Weight loss with Ozempic or Wegovy requires patients to inject themselves with the drug, and drawbacks have been reported for some people. But a new oral drug from Pfizer promises to deliver similar results, minus the needle.
While some headlines have already heralded it as potentially the next Ozempic in pill form and easier to use than similar treatments, experts say it’s still early in the process to say for sure.
It needs to be studied on a larger scale and for a longer duration before we can truly understand its true impact, Dr. Christopher McGowan, an obesity medicine specialist in Cary, North Carolina, told TODAY.com. McGowan was not involved in the Pfizer study.
The important thing is that patients can take it orally rather than an injection, patients would always prefer to take something orally in general.
Patients also need more options when it comes to diet drugs, so a new drug would be welcome, adds Dr. William Yancy, medical director of Duke Lifestyle and Weight Management Center, in Durham, North Carolina. he was also not involved in the study.
No. 1, could bring down prices, which are still very high, Yancy says. No. 2, the pill form may be preferable for some patients. No. 3, the side effects can be different.
But it could be years before the new drug gets approval and becomes commercially available, McGowan notes.
What is Pfizer diet drug?
Known as danuglipron, the diabetes and obesity treatment is in a class of drugs called GLP-1 agonists and mimics a hormone the body releases when a person eats food. People have reduced appetite, and when they eat, they feel full sooner, TODAY.com previously reported. Semaglutide, the active ingredient in Ozempic and Wegovy, is also in this drug class.
Danuglipron comes in pill form. Unlike oral semaglutide, which is currently available as a treatment for type 2 diabetes Rybelsus, does not require fasting before or after taking the pill, researchers reported in the results of the Pfizer-sponsored danuglipron test study.
When people took danuglipron twice a day for four months, their body weight was statistically significantly reduced compared with a placebo, according to a phase 2 randomized clinical trial involving 411 adults with type 2 diabetes. findings were published on JAMA Network in May 2023.
Study participants who took the highest dose of danuglipron 120 milligrams twice a day lost about 10 pounds over 16 weeks, the researchers reported. The paper didn’t directly compare these results to Ozempic or Wegovy, but a Phase 3 study showed patients who received a once-weekly 1-milligram injection of semaglutide lost about 10 pounds in 30 weeks.
Does Pfizer have a better diet pill than Ozempic?
When it comes to effectiveness, it’s a bit early to tell, McGowan notes.
Danuglipron and semaglutide are different molecules, so dosages cannot be directly compared, but in general, the oral dose required to achieve the same results as an injectable version is significantly higher because the digestive tract is a more challenging route for absorption McGowan says.
The studies were different studies with different populations, so they can’t be compared directly, McGowan says.
Unless you do a direct head-to-head comparison, you can’t really draw any firm conclusions, he adds.
But what we can say is that the results are on the same level as what we have seen with Ozempic.
What are the side effects?
The most common side effects of danuglipron were nausea, diarrhea and vomiting, according to the study.
Most concerning to me is that there was a drug discontinuation rate of up to 34 percent at the highest doses and that would not be acceptable for widespread use, McGowan says.
Treatment-emergent adverse events were the most common reason for discontinuation, researchers reported in the Pfizer study. They noted that the study involved rapid increases in the drug dose, which likely impacted optimal tolerability assessments, leading to higher discontinuation rates.
It’s possible that more gradual dosing could reduce the severity of side effects, McGowan adds.
The most commonly reported adverse events were gastrointestinal in nature, according to the Pfizer study. They were mild, more common with higher doses, and known to be associated with GLP-1 agonists, Pfizer said in a statement to TODAY.com.
By comparison, about 7 percent of patients treated with Wegovy in clinical trials permanently stopped taking the drug due to adverse reactions, according to Novo Nordisk, which makes Wegovy, the approved weight-loss version of Ozempic.
The most common adverse reactions that led patients to discontinue Wegovy were nausea, vomiting and diarrhea, the company reported. In all, approximately 4% of patients discontinued the drug due to a gastrointestinal adverse reaction.
Danuglipron approval
Pfizer’s product was still years away, McGowan says.
Pfizer is also testing another oral GLP-1 drug called lotiglipron, which would be taken once a day. It is currently in Phase 2 trials, according to the company’s drug pipeline information.
Pfizer is expected to advance just one of the two drugs in a late-stage study, Barrons and Reuters reported.
Pfizer has not confirmed those reports to TODAY.com.
What are the pros and cons of the pill form?
Yates says this will be helpful for people who want to avoid injections, although most of his patients find once-a-week injections easy to do and not bothersome.
Another plus is that there’s no need for refrigeration with the pill version, adds McGowan.
One potential downside is that people may forget to take a daily medication. How consistently can patients take it over time? It’s not easy to remember to take a drug twice a day, every day, potentially forever, he notes.
Are there other pill forms of GLP-1 for weight loss?
In May 2023, Novo Nordisk announced that obese or overweight adults who took a daily dose of 50 milligrams of oral semaglutide for 68 weeks lost 15 percent of their body weight. The findings are based on results from a Phase 3 study involving 667 people.
The weight loss was comparable to that achieved with a 2.4-milligram dose of semaglutide injected once a week in the form of Wegovy over the same time frame, the company said in a statement.
Oral semaglutide appears to be safe and well tolerated, with the most common side effects described as mild to moderate gastrointestinal adverse events, the statement added.
Patients should take the drug on an empty stomach first thing in the morning with a drink of water and then wait 30 minutes before they can eat or drink, similar to the directions for Rybelsus, a spokeswoman for Rybelsus told TODAY.com. Novo Nordisk. Pfizer’s danuglipron does not have these restrictions, the JAMA Network study authors noted.
In its statement, Novo Nordisk says it expects to apply for regulatory approval in the United States this year.
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