A daily weight loss pill from Novo Nordisk was shown to lower body weight by up to 13% after three months in a Phase 1 clinical trial, according to findings presented Tuesday at the European Association for the Study of Diabetes annual meeting in Spain.
The rate of weight loss with the experimental pill, called amycretin, appears to be more rapid than what’s seen for other drugs.
“It’s roughly double the weight loss rate seen with current GLP-1 agonists and approaching procedural or surgical-level outcomes,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in North Carolina. “It shows potential promise.”
Dr. Susan Spratt, an endocrinologist and the senior medical director for the Population Health Management Office at Duke Health, said the results looked impressive.
"How could they achieve weight loss that quickly?" Spratt asked. "It's almost like a miracle pill."
The findings are early — more research is needed, particularly over a longer period of time — and the drug can’t be directly compared to existing weight loss drugs because they weren’t tested in a head-to-head trial. The results also haven’t been published in a peer-reviewed journal.
Martin Lange, executive vice president and head of development at Novo Nordisk, said in a statement that amycretin works in a similar way to semaglutide, the drug in Wegovy and Ozempic. It’s a GLP-1 agonist, which mimics a hormone that helps reduce food intake and appetite. However, it also imitates a second hormone, called amylin, which can also promote a feeling of fullness.
Tuesday’s results were based on a Phase 1 clinical trial of adults who were overweight or had obesity who got either amycretin or a placebo daily for up to 12 weeks. Researchers also tested multiple doses of the drug, including increasing some participants’ dose levels over time.
The goal of a Phase 1 trial is to look at the safety of a new drug, including determining what doses work best for patients. Later trials focus on how well the drug works.
That having been said, people who got the weight loss drug did lose weight: After 12 weeks, participants on the highest dose had lost an average of 13.1% of their body weight, compared with an average loss of 1.1% of body weight among those taking a placebo.
Novo Nordisk said the drug appeared to be safe, with side effects in line with those of Ozempic and Wegovy. Common side effects of those drugs can include nausea, diarrhea, stomach pain and vomiting.
Lange said the drugmaker has started a Phase 2 trial in people with Type 2 diabetes.
How much weight loss is too much?
McGowan said that while the weight loss was significant, he still has concerns about how fast people lost weight.
“While losing weight is seemingly the end goal, how that weight is lost matters,” he said. “Patients losing weight in a healthy, sustainable manner will be far more likely to maintain their weight and preserve lean mass.”
He also said he wanted more details about the side effects patients experienced while they were on the pill, which could provide more insight.
“Did patients lose weight more rapidly because they were less hungry or because they were sick?” McGowan said.
Spratt said she would like to know how much of the weight loss came from fat compared with muscle.
"Muscle actually helps you metabolize glucose," the body's primary source of energy, she said. "Physicians worry about [losing] muscle mass, especially in their elderly patients."
She also had questions about dropout rates in the trial, details that would most likely be shared if the results are published in a journal.
"How are they losing so much weight? How much nausea and vomiting are there?" she asked.
