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Hello and welcome to Medall's Education CGA, the Global Obesity Pulse Translating Evidence into Practice. This is the Evidence Pulse, Translating Obesity Science. Hello, my name is Doctor Fatima Cody Stanford. I'm an obesity medicine physician scientist at Mass General Brigham and at Harvard Medical School. I want you to know to claim your CME credit. I'll be saying that throughout today's presentation. This activity is intended for primary care providers who care for patients with obesity. We do have several learning objectives, which include the following. We're gonna evaluate new clinical trial data and advise evolving clinical guidelines to utilize individualized treatment plans for patients with obesity. We're proactively initiate and intensify anti-obesity therapies using a structured chronic disease-oriented approach rather than solely treating complications. We'll assess the efficacy of induction therapies to formulate advancing treatment plans that incorporate Appropriate maintenance options and prevent relapse. We'll implement AE management strategies and evidence-based dose titration to optimize treatment tolerability. And finally, we'll apply shared decision making and bias-aware communication to partner with patients to set individualized function-based goals for long-term care. So we have a lot in store for us today. These are the disclosures. I will not read them, but you can see them on this slide, so I will pause for a moment. So now, let's finally get to the updates from Eco and advancing individualized obesity treatment strategies. Let's start with 8004.03, and this is CAREMA and the achievement of BMI and waist to height ratio and treatment targets for redefine one. And in particularly in this Calgary summer trial, they looked to examine the percent of participants and redefine one who achieved a BMI of less than 27 and a waist to height ratio of less than 0.5 in the treatment targets, and they sought to assess the percentage of participants who achieved normalization of cardio metabolic parameters and anthropometric changes in participants who achieved or did not achieve their treatment targets. The population in this particular study was those that had a BMI greater than 30 or greater than 27 with one obesity-related complication. And they were randomized for 68 weeks as an adjunct to life's footstyle intervention to either Carisema at a 2.4 to 2.4 mg dose, simaglitide at 2.4, or caglinotide at 2.4, or placebo. And, and, and the results, um, the participants that were achieving their treatment targets, I think it's important for us to look at that here. I want us to look at these three groups. Those that had a BMI of less than 27, awaits to height ratio of less than 0.53 or these combined. And what we can see here is that the Cagry-sema group actually did the best. It's very clear here with 41.4 versus those with the weight to height ratio, um, and we're comparing Caggrisema to simmaglatide, cagrelatide, or placebo. And we can see across the different groups that Caggrisema outperformed all of the other, um, agents. It's also important to know that when we're looking at the results, that weight loss and reductions in waist circumference and participants achieving anthropometric treatment targets. And normalization of cardio metabolic parameters in participants to treatment, treatment targets were also superior in the Calgary-Ema group. We can notice that here, looking at our percent weight loss, if we look at the Calgary-Ema group, those that are achieving treatment targets was highest here in the Calgary-Ema group compared to SEMA alone, caglenatide or placebo. And then let's look at those that were not achieving those treatment targets. We can see that those are much lower here. What about reductions in waist circumference? Here again, Calgaryema winning, um, compared to other groups, and then, of course, patients not achieving treatment targets in the waist circumference group. Let's jump over here to the normalizations of cardio metabolic parameters. We can notice here, 96.3% of those achieved normalization for normal glycemia. 97.7% for triglycerides. Um, now, you'll notice that that's very close here if we look at simmaglatide. Um, let's look at HDL cholesterol. Now, this is one where we see uh some difference. Um, notice that here some simaglatide actually does better. Um, very close here if we're looking at highly sensitive C-reactive protein, and then we're looking at systolic and diastolic BP here. Well, let's come to this callout box here at the bottom of the slide. A greater percentage of participants treated with Cadriema achieved clinically relevant treatment targets, um, and then those achieving a BMI and waist to hip ratio treatment targets were highly likely to achieve normalization of Cardiome metabolic parameters. These data do highlight the link um between new anthropometric targets and the clinical management of obesity and the near normalization of cardio metabolic parameters. So really getting away from just looking at BMI, I think this is something that I really spend a lot of time talking about with patients, um, and really recognizing that BMI by itself doesn't give us the full picture. So, let's move forward. Let's look at another trial. So, we've moved away from that. We're moving into the control of eating with simmaglatide 7.2, right? This is that higher dose simaglatide in adults with obesity in the SEP-Up trial. And let's look at what the aim for this trial was. This is the pre-specified analysis to assess changes in perceived control of eating and disordered eating behavior with simmaglatide 7.2 versus placebo, and then also simmaglatide 2.4 in the step-upp trial. And this particular patient population was adults with a BMI of 30, without type 2 diabetes, with greater than 1 unsuccessful dietary effort to lose weight. There were two co-primary endpoints, that was the percent change in body weight at 7.2 mg versus placebo and the percent with greater than 5% weight reduction, which is 7.2 again versus placebo. There were a few exploratory endpoints. That was the change in the control of eating questionnaire score, which assesses the intensity. and type of food cravings and subjective sensations of appetite and mood, and also um the change in the three-factor eating questionnaire, which was revised 18 item question in version 2. So here, we're gonna look specifically on this slide, the change in body weight. And you can see placebo here. Um, versus simmaglatide at 2.4 and simaglatide at 7.2. And we can see that change in body weight from baseline at 17.5 versus 20.7%. And I think we can see those differences noted with that higher dose, 7.2 mg dosing. Now, let's look further into some things that particularly as we get to that control of eating questionnaire versus that three-factor eating questionnaire that was revised as we look at particular issues with patients that we might see. So let's look at that change of control and eating questionnaire, craving control, positive mood, craving for savory, and craving for sweet. Now, we have to pay attention to these P values, right? Noting that a P value less than 0.05 is the only one that's significant and recognizing that the only one that is truly significant here is this craving. In control. But we can see that the craving control was most um improved here with the simmaglatite 7.2. These are technically not significant positive mood, craving for savory and craving for sweet. Remember that P value less than 0.05 needed to be significant as we look across those. Let's jump over here to that three-factor eating questionnaire and we are going to see some more um significant results, not here in cognitive restraint, but here in emotional eating, um, and uncontrolled eating. We do see some differences and we can also note that that higher dose um of 7.2 is more significant. So in adults with obesity, once weekly subcutaneous somaglatite 7.2 provided significant long-term improvements in the aspects of control of eating and food craving versus placebo. Somaglatite 7.2 and 2.4 did have similar effects on control of eating and food cravings. The greatest effects were observed on craving control as previously specified, emotional eating and uncontrolled eating. Remember, paying attention to that P value of less than 0.05. All right. Let's keep it going. So many great things coming out. Let's look at the Oasis 4. This is the efficacy of oral simaglatide, 25 mg in obesity treatment targets, and low-risk outcome for cardio metabolic risk factors. And then particularly, this study sought to examine the percentage Of participants in Oasis 4 who met anthropometric targets and low-risk outcomes for various cardometabolic factors. Um, and this looked at people with a BMI of greater than 30 or a BMI of 27 plus one obesity-related complications, but without diabetes. Um, the treatment was randomized at 2 to 1 to receive either simmaglatide 25 or placebo plus lifestyle intervention for 64 total weeks. Um, the secondary analysis assessed participants who achieved a BMI of less than 25, a waist to hip ratio of less than 0.5, and low-risk cardio metabolic outcomes for glycemia, meaning a hemoglobin A1C of less than 5.7, a fasting plasma glucose of less than 5.6, HDL of greater.