Weight reduction drugs could help treat PCOS

For well over a decade, Grace Hamilton, 27, experienced hair loss, heavy periods, infrequent menstrual cycles, mental health issues and difficulty losing a few pounds without knowing why. It wasn’t until 2021 when she was diagnosed with polycystic ovary syndrome, or PCOS, a hormonal disorder common amongst women of reproductive age.

After she saw limited improvements from contraception, eating regimen and exercise, Hamilton joined a trial in 2024 examining a GLP-1 drug in PCOS patients. By October, she received her first weekly dose of semaglutide, the energetic ingredient in Novo Nordisk‘s obesity injection Wegovy and diabetes shot Ozempic.

She said some results were almost immediate: after months with out a cycle, her period resumed inside two weeks of starting the drug. After 10 months on the treatment, Hamilton lost 50 kilos, saw hair regrowth and reported significant improvements in depression and anxiety

“I’m so glad that I stuck with it since it was just clear as day that it was the missing link for me,” said Hamilton, who works at a nonprofit in Arvada, Colorado, adding that she maintained eating regimen and exercise while on the drug. 

She is just considered one of several women who’ve reported improvements in symptoms of PCOS after using GLP-1s, a growing class of obesity and diabetes treatments which have drawn massive patient demand and investor buzz over the previous few years. Treating PCOS is amongst several latest but unapproved potential uses of the blockbuster drugs beyond promoting weight reduction and regulating blood sugar.

PCOS, which is often underdiagnosed, affects an estimated 5 million to six million women of reproductive age within the U.S., in response to some estimates. 

The condition is usually characterised by higher levels of testosterone and other hormones normally related to men called androgens, which might results in symptoms akin to irregular and painful periods, excess hair growth and pimples. PCOS is probably the most common reason for infertility. 

The condition is strongly linked to metabolic issues, as an estimated 35% to 80% of patients experience insulin resistance. Meaning the pancreas pumps out more insulin to maintain blood sugar in check, and high insulin levels can promote weight gain and disrupt hormone balance. A big share of girls with PCOS have obesity or Type 2 diabetes. 

Yet there is no standard PCOS treatment. Current options like contraception, lifestyle changes and the diabetes drug Metformin may only help with certain symptoms, which could differ depending on the patient. 

But some health experts see promise in GLP-1s, particularly given their effect on improving weight reduction and insulin sensitivity. 

“The unmet need is huge,” said Dr. Melanie Cree, a pediatric endocrinologist at Kid’s Hospital Colorado. “Primary therapies used for PCOS symptoms have not modified in nearly 50 years.”

Cree has been studying the effect of GLP-1s in adolescents with PCOS for greater than 10 years. She previously studied the oral type of semaglutide and has an ongoing clinical trial on the injectable version, which is what Hamilton participated in for 10 months. 

But her studies are still small as compared to drugmakers’ previous clinical trials on GLP-1s with hundreds of patients. Not all the women who’ve to this point accomplished Cree’s ongoing study lost significant weight, demonstrating that not everyone may reply to GLP-1s.

Novo Nordisk and rival Eli Lilly have been studying their GLP-1s as potential treatments for other chronic conditions like fatty liver disease, but not PCOS. Cree said that is since the Food and Drug Administration has not established specific “endpoints” or goals drugs must meet in clinical trials to display how effective they’re for PCOS. 

In an announcement, a Novo Nordisk spokesperson said the corporate welcomes “independent research investigating the security, efficacy and clinical utility of our products, including semaglutide.” Eli Lilly didn’t immediately reply to a request for comment. 

Conducting longer and bigger trials to raised understand the effect of GLP-1s on PCOS symptoms is crucial, said Sasha Ottey, executive director of the advocacy group PCOS Challenge. It remains to be unclear if GLP-1s may also help address or resolve all PCOS symptoms, or whether the effect differs depending on a patient’s age or the precise drug, Ottey said. 

She added that certain patients may not drop some weight on GLP-1s, and others may not must shed kilos.

Meanwhile, insurance coverage for GLP-1s is a barrier for some PCOS patients, who are sometimes eligible for approved uses of the drugs. Most plans cover GLP-1s for diabetes, but not for obesity or unapproved uses. The drugs can cost roughly $1,000 per thirty days before insurance. Still, Eli Lilly and Novo Nordisk offer significant discounts on their drugs to some patients who pay for it out-of-pocket.

The trial, which began in 2023, follows women and girls ages 12 to 35 with obesity and PCOS who’re on or off Metformin. The study is designed to manage semaglutide to patients for 10 months, and examine their weight reduction, metabolic changes and enhancements in reproductive function. 

Cree hopes the trial will answer whether GLP-1s can improve ovulation in women with PCOS. Many ladies with PCOS don’t ovulate recurrently, which might result in irregular periods and difficulty getting pregnant.

Cree has initial data on 11 women who accomplished the ten months on semaglutide and weren’t on Metformin. She said eight of them lost greater than 10% of their body weight and saw a discount of their testosterone levels. 

Five out of the eight patients had their testosterone levels reach “normal ranges,” Cree said. Meanwhile, six out of the eight patients reported more regular periods. 

Cree said her trial will eventually have data from 40 women, but she remains to be enrolling patients within the group that takes Metformin. She said it can likely take two years before she publishes the primary results from the study, which can concentrate on the differences in outcomes between kids and adults who only received semaglutide. 

She said comparing the groups is crucial because hormones that control growth are released during puberty, which could change how kids reply to GLP-1s. 

Not all women with PCOS will profit from taking a GLP-1. Cree said in her trial, three patients who accomplished 10 months on semaglutide didn’t lose no less than 10% of their body weight. Considered one of those women didn’t drop some weight in any respect, she said. 

Cree said that is consistent with previous studies on GLP-1s in adults with obesity. 

Despite the promise of GLP-1s in improving symptoms, more research can also be needed on PCOS itself, said Dr. Karen Tang, an OB-GYN and founding father of Thrive Gynecology. She said some people can experience hallmark symptoms of the condition, akin to facial hair and pimples, despite the fact that they’ve normal levels of testosterone. 

“There’s still rather a lot that is very much unknown about PCOS and exactly how the disease form of works,” Tang told CNBC. 

Anecdotal evidence suggests GLP-1s may address greater than just weight issues for individuals with PCOS. In a recent survey of 1,700 people by the contraception app Natural Cycles, 64% of girls with PCOS who took a GLP-1 reported more predictable periods, and 20% said their bleeding days were shorter.

Some patients with PCOS can also lose more weight on GLP-1s than those without the condition, said Dr. Kerry Krauss, an OB/GYN and medical director at Natural Cycles, who has PCOS herself.

Research needs to verify those advantages, but she said it gives hope to many PCOS patients who’re frustrated with common treatments for the condition. Those options typically goal only one aspect of PCOS, akin to reducing androgen levels with certain varieties of contraception. 

Tang added that eating regimen and exercise alone often fall wanting addressing symptoms: “A number of people can exercise very aggressively and recurrently or watch what they eat and still struggle with hormone imbalances, weight, and blood sugar.”

That was the case for Haley Sipes, a 31-year-old mother of three based in Western Kentucky who experienced PCOS symptoms for years with out a diagnosis. In 2022, before being diagnosed, she lost 75 kilos over 10 months through eating regimen and exercise alone. 

Her progress stalled in late 2022 despite an intense eating regimen and exercise regimen, and her weight began to fluctuate in 2023. By mid-2024, she had regained about 30 kilos. 

Sipes sought help from her primary care provider and underwent blood work, which revealed she had a hormonal imbalance. Initial efforts to control her hormones with progesterone and testosterone had a limited effect.

Further bloodwork diagnosed Sipes with PCOS and insulin resistance, which she views as the foundation reason for her weight reduction struggles. She recalled bloating, fatigue, low energy, and water retention during earlier efforts to drop some weight.

Despite her history of painful, irregular periods and ovarian cysts since age 10, her providers never mentioned PCOS as a possible diagnosis.

In September 2024, her doctor prescribed Zepbound. Her insurance covered it because of her BMI and prediabetes status.

Sipes said she noticed changes inside the first month: her food cravings quieted, her inflammation decreased, she experienced less joint pain, and her period became less painful and occurred more recurrently. Sipes added that she has not had ovarian cysts since starting Zepbound. 

After around eight months on the medication, she lost greater than 60 kilos. Sipes said those results significantly improved her emotional health.

“All of the symptoms and being chubby won’t look like big things, but when you have got 20 little things which are continually nagging you, then you definitely’re going to be in a nasty mood sometimes,” Sipes said. 

“I’m just a greater version of myself once I’m not controlled by food thoughts and hormonal issues that cause mood swings,” she continued. “My life does feel so rather more enjoyable.”

Sipes plans to proceed taking Zepbound to take care of her results, possibly at lower doses. She noted that more research is required on whether PCOS symptoms can fully resolve.

A couple of-third of employers now cover GLP-1s for each weight reduction and diabetes, while 55% only cover them for diabetes, in response to a recent survey from the International Foundation of Worker Profit Plans. 

In April, President Donald Trump rejected a Biden administration plan that may have required Medicare and Medicaid to cover obesity drugs.

Some patients, like 34-year-old California mom Nabeelah Karim, have turned to other options. 

Karim was diagnosed with PCOS at 19 and took contraception on and off until giving birth in 2021. She said she struggled with hair loss, irregular periods, debilitating cramps, facial hair growth, severe water retention and mood swings. 

Karim said her period symptoms worsened after she gave birth, and in late 2023, she began what can be a painful five-month-long period. Doctors suggested that she drop some weight, take painkillers or return to contraception. 

While Karim lost some weight through eating regimen and exercise, she was eventually prescribed Eli Lilly’s diabetes drug Mounjaro through the digital health startup Noom in April 2024. 

Her long period stopped and symptoms eased inside days, and she or he began to lose more weight over time. 

“It had solved all the issues that I had experienced for years up until that time,” Karim said. 

But her insurance plan never formally approved or denied coverage of Mounjaro, forcing her to pay its greater than $1,000 per thirty days out-of-pocket price. She eventually found a third-party compounding pharmacy that accepted her prescription, allowing her to purchase a less expensive but unapproved version of the drug. 

Karim used that compounded version for six months and continued to experience weight reduction and enhancements to her PCOS symptoms. 

During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. They can be produced on a case-by-case basis when it’s medically crucial for a patient, akin to when they cannot swallow a pill or are allergic to a particular ingredient.

But Novo Nordisk, Eli Lilly and a few health experts have pushed back – and in some cases, taken legal motion – against the practice, largely since the FDA doesn’t approve compounded drugs. The FDA has declared U.S. shortages of each corporations’ drugs over. 

“When people ask about how secure compounded drugs are, the reply I typically give is I do not know,” said Dominguez from USC’s School of Medicine. She said that is unlike branded drugs, which have clearly defined risks and advantages proven in clinical trials.

Hamilton, the 27-year-old patient who took a GLP-1 for PCOS symptoms, has never taken a compounded GLP-1. She is currently appealing her insurer’s denial of semaglutide now that she has accomplished Cree’s trial. 

“My whole life has been an inability to access look after my medical condition, and I’m uninterested in that,” she said. “If anyone would have been capable of provide 11-year-old Grace with this drug, that may have saved me.”