- Novo Nordisk is testing a new pill for weight loss that could be more effective than GLP-1 injectable drugs like Ozempic and Wegovy.
- The drug, amycretin, led to a 13% reduction in body weight in a small phase I trial.
- Experts caution the drug may not prove to work in future studies and that more research is needed.
The drug manufacturer Novo Nordisk is developing an experimental weight-loss pill to treat obesity that may lead to more significant weight loss than injectable GLP-1 medications like Ozempic and Wegovy.
On September 11, the Danish company said its weight loss drug amycretin was safe and tolerable with mild to moderate side effects, Reuters reported.
Earlier this year, Novo Nordisk released data from the trial demonstrating that the medication, a GLP-1 and amylin co-agonist, was associated with a 13% reduction in body weight in three months. Compared to a placebo, the reduction was considered significant.
The results from the trial have not yet been published in a peer-reviewed journal, but the researchers presented the results at the 60th annual meeting of the European Association for the Study of Diabetes (EASD) September 9–13 in Madrid, Spain.
Having a pill available that’s as safe and effective as the current GLP-1 medications, which are administered by an injection, would make using and accessing weight-loss medications easier for people with obesity.
While the results from Novo Nordisk’s trial are promising, more data is needed to better understand the efficacy and safety of amycretin, including how it compares to other weight-loss drugs like Wegovy.
“The data are exciting, but do not tell us how this medicine works in diverse populations, in people with different conditions, nor does it give us information on the long-term effects on a person’s health,” Shiara Ortiz-Pujols, MD, an obesity medicine physician at Staten Island University Hospital, told Healthline in an earlier interview. Ortiz-Pujols was not involved in the research.
According to Novo Nordisk, the phase I trial was conducted in the first quarter of 2024.
“This was an early-stage trial involving a total of 144 patients designed to examine the safety, tolerability and pharmacokinetics of amycretin to inform further clinical development, and the change in body weight was an exploratory endpoint in the trial,” Novo Nordisk said in a statement provided to Healthline.
The trial showed that in a cohort of 16 people with a mean baseline body weight of 89 kilograms or 196 pounds, subjects, on average, lost 13.1% of their body weight in the course of 12 weeks.
The adverse events were similar to those observed with other GLP-1 medications produced by Novo Nordisk.
“The pharmacokinetic profile of amycretin allows for further development and we look forward to progressing it through larger clinical trials in the coming years,” Novo Nordisk’s statement said.
“Having a pill available that is just as effective — or more effective — would certainly make using these medications easier for the patient,” Mir Ali, MD, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, told Healthline. Ali is not involved in the research.
The first step in testing a new treatment designed for humans is to conduct a phase I trial.
“The goal of phase I is to understand safety, not effectiveness,” Ortiz-Pujols said.
Following the phase I trial, additional research is conducted to investigate long-term side effects and effectiveness.
“It would be important to see if amycretin is effective alone and long-term effects,” Ali said. “Therefore, more data is needed to reach further conclusions.”
Phase II trials evaluate the effectiveness and safety in a larger cohort of people, between 100 to 300 individuals.
Phase III trials test the drug in roughly 1,000 to 3,000 participants to confirm the findings from the initial trials.
“It takes several years of further study between Phase I and Phase III studies,” said Ortiz-Pujols.
Finally, phase IV trials, which occur after the medication receives approval for use from the Food and Drug Administration (FDA), continue to monitor the drug in the general population.
Ortiz-Pujols said future clinical trials could examine the gastrointestinal tolerability of the pill since this is a major issue people experience with the current injectables and if weight regain occurs when people discontinue the drug.
Ortiz-Pujols added the trials will investigate how the pill compares to the GLP-1 drugs currently available and whether there are any heart or liver benefits.
“Much more investigation is necessary before we can truly understand the potential of a medication,” she concluded.
Novo Nordisk is testing a new weight-loss pill, called amycretin, that is said to lead to faster, more significant weight loss than currently approved GLP-1 injectable medications like Wegovy.
Having a pill available that’s as safe and effective as the GLP-1 medications administered by an injection would make using and accessing weight-loss medications easier for people with obesity. The drug has only been tested in a very small group of people and much more research is needed to better understand the effectiveness and safety.