If approved by the FDA, the oral medication danuglipron could be a game changer for people who want to lose weight but don't like injections.
Ozempic and Wegovy — made by Novo Nordisk — are in high demand due to their remarkable ability to help people lose weight quickly. Both drugs contain semaglutide — a medication designed to treat type 2 diabetes.
Semaglutide is a glucagon-like peptide-1 (GLP-1) agonist that helps lower blood sugar levels and makes a person feel full by slowing the rate food travels through the digestive tract. And these actions can result in weight loss.
However, a person must inject Ozempic and Wegovy once a week into their leg, lower stomach, or upper arm.
Despite Novo Nordisk's immense success with semaglutide, the pharmaceutical giant may soon have a rival to contend with in the weight loss arena.
Phase 2 clinical trial results of Pfizer's new oral type 2 diabetes drug danuglipron — also a small molecule GLP-1R agonist — showed that people with type 2 diabetes taking 120mg of the drug twice daily lost an average of 10 pounds by 16 weeks.
The results, published on May 22 in JAMA Network, suggest Pfizer's pill may be as effective for weight loss as Ozempic.
During the trial, 411 adult participants with type 2 diabetes took either a placebo or an escalating dose of danuglipron twice a day with food for 16 weeks.
The researchers gradually increased the pill's dosage to 40mg or more, taken twice daily.
At 16 weeks, all participants taking danuglipron experienced significant reductions in blood glucose. In addition, participants taking 80mg and 120mg twice daily lost weight. Specifically, those in the 120mg group lost close to 10 pounds on average.
Still, those taking less than 80mg did not experience significant weight loss.
Though the trial did not compare Pfizer's drug to Ozempic, weight loss at higher doses was similar to that observed in a semaglutide phase 2 trial.
According to the study, the most common side effects reported were nausea, diarrhea, and vomiting. Moreover, though the rates of nausea and diarrhea were similar among those taking 80mg twice per day, the rate of vomiting was higher in the 120mg twice daily group.
If it gains FDA approval, Pfizer's new medication could be an injection-free option for treating type 2 diabetes and obesity.
What are possible concerns with these weight loss drugs?
Despite the fanfare over Ozempic, Wegovy, and other weight loss medications, they have also caused controversy among scientists and the general public about their potential negative and positive effects.
For example, reports suggest that Ozempic may cause malnutrition, and some people using Ozempic and Wegovy say the drugs cause hair loss. Still, other studies say that Ozempic may lower the risk of heart attack and fight cancer.
In addition, although these medications help people lose weight in the short term, a 2022 study found that one year after discontinuing semaglutide, study participants regained most of the weight they lost. The authors say this indicates that ongoing treatment is required to maintain the improvements in weight and health gained from taking these drugs.
- JAMA Network. Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial.
- Diabetes, Obesity and Metabolism. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension.