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What is Pfizer’s weight-loss 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 do eat, they feel full sooner, as TODAY.com
previously reported. Semaglutide, the active ingredient in Ozempic and Wegovy, is
also in this class of drugs.
Danuglipron comes in
pill form. Unlike oral semaglutide, which is currently available as the Type 2
diabetes treatment Rybelsus, it doesn’t require fasting before or after taking
the pill.
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Danuglipron was being
tested as both a twice-daily and once-daily pill. Pfizer announced on Dec. 1
that it was discontinuing phase 3 clinical trials of the twice-daily version
due to high rates of adverse side effects. While these were mostly mild, a
large percentage of participants, who had obesity, experienced them: up to 73%
had nausea; up to 47% had vomiting, and up to 25% had diarrhea. Over half of
participants, all adults with obesity, discontinued the medication during the
study.
The company said that it still plans to release data on its
once-daily version of danuglipron next year, which will "inform a path
forward" regarding pursuing approval for the medication.
The clinical trial did find that twice-daily danuglipron led
to "statistically significant" weight loss, the company said:
Participants were down between 8% to 13% of their body weight on average after
32
received a once-weekly 1 milligram injection of semaglutide
lost about 10 pounds in 30 weeks.
Does Pfizer have a weight-loss pill that’s
better than Ozempic?
Danuglipron and
semaglutide are different molecules so the dosages can’t 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 trials were
different studies with different populations so they can’t be directly
compared, McGowan says.
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“Unless you do a
direct head-to-head comparison, you really can’t make any definitive
conclusions,” he adds.
“But what we can say is that the results are in
the same ballpark as what we’ve seen with Ozempic.”
What are the side effects?
The most common side effects of danuglipron were nausea,
diarrhea and vomiting, according to the studies.
McGown says the rates of discontinuation of danuglipron are
"most concerning" because they may mean the drug will "not be
acceptable for widespread use."
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Adverse events that emerged during treatment were the most
common reason for discontinuation, researchers reported in the Pfizer studies.
The most commonly reported adverse events were
gastrointestinal in nature, according to the Pfizer studies. 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.
In comparison, about 7% of patients treated with Wegovy in
clinical trials permanently stopped taking the drug because of adverse
reactions, according to Novo Nordisk, which makes Wegovy, the version of Ozempic
approved for weight loss.
The most common adverse reactions leading patients to
discontinue Wegovy were nausea, vomiting and diarrhea, the company reported. In
all, about 4% of patients stopped taking the drug because of a gastrointestinal
adverse reaction, it noted.
Danuglipron
approval
·
Pfizer is also testing another oral GLP-1 drug
called which would be taken once a day. It’s currently at the phase 2 trial
stage, according to the company’s drug pipeline information.
·
Pfizer is expected to advance only one of the
two drugs into a late-stage trial, Barron’s and Reuters reported.
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What are the pros and cons of
the pill form?
Yancy says this will be helpful for people who wish to avoid
injections, though most of his patients find the once-weekly shots are easy to
perform and not bothersome.
Another advantage is that there’s no requirement for
refrigeration with the pill version, McGowan adds.
A potential downside is that people might forget to take a
daily drug, 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 once-daily 50 milligram dose of oral for 68 weeks lost 15% of
their body weight. The findings are based on results from a phase 3 study that
involved 667 people.
The weight loss was comparable to that achieved with a 2.4
milligram dose of injected once a week in the form of over the same time frame,
the company said in a statement.


