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Interviewer: In spring of 2022, there were some headlines going around almost every news outlet saying that the FDA had finally approved a new weight loss drug, one that would promised 10% to 25% weight loss with little more than just a weekly injection. The drug is called tirzepatide, or a brand name Mounjaro.

Now, it seems a little too good to be true. So, today, we're going to be looking at what exactly is the drug and what can it actually do for weight management.

Joining us today is Juliana Simonetti. She is the medical co-director of the Comprehensive Weight Management Program at U of U Health. So she knows a thing or two about weight management.

Dr. Simonetti, thank you so much for joining us.

Dr. Simonetti: Yes. Thank you so much for having me here today. I'm very excited to be talking about this new drug.

Interviewer: So why don't we start there? What is tirzepatide and what does it do to the body?

Dr. Simonetti: I'll start by just telling a short story. I was at an endocrine meeting in California two weeks ago when this drug got approved by the FDA for the treatment of diabetes. And we were doing a lecture, and all of a sudden, everyone started clapping and announced that this drug had been approved by the FDA for the treatment of the diabetes. So that's the kind of excitement we're getting with this drug.

It is a new class of medication for the treatment . . . Currently, it's only approved for the treatment of diabetes. However, we have seen really significant amounts of weight loss with the medication, and they are doing clinical trials at this point, and they have the results of the clinical trial for the treatment of obesity with this drug as well.

Tirzepatide is unique in the sense that is a dual incretin medication. It attaches to two different receptors. So we have a class of medication that has been in the market now for about 15 years called GLP-1 receptor agonist. And some of the drugs I think are well known at this point, both for diabetes and for weight loss. All those drugs were initially developed for the treatment of diabetes, and then they found that they led to significant amounts of weight loss.

So some of the drugs currently on the market that are GLP-1 receptor agonists are Victoza, Ozempic, Trulicity, and those drugs really have revolutionized the treatment of diabetes in the sense that they bind to receptors in our body that stimulates our own pancreas to produce insulin. And at the same time, they cross the receptors in our brain and tell us that we're full.

Therefore, when you start eating, you feel fuller sooner. It leads to induced satiety, so therefore people eat less, and it promotes the release of our own insulin so you have better glucose control, better sugar control for the treatment of diabetes. And we have this induced satiety that leads to people eating less, feeling fuller, and therefore losing significant amounts of weight.

Interviewer: So tirzepatide has been approved by the FDA to help manage and treat types of diabetes. But there's a lot of evidence in their, I guess, Phase 3 trials that are showing real potential to help with weight loss. What are they finding?

Dr. Simonetti: That's right. So their clinical trials for diabetes show . . . for those participants that had diabetes, it led to a significant amount of weight loss. And so they also then did clinical trials for this medication for those without diabetes for the treatment of obesity.

And what they found is that they highest dose of the medication, which is 15 milligrams, can reduce body weight on average by 28.4 pounds, which is nearly about 14% of the total body weight. So, for someone that weighs about 200 pounds, they will lose on average of about 28 pounds on this medication, which is really, really significant.

Interviewer: Wow. That sounds like a lot of weight loss for people without diabetes, but what does it do for people who do have type 2 diabetes? What kind of results have they been seeing with them?

Dr. Simonetti: Yeah, the results, it's really interesting because the results for those with type 2 diabetes, on the highest dose, show that those participants lost almost 21% of their total amount of weight, which is really, really impressive. This is more than anything else, any other medication we currently have in the market.

Interviewer: So if I get this correct, there are other . . . I've seen other drugs out there that fill your stomach up, the Plenity or whatever it's called, or they claim to impact your metabolic system, etc., but this drug actually impacts your pancreas in a way to help with glucose levels and help suppress hunger.

Dr. Simonetti: Yes. So the class of medication I was talking about is the GLP-1 receptor agonists that already exist that have been in the market now for about 15 years. The newer ones, one of them being semaglutide, or the other name is Ozempic, has been the latest.

They also got approved for the treatment of obesity and leads to very significant amounts of weight loss and improvement in the sugars in our blood because it stimulates the pancreas to release insulin and tells our brain . . . So it works on the appetite centers of the brain.

The difference between some of these drugs and what you're talking about, Plenity . . . So Plenity is considered a device because it's three capsules that kind of inflate in your stomach and therefore makes you feel fuller, so you have the physical sensation of fullness. However, the GLP-1 receptor agonists work in your brain and in the appetite centers of the brain. It works in the brain to tell you that you're full, so you don't have those cravings and then sensation that you wanted to keep on eating. It really leads to the feeling of feeling fuller.

With tirzepatide, why this is so exciting and different is that this not only works with the GLP-1 receptors, but also works in another receptor called GIP, which is a glucose-dependent insulinotropic peptide. It's a mouthful, but it's really another hormone in our body that is usually . . .

Both of those hormones are released in response to us eating food. So when I eat carbs or sugar, it goes in my stomach and then reaches my stomach and my intestines, my gut. My body says, "Whoa, we got nutrients here." We release the GLP-1 and this other one called GIP hormones that then say, "We got food, we got carbs, we got sugar. Let's tell our pancreas to release insulin," because we just got some food in our body. We got some sugar in our body. And then it crosses the brain and tells the appetite centers in my brain that, "I just got nutrients. We should stop eating." It should make me feel a little fuller.

The issue with our natural hormones in our body is that they get taken down, they get broken down very quickly. They only last a few seconds. And these new drugs bind now to those two different kinds of hormones and lead to this really much heightened sensation of fullness and to a much more significant response lasting much longer than what our own body would produce.

Therefore, that's why they're so effective. And therefore, that's why they are also given once a week, which is really kind of neat for a lot of those medications. So you don't have to take a medication every day. It's a small injection once a week.

Interviewer: Wow. So I guess when I first came into this interview, I'm used to doing stories about how some new drug that came out is not actually going to help you with weight loss when you really look at the research. But with your professional opinion, as a doctor who works with patients suffering from obesity or helping them live healthier with their weight management, why is this drug so exciting like you keep saying?

Dr. Simonetti: It is so exciting because the amount of weight loss we are seeing with the clinical trials from this drug is much more significant than what we had seen previously.

So as a measure for FDA approval for a drug for weight loss is usually about 5%. And with the latest drug, which is semaglutide with the other name of Wegovy, we saw a significant more amount of weight loss, around 14%, 15% with the higher doses. And with tirzepatide, we are seeing weight loss of around 20% with the higher dose of the medication, which 20% is a lot of weight, right? So it's a really significant amount of weight loss that we are seeing with these new classes of medication.

And as we know, weight loss is extremely difficult, right? This idea that if we just diet and exercise, we should just be able to lose weight. And it's not true. Eighty-five percent of those that diet and exercise actually, unfortunately, end up gaining the weight back and this weight loss is not sustainable.

And there are a lot of reasons for that, right? There is genetics. So 60% to 70% of the way we are, we know that it's related to genetics or the way we accumulate fat.

There's also our environment, and then there is this regulation in a lot of the hormones. There are these regulation appetite hormones. There is this regulation with insulin. The more weight that we gain, the more insulin-resistant we become. Therefore, there is this combination of insulin resistance.

So 90% of those that have diabetes also have excess weight. And some of the older medications that we had for diabetes, like the glipizide, glimepiride, and even insulin would lead to more weight gain, which then meant more insulin resistance and then making the condition just worse.

And with these new drugs, we see significant improvement in weight. Therefore, you also see significant improvement in decreasing in insulin resistance and also improvement in the glucose control and the sugar control in the blood because it works in conjunction. You have the stimulation of the pancreas and decrease in appetite.

Reading through the clinical trials again, and I just had done a quick review before we sat down for this interview, really it's quite impressive. One of their trials, they compare this drug for participants that have diabetes that were taking insulin and they gave them the tirzepatide. And those that took the tirzepatide lost weight versus those that were taking insulin actually by itself gained weight. So this is, again, quite significant in the amount of weight loss as well as in the amount of glucose control that we get with this medication.

Interviewer: So for all of the people who are thinking, "Oh, hey, this is the drug that's going to make me lose all my weight, finally," it's not ready for them, right? Is that what I'm understanding correctly?

Dr. Simonetti: That's right. So this medication is not yet approved for weight loss. I believe it will be, hopefully, within the next year or two. They are just finishing the Phase 3 clinical trials for weight loss.

Currently, this medication is approved for those with diabetes, and I think it'll be a wonderful tool for those that have diabetes and excess weight, overweight or obesity. This would be just a wonderful medication because it leads to a significant amount of weight loss and improvement of their diabetes.

This is great, and I think this is going to really improve the care that we can provide. However, we need to remember that obesity is such a complex disease, right? There's a multitude of issues that go with it. So this is addressing maybe some of our physiology, but we still need to do lifestyle modifications with modifications in our diet, increasing physical activity.

Behavioral health is a really important piece. Oftentimes, we eat in response to feeling sad, depressed, because when we eat in particular foods that are sweet or high caloric foods, it releases dopamine and serotonin in our brain. So it actually makes us physically feel better at the moment. And therefore, we go back and eat more because then I need another hit and then I feel better. And it becomes that very vicious cycle that once you start eating certain things . . . know for me, it's a piece of chocolate, right? I'm having a bad day at work, I eat a little piece of chocolate and my life is better at that moment. However, that doesn't help me because then my sugars crash and it makes me want to crave it more.

So really trying to address as many things as possible, and that's why in our program, we have this multidisciplinary team approach. We have the registered dieticians. We have an exercise physiologist. We have two Ph.D. psychologists. We also have other options such as surgery. So we work with the bariatric surgeons.

So again, it's wonderful to have one more tool, a very effective tool in our toolbox, but this is a tool. We are able to use it, and the more tools that we have, I think the better offer we're going to be, but we have to address all these other pieces as well.

Interviewer: So, obesity, it is not as simple to treat as just getting a new injection, even with some of these great new drugs. So I guess we'll just keep a look on the headlines, see if this is approved for obesity treatment in the next couple years, and maybe we'll have you back on and we can talk about how you guys can utilize it in your toolbox to battle obesity.

Thank you so much for joining us, Dr. Simonetti. I really appreciate you taking some time to talk to us about this new drug.

Interviewer: At-home male fertility tests that you get over the counter. You go to the drugstore, you get the fertility test, you take it. Does that give you helpful information? Are they accurate? Are they worthwhile? That's what we're going to find out today from urologist Dr. John Smith. What is your take on those over-the-counter, at-home male fertility tests?

Dr. Smith: We see a lot of people for fertility at the University of Utah, and those at-home tests really are very rudimentary. They don't tell you a lot of information. They pretty much tell you if you have an adequate amount of sperm in the ejaculate or not. And that's really all they can tell you.

So if you had a positive test where it said, "Hey, you've got enough," that doesn't tell you if those sperm are alive, if there's any motion in those sperm, the morphology or the shape of those sperm. It doesn't give you really any other information. The only thing it tells you is if there's enough sperm there to hopefully not have fertility issues.

And the way these tests work is similar to a pregnancy test where it looks for a protein that's only on the sperm. And so that's how they quantify. So you've got to have enough of that protein in order to have the test come back positive that you've got a high enough quantity of sperm to have a normal sperm count.

Interviewer: But if partners have been trying to have kids and they have not been successful, and the man goes and gets this and finds out, "Oh, hey, I've got enough sperm according to this test because they detected enough protein," but you're still not having kids. You really haven't solved anything by taking the test, have you?

Dr. Smith: No. You really haven't. And that's the other part of things that go on. There's also two parties when you're trying to have kids. You've got the male side of fertility and the female side of fertility, and we're going to talk about the male side today.

But if you have been trying unsuccessfully, having unprotected intercourse for over . . . usually the definition is one year. Some people will say six months to a year. But all in all, if you've been trying and you haven't been successful and you get that at-home test and it tells you that there's enough sperm there, that still doesn't tell you that there's not necessarily a problem. Because if there's low motility, meaning you don't have any that can move and get where they need to be, the viability of things, so to speak, and then the morphology, the shape, if they're not the normal shape where they're not going to travel in a uniform way . . . there are a lot of things that go into a sperm test.

And so when we do a semen analysis at the University of Utah in our lab, we get the volume of the semen. It tells us the total sperm count, the sperm concentration, or how much there is per milliliter that's in the sample that we received. It tells us the viability, how many of those are alive and moving. It tells us the motility, how many of them are moving in an adequate amount to be beneficial for you. And then the shape and morphology. So it really gives us a lot more information.

However, the biggest thing I find for most patients is fertility may not be covered under their insurance. So they're looking for a quick test that can give them some information. And that test may or may not be helpful for them because if there is another aspect to the semen parameters that's not good, that's not just the number, then they're never going to see that on the test.

And so I think a lot of people are looking for a cost-effective way to just get some answers, but sometimes the most cost-effective way is just to come in and get a full semen analysis done with a fertility specialist.

Interviewer: Yeah. That way you can discover exactly what the issue is, and then go about perhaps solving that issue if there is indeed an issue.

Dr. Smith: Exactly.

Interviewer: So, from a male perspective, when you get this information back, generally then when you start solving the problem, is it going to be an expensive process or sometimes are there some simple changes that can be made that can make all the difference?

Dr. Smith: It's different for every patient. Some guys come in and they have a hormone-related issue that we can solve with some medication. That can really be an inexpensive fix. Oftentimes a lot of medications are still covered by insurance, which can be helpful.

And then in some men, if there is an issue where there is a low sperm count or no sperm count, some of the procedures to check and see if the testicles have viable sperm in them can be a little bit more expensive.

However, the real expense comes if you had to have IUI or IVF, which are insemination techniques. Most of the male stuff tends to be less expensive than that.

Now, again, when you're looking at things, fertility is not cheap by any stretch of the imagination. A lot of the procedures that are done to check for viable sperm within the testis can run anywhere from $2,000 to $5,000, but then a round of IVF can cost greater than $10,000 upwards, even much more than that.

So, when I talk about cost, it's very interesting because the male side of things generally is a skosh less expensive than the total amount that it takes to get the fertility solved in some cases.

Interviewer: So it is possible that you go and you get the test, you get some solid results, and it might be an inexpensive fix. That is not unheard of.

Dr. Smith: No, not at all, and we do a lot of that. And sometimes if the sperm count looks maybe borderline, we can also try some medication to try to bolster that sperm count for a few months and then do a retest type of thing.

And so a lot of times, we usually don't run right to the higher dollar surgical procedures, things like that, unless they're absolutely needed because we do understand that a lot of times this stuff isn't covered by insurance and we want to try to make it as best we can and most cost-effective for these folks.

It's a tough road. Fertility is tough. I see quite a few folks who we have success with, and it's great to see that, but any of those couples that are having trouble, I would say just get in and see if there's something that can be done to really help you because sometimes it is a simple solution.

Fertility can be one of the toughest portions of a relationship, but also one of the most rewarding. So I would say don't delay. Just get in and see if there is something that can be done to make things easier for you.

Dr. Jones: We read in a newspaper that a famous man is taking an anti-hormone to help his hair grow. Now, what's an anti-hormone anyway, and would it make my hair grow? This is Dr. Kirtly Jones from University of Utah Health, and this is The Scope.

Announcer: Covering all aspects of women's health, this is The Seven Domains of Women's Health with Dr. Kirtly Jones on The Scope.

Dr. Jones: So guys who have male-patterned hair loss, loss of hair on the temples and the forehead can take an anti-hormone, or a hormone blocker to help slow their hair loss. What's this about? Well, male-patterned baldness is partly genetic, and partly related to testosterone. An anti-hormone drug, in this case Finasteride, blocks the conversion of testosterone to the most active form of testosterone in tissue, 5-dihydrotestosterone.

Finasteride blocks that conversion. Incidentally, it was invented to help shrink the prostate in guys with prostrate problems, testosterone makes the prostate gland grow in men, of course only in men, because women don't have one, but it also works for hair.

Well, what about women? Some women's hair loss is related to the same hormone, 5 DHT in the skin of the scalp. Maybe it would help women. Firstly, the FDA specifically says that women shouldn't even go near the lid of a bottle of Finasteride, the lid with a little drug powder in it. This is because 5 DHT is very important in developing boy babies, boy-baby parts in the uterus. And women who are pregnant who are exposed to Finasteride can have boy-baby part birth defects.

What happens if a woman is beyond her child-bearing years and cannot get pregnant, and wants to use Finasteride? Well, it still isn't approved for women, and it doesn't work for hair loss in many women, but there are some studies that it works for some women.

Can a doctor prescribe an FDA-approved drug that isn't approved for women? Legally, she can, but she would have to be really careful about who she prescribes it for and who might take it.

But let's get back to anti-hormones, specifically anti-androgens and anti-estrogens. Anti-hormones, or hormone antagonists, can work either by blocking the production of a hormone or blocking the receptor of the hormone. One of the progestins, called drospirenone in a commonly prescribed birth control, has mild anti-androgen activity because it mildly blocks the testosterone receptor. So it's good for women with acne, but I wouldn't recommend it for men to help their hair grow.

Anti-estrogens are used in a number of conditions for women. Women with breast cancer are often prescribed a drug that blocks the conversion of testosterone to estrogen. Yep, ladies, we make our estrogen out of male hormones. One of these medications is called Letrozole. It turns out that in young women who have ovaries with eggs, but who aren't ovulating, if they take an anti-estrogen, their brain thinks their ovary isn't working and it yells at the ovary to make eggs and estrogen. So this drug is also used for ovulation induction, even though it isn't approved for that use.

Clomiphene is an anti-estrogen because it blocks the estrogen receptor so estrogens can't do their work. It works differently that Letrozole, but they both are anti-estrogens, and they're both used for fertility therapy.

Tamoxifen is commonly used by women with breast cancer, and to decrease the risk of breast cancer in women who are a high risk. It is sort of an anti-estrogen. It blocks the estrogen receptor so estrogen cannot do its work, but it's sort of a weak anti-estrogen. It works differently in different tissues. In the breast and the brain, it acts like an anti-estrogen, so breast cancers don't grow, and women have hot flashes. In the bones in the uterus, it sort of acts like an estrogen, so it keeps women's bones strong. It's complicated.

So why do you need to know about anti-hormones, except to understand famous men's hair issues? These types of drugs are commonly used for women, for infertility, for some types of contraception, for some menopausal therapy, and for some cancer therapy. They all have some side effects. A smart Scope listener should explore how their medications work, and what kind of side effects they have.

Ask your physician. They probably can give you handouts or websites that can explain more, and health researchers actively looking at new anti-hormones, that might help women and men in health and disease. Thanks for joining us in this little lesson on hormones on The Scope.

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