to get it for uh$50 a month beginning as soon as July 1st of 2026. So uh they do go on to disclaim that using this uh in combination with other GLP1s is not recommended. So it's uh it's also not known whether it's safe and effective for kids. Uh it may cause tumors in the thyroid, including thyroid cancer. Um, and that's a little bit different from what you typically read about or hear about with the injectables, where you think more about GI side effects and potential pancreatitis or pancreatic inflammation. So you have to watch out for potential symptoms of thyroid issues. And then, of course, the most common side effects are similar to the injectable medications nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, swollen belly, feeling tired, belching, heartburns, or GI things for the most part, and then hair loss, which is another thing that we've heard from some patients. Um they're not all, these are not all of the possible side effects, another disclaimer. Um, and then they refer uh to their full prescribing information medication guide if you want to learn more. Uh the president, CEO of the Obesity Action Coalition, uh uh Joe Nadglauski, um says there's no single path that works for everyone living with overweight or obesity. New treatment options expand choice and help more people find care that fits their lives, their goals, and where they are in their journey, whether they're just starting to explore treatment or looking for a different long-term approach. Now, Lilly has submitted this drug for weight management and uh type 2 diabetes in more than 40 countries, and they plan to launch in each country shortly after approval. So a big push here uh to um to get this out there globally. The attained study through which they got this data is a phase three, which is a you know fully randomized uh controlled uh trial, and it is a global trial. It's a 72-week randomized double-blind placebo-controlled trial. It compares the efficacy and safety of this drug at various doses to placebo in adults with obesity or overweight with at least one of the following conditions. So you have to be either obese by criteria on BMI, body mass index threshold, or you have to be overweight. Um, usually overweight is somewhere around a BMI of 27 or so. Um, and you have to have at least one of these conditions: high blood pressure, high cholesterol or or triglycerides, which is called dyslipidemia, obstructive sleep apnea or cardiovascular disease, and you have to also not have diabetes for this trial. So they this was not a test of its efficacy in type 2 diabetics, but in uh overweight and obese patients who, uh many of whom, of course, are pre-diabetic, and uh, but that actually having met the criteria of diabetes would exclude you from this because they wanted to specifically get the FDA to approve it for weight loss in non-diabetics. So that's a key uh important thing to understand. It randomized 3,127 participants, and the countries of study were U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, uh interesting, Spain and Taiwan. And they checked multiple different doses against placebo and encouraged healthy diet and physical activity. And um that was the Attain 1 study, and the Attain II study is similar, 72-week uh trial, uh, some of the same countries, some different ones, and this was 1,600 participants, and uh the objective of that was to show that it was superior to placebo in mean body weight change from baseline. So not just in uh the uh body weight reduction from baseline, but in uh mean body weight change from baseline. So these are two uh complementary studies, and um the results are good. So um, of course, right now in the market for um GLP1s, you have uh two competitors. You have Eli Lilly, who we just discussed at uh is releasing or Forg Lapron um Foundado uh to the market with FDA approval now. Um Novo Nordisk is the other company. And so not to be outdone, Novo Nordisk. Uh, one day after the press release from Eli, uh Lilly comes out with this statement, which is that their oral Wagovi, which has been on the market now FDA approved for a few months, demonstrated significantly greater mean weight loss than Lilly's rival pill Foundo, which was approved this week. And um let's go through some of that data so we can just see how these compare. So Novo's findings evaluated studies that were previously published of the medicines and did not include any new data points. So it's really just sort of here's what our study showed, here's what Eli Lilly's study shows for their new drug, and we think our data is better than this, and this is why. So they said a separate analysis suggested 84% of patients favored a drug profile similar to that of semaglutide, which is the active ingredient in Wagovi and Ozempic. So oral Wagovy is oral semaglutide. Um this or glipron is a different GLP1 that is not in an uh injectable form currently FDA approved in the U.S. Um, so they said that um patients favored a profile similar to that of semaglutide. I'm not sure what that really means. I mean, patients favor what works and what doesn't have too many side effects and what they can afford, I mean, in my experience. So um we'll see if they get in any more of that detail. But basically, um it says that uh there's sort of this issue of efficacy versus ease. Um so Eli Lilly is touting that Foundo is more accessible, it can be fitted into your daily routines. Um their CEO, Dave Ricks, told CNBC on an interview that you can see online on CNBC.com's uh uh website. Um, and the fact that it can be taken about food restrictions, whereas Wagovy pill needs to be taken first thing in the morning on an empty stomach with only a small amount of water, and you have to wait about 30 minutes before eating. So, you know, I think that with to unpack this, I think that, you know, with any, you know, com competition, it's like McDonald's comes out with something, Burger King has to come out with something similar and tell you why they think it's better. And you have to have something that differentiates it. They can't be just clones because then it makes it very hard to know how why to choose something other than just existing loyalties or cost. And so um, you know, I think this idea of the convenience, you can just take it any time of the day, I guess that's nice. But I also think a lot of people who take medications are not constrained too much by the fact that they have to take certain medications with food or not. Like people take antibiotics where they have to, some of the time you have to be on a full stomach, sometimes you are supposed to take it without having eaten. Um, and I think as long as people understand what the instructions are for the particular medication, they're usually pretty flexible as long as it's not too restrictive, too onerous, too, you know, challenging to kind of basically understand what the do's and don'ts. Um so earlier studies showed that oral Wagovi results in an average of 16.6% weight loss, whereas Fi Foundo showed 12.4% on average among the patients who stayed on the treatment. Um so there's sort of this question of all right, um, you know, is Wagovie going to be more effective and therefore what people are really going to reach for, or is this convenience of not having to take it on an empty stomach and all that uh going to prompt more people to uh take the uh Eli Lilly drug? So um it's you know, um that's kind of interesting. And then there's a comment from From an investor analyst, Barclays analyst, James Gordon, in the CNBC story, who says following a strong launch of oral Wagovi, the number of patients being prescribed the starter dose seems to be flattening. And prescriptions skyrocketed after Wagovi pill was launched with 600,000 patients having uh begun taking the pill since it was launched in early January. So analysts, according to this article, have described it as, quote, one of the best launches of a new medicine ever with initial uptake quicker than injectable versions. But again, having uh had a this strong launch, the number of patients being prescribed the starter dose seems to be flattening. And, you know, slowing new starts could be the result of patient warehousing as physicians are now awaiting uh Lily's Foundaleo launch to sort of say, okay, what are we really going to prescribe? Let's see what that uh having two things in our toolkit to then have choices. And those choices may be impacted by things like co-pays, deductibles, accessibility with insurance, um you know, capitation. If you're uh in-network provider on an HMO and you're trying to constrain costs, there could be a lot of different considerations there that are maybe beyond the scope of what we're going to talk about today, but uh play a role in adoption. Um so uh the expectations from an investor standpoint uh for sales of Foundado have come down over the last month from uh what was estimated to be$4 billion in sales to$1.6 billion, according to a capital markets analyst. And um and that's partly because I think the pricing has gone down. And they even talk about this, what they call pricing erosion. Um, but there may be upside when it gets expanded to Medicare uh eligibility. So, you know, we'll have to sort of see what the how the pricing all settles out. The pricing war is really, I think, this race to the bottom that was driven by the compounding pharmacies undercutting, so much so that these two companies are suing a lot of the compounding pharmacies and their regulatory uh and lobbying uh groups and professional associations to try to really curtail the compounding market. Um so as those of us who prescribe these uh compounded medications are following this, we kind of aren't sure what that will mean for that element of our practices. But at the end of the day, most of us, if we're good physicians, really care about just what makes things more available to patients so that patients have choice and patients will have um better outcomes. So Novo said that their findings uh suggest that the Wagovi pill can offer differentiation, which has been an important consideration as this space of antiobesity is getting more and more competitive, and there are new products that are going to be launched in the next few years, hopefully with even more efficacy and even fewer side effects. Um, in terms of discontinuation rate, like how many patients, like the attrition, how many patients go off of the meds. Um, the cross-trial comparison published Thursday showed that Lilly's new medicine was associated with about four time 14 times higher odds of stopping treatment due to side effects than the Wagobi pill. I don't know why this is buried, this is called burying the lead, like you know, something that should really be kind of talked about earlier, but it's you know showing up very late in this article. Um, that's really significant. Um, fourteen times higher likelihood of attrition uh to me is a really considerable difference between these two drugs. Um and so if you talk about being more effective and more likely for people to stay on it with better side effects, then does it really matter if you have to take it on an empty stomach? I mean, you know, what are we weighing in comparison here? So it's just my thoughts on this. I think that um the empty stomach thing is is really kind of almost a red herring. Uh, but we'll see how the market uh treats that and what they think as this um uh competition heats up further. You're listening to The Scalpel's Edge. I'm your host, Tim Site, MD, double board certified plastic surgeon in Southern California. We've been talking about uh Eli Lilly's recent announcement of FDA approval of their oral GLP1 drug, which uh stands to give uh oral Wilgovee some competition in the market coming up. And we'll have to keep watching and seeing how this landscape evolves as these drugs you know go post-launch. We kind of see after the first year or so of how they perform and you know how many patients stay on them. Are they maintaining people's weight loss? Um, do you have to stay on them for a lifetime? What does that look like for people both financially and um in terms of convenience and side effects? So we're gonna stay tuned to this. Um, and obviously you know that as I learn more, I will share it with you. My listeners here. And uh with that, I think we're gonna wrap up the discussion of this announcement and um just thank everybody for listening. I've been your host, Tim SedMD. If you are um enjoying what you're hearing on the Scalpel's Edge, please do listen to, rate, and review all episodes wherever you get your podcast content and uh give us suggestions, send us um messages on topics you'd like us to cover. Uh we will have some guests coming up on some future episodes uh to talk about psychology of various things like breast implant illness, um, patient journeys, uh the psychological preparation, and so on and so forth, uh, lymphatic massage specialists and other people that um are involved in the care of our patients that uh can give their perspectives on um uh the role that those play in in uh the health journey and wellness journey of a patient. So until we meet again, this is Tim Sight MD signing off on the Scalpel's Edge, and as always encouraging you to keep on keeping on. Thanks.