Just about a year ago, the U.S. Food and Drug Administration approved Novo Nordisk’s blockbuster obesity drug, Wegovy, for use in teens ages 12 and up with a BMI at or above the 95th percentile for their age and sex. The decision came a little more than six months after the drug was approved for adults.
You might ask, why the hurry? And, do teenagers really need weight-loss drugs?
According to the CDC, 22% of adolescents aged 12 to 19 years have obesity. Since the 1980s, obesity rates have tripled in children and quadrupled in adolescents. In January 2023, given the relative safety and efficacy of the weekly injectable—in clinical trials, young people who took Wegovy had a 16.1% mean decrease in BMI at 68 weeks—the American Academy of Pediatrics gave its stamp of approval. It was the first time in 15 years that the group, the largest professional association of pediatricians in the U.S., had updated its guidance for treating childhood obesity, which it calls a “common chronic disease that has been stigmatized for years and is associated with serious short and long-term health concerns when left untreated.” Now, physicians are advised to offer adolescents ages 12 years and older with obesity “weight loss pharmacotherapy,” in addition to “health behavior and lifestyle treatment.”
According to many providers who treat pediatric metabolic disorders, this is a positive step in de-stigmatizing a disease that affects 14.4 million U.S. children in the U.S. But some pediatricians have been reluctant to prescribe weight-loss medications, citing a lack of data on long-term effects, difficulties with insurance coverage, and a continuing shortage of the drugs themselves.
A year-old “metabolic health” clinic called Knownwell wants to change that, and to make sure that the young people who need the powerful anti-obesity drugs known as GLP-1 agonists can get them. Based in Needham, Massachusetts, Knownwell launched in January 2023 and currently serves nearly 2,000 active patients with its virtual and in-person primary care and metabolic services (i.e., weight-control support). Starting today, it’s expanding its metabolic services to patients 13 and up. These patients will be able to visit a Knownwell doctor either in person or online, and obtain a prescription for Wegovy if they meet the criteria. (There is no membership fee for Knownwell—everything is billed through insurance.)
Knownwell cofounder and CEO Brooke Boyarsky Pratt, who battled childhood obesity herself, hopes to change the conversation around obesity. “We know from the data that treating the disease earlier improves the disease state over time, and protects it from getting more severe, more quickly,” she says. “We also know from the data that lifestyle programs alone are only going to help about 10% of people to lose 20% of their body weight. A lot of kids and adolescents are in the gym, they’re working on their diet, they’re doing all this stuff, and they’re still struggling with often-severe obesity.”
The futility, for people of all ages, of lifestyle-only interventions, is a big reason that WeightWatchers last week launched online prescription program for adults featuring weight-loss drugs including Wegovy and Eli Lilly’s competing product, Zepbound. (Zepbound is not yet approved for patients under age 18.)
Knownwell’s cofounder and chief medical officer Angela Fitch, associate director of the Massachusetts General Hospital Weight Center and faculty at the Harvard Medical School, says that the benefits of the drugs for those who need them outweigh the risks. Semaglutide, the active ingredient in Wegovy as well as Novo Nordisk’s Ozempic, has been on the market and widely used since early 2017. Novo Nordisk’s earlier weight-loss drug liraglutide (Saxenda) has been approved for adults since 2014, and for patients 12 and up since December 2020. “From the data we have so far, at least, we don’t have long-term concerns about these medications causing something untoward to happen from a side-effect profile,” says Fitch.
In clinical trials, adverse reactions with Wegovy in patients aged 12 years and older were similar to those reported in adults—primarily nausea, diarrhea, vomiting, constipation, and abdominal pain—although adolescents had greater incidences of hypotension, rash and hives, and gallbladder issues compared to adults. “It is one of those things we call out and make sure patients are aware of, so they can be mindful of that and get treatment if they are having side effects,” says Fitch. Knownwell also provides prescriptions in the context of a holistic treatment approach that includes a movement program, dieticians, and health coaching.
One thing patients need to understand up front is that, once you start on the medications, you need to stay on them in order to maintain weight loss. “It’s a chronic disease, and you do have to continue to take them in order to see the benefit,” says Fitch. “In the future, I think there will be the ability to potentially take a break from them and be off for a period of time. The issue is you can’t let people gain weight back. If you gain weight back, you’re actually sicker than you were before.”
The current list price of Wegovy is about $1,300 for a one-month supply, but if your insurance covers the drug, you might pay as little as $25 a month. (It bears mentioning that Fitch received more than $17,000 in consulting and speaking fees and meals and transportation from Novo Nordisk in 2022, and at least $60,000 since 2016.) “I have been a consultant for every single company that makes anything to do with obesity,” Fitch says. “We consult because we want to share information and make the world a better place for everybody, and there’s an hourly rate that’s reasonable.”
Amy Beck, a researcher at University of California San Francisco and a pediatrician who sees patients at the Children’s Health Center at Zuckerberg San Francisco General, says that while Wegovy has been very hard to get due to shortages, in kids 12 and up, the drug makes sense “for adolescents who have obesity with significant complications,” including pre-diabetes, liver disease, and significantly elevate blood pressure, and who are at risk for developing Type 2 diabetes or having a heart attack at a young age. “For metabolically healthy kids with obesity, I feel kind of torn,” she says. “I wouldn’t want to hold [medication] back from someone who really wanted it. But given the lack of long-term safety data and some side effects we know, I would be more cautious.”
In the not-so-distant future, Wegovy and other weight-loss drugs could be available for kids as young as six. Novo Nordisk confirms that it is running ongoing trials of both liragulide and semaglutide (Wegovy) for obesity in a pediatric population between 6 and 12 years old. Eli Lilly is conducting a trial of its drug tirzepatide (Zepbound) in children as young as 10 years with Type 2 diabetes, and is planning a clinical trial in patients six years and older who have obesity, according to a report in Bloomberg.
Prescribing for kids that young would be a much harder decision, says Beck. “Even in adolescents, the younger the patient is, the more I’d be cautious.” She notes that in the Wegovy trials of adolescents, most of the subjects were nearly or completely done with pubescent development. “A caveat in my mind is: What happens if a kid has a lot of growth left, and you suddenly cause their food intake to go down a lot? At the end of the day, people lose weight on these drugs because they eat very little.”
Fitch at Knownwell says that if the drugs were cleared for age six and up, the providers in her clinic would prescribe them. “If a kid at six is appropriate for the treatment, there is something typically genetically involved,” she says. “I remember one time taking care of a six-year-old that was 185 pounds. This is not okay. He’s not going to live a healthful life. We’re not talking about just [giving them to] a random six-year-old that needs to lose a little bit of weight.”
Investors like the model. Launched with $4.5 million in seed funding, Knownwell is announcing a $20 million Series A round, led by A16Z, along with its adolescent launch today.
Just about a year ago, the U.S. Food and Drug Administration approved Novo Nordisk’s blockbuster obesity drug, Wegovy, for use in teens ages 12 and up with a BMI at or above the 95th percentile for their age and sex. The decision came a little more than six months after the drug was approved for adults.
You might ask, why the hurry? And, do teenagers really need weight-loss drugs?
According to the CDC, 22% of adolescents aged 12 to 19 years have obesity. Since the 1980s, obesity rates have tripled in children and quadrupled in adolescents. In January 2023, given the relative safety and efficacy of the weekly injectable—in clinical trials, young people who took Wegovy had a 16.1% mean decrease in BMI at 68 weeks—the American Academy of Pediatrics gave its stamp of approval. It was the first time in 15 years that the group, the largest professional association of pediatricians in the U.S., had updated its guidance for treating childhood obesity, which it calls a “common chronic disease that has been stigmatized for years and is associated with serious short and long-term health concerns when left untreated.” Now, physicians are advised to offer adolescents ages 12 years and older with obesity “weight loss pharmacotherapy,” in addition to “health behavior and lifestyle treatment.”
According to many providers who treat pediatric metabolic disorders, this is a positive step in de-stigmatizing a disease that affects 14.4 million U.S. children in the U.S. But some pediatricians have been reluctant to prescribe weight-loss medications, citing a lack of data on long-term effects, difficulties with insurance coverage, and a continuing shortage of the drugs themselves.
A year-old “metabolic health” clinic called Knownwell wants to change that, and to make sure that the young people who need the powerful anti-obesity drugs known as GLP-1 agonists can get them. Based in Needham, Massachusetts, Knownwell launched in January 2023 and currently serves nearly 2,000 active patients with its virtual and in-person primary care and metabolic services (i.e., weight-control support). Starting today, it’s expanding its metabolic services to patients 13 and up. These patients will be able to visit a Knownwell doctor either in person or online, and obtain a prescription for Wegovy if they meet the criteria. (There is no membership fee for Knownwell—everything is billed through insurance.)
Knownwell cofounder and CEO Brooke Boyarsky Pratt, who battled childhood obesity herself, hopes to change the conversation around obesity. “We know from the data that treating the disease earlier improves the disease state over time, and protects it from getting more severe, more quickly,” she says. “We also know from the data that lifestyle programs alone are only going to help about 10% of people to lose 20% of their body weight. A lot of kids and adolescents are in the gym, they’re working on their diet, they’re doing all this stuff, and they’re still struggling with often-severe obesity.”
The futility, for people of all ages, of lifestyle-only interventions, is a big reason that WeightWatchers last week launched online prescription program for adults featuring weight-loss drugs including Wegovy and Eli Lilly’s competing product, Zepbound. (Zepbound is not yet approved for patients under age 18.)
Knownwell’s cofounder and chief medical officer Angela Fitch, associate director of the Massachusetts General Hospital Weight Center and faculty at the Harvard Medical School, says that the benefits of the drugs for those who need them outweigh the risks. Semaglutide, the active ingredient in Wegovy as well as Novo Nordisk’s Ozempic, has been on the market and widely used since early 2017. Novo Nordisk’s earlier weight-loss drug liraglutide (Saxenda) has been approved for adults since 2014, and for patients 12 and up since December 2020. “From the data we have so far, at least, we don’t have long-term concerns about these medications causing something untoward to happen from a side-effect profile,” says Fitch.
In clinical trials, adverse reactions with Wegovy in patients aged 12 years and older were similar to those reported in adults—primarily nausea, diarrhea, vomiting, constipation, and abdominal pain—although adolescents had greater incidences of hypotension, rash and hives, and gallbladder issues compared to adults. “It is one of those things we call out and make sure patients are aware of, so they can be mindful of that and get treatment if they are having side effects,” says Fitch. Knownwell also provides prescriptions in the context of a holistic treatment approach that includes a movement program, dieticians, and health coaching.
One thing patients need to understand up front is that, once you start on the medications, you need to stay on them in order to maintain weight loss. “It’s a chronic disease, and you do have to continue to take them in order to see the benefit,” says Fitch. “In the future, I think there will be the ability to potentially take a break from them and be off for a period of time. The issue is you can’t let people gain weight back. If you gain weight back, you’re actually sicker than you were before.”
The current list price of Wegovy is about $1,300 for a one-month supply, but if your insurance covers the drug, you might pay as little as $25 a month. (It bears mentioning that Fitch received more than $17,000 in consulting and speaking fees and meals and transportation from Novo Nordisk in 2022, and at least $60,000 since 2016.) “I have been a consultant for every single company that makes anything to do with obesity,” Fitch says. “We consult because we want to share information and make the world a better place for everybody, and there’s an hourly rate that’s reasonable.”
Amy Beck, a researcher at University of California San Francisco and a pediatrician who sees patients at the Children’s Health Center at Zuckerberg San Francisco General, says that while Wegovy has been very hard to get due to shortages, in kids 12 and up, the drug makes sense “for adolescents who have obesity with significant complications,” including pre-diabetes, liver disease, and significantly elevate blood pressure, and who are at risk for developing Type 2 diabetes or having a heart attack at a young age. “For metabolically healthy kids with obesity, I feel kind of torn,” she says. “I wouldn’t want to hold [medication] back from someone who really wanted it. But given the lack of long-term safety data and some side effects we know, I would be more cautious.”
In the not-so-distant future, Wegovy and other weight-loss drugs could be available for kids as young as six. Novo Nordisk confirms that it is running ongoing trials of both liragulide and semaglutide (Wegovy) for obesity in a pediatric population between 6 and 12 years old. Eli Lilly is conducting a trial of its drug tirzepatide (Zepbound) in children as young as 10 years with Type 2 diabetes, and is planning a clinical trial in patients six years and older who have obesity, according to a report in Bloomberg.
Prescribing for kids that young would be a much harder decision, says Beck. “Even in adolescents, the younger the patient is, the more I’d be cautious.” She notes that in the Wegovy trials of adolescents, most of the subjects were nearly or completely done with pubescent development. “A caveat in my mind is: What happens if a kid has a lot of growth left, and you suddenly cause their food intake to go down a lot? At the end of the day, people lose weight on these drugs because they eat very little.”
Fitch at Knownwell says that if the drugs were cleared for age six and up, the providers in her clinic would prescribe them. “If a kid at six is appropriate for the treatment, there is something typically genetically involved,” she says. “I remember one time taking care of a six-year-old that was 185 pounds. This is not okay. He’s not going to live a healthful life. We’re not talking about just [giving them to] a random six-year-old that needs to lose a little bit of weight.”
Investors like the model. Launched with $4.5 million in seed funding, Knownwell is announcing a $20 million Series A round, led by A16Z, along with its adolescent launch today.