Eli Lilly’s experimental weight-loss pill helped people lose on average 15% of their bodyweight after 36 weeks at the highest dose, in a midstage study. This is comparable to what's been seen with current injectable therapies such as Wegovy for longer durations.
Researchers reported that orforglipron had side effects similar to those of other drugs in the same class known as GLP-1 receptor antagonists. These included nausea, constipation, and vomiting. The study was published in the New England Journal of Medicine on Friday. The results of the Lilly trial were presented at the American Diabetes Conference in San Diego.
As of now, approved weight loss medicines like Novo Nordisk’s Wegovy can be administered as weekly injections. Ozempic by Novo Nordisk, which contains semaglutide (the same active ingredient found in Wegovy), and Lilly's Mounjaro, both approved for Type 2 Diabetes, are used off-label to help with weight loss. Orforglipron belongs to a group of new experimental medicines that target the same GLP-1 but in daily pill form.
Dr. Nadia Ahmad is Lilly's Associate Vice President overseeing the development of chronic weight management drugs.
She said that orforglipron's weight loss didn't plateau after 36 weeks of the trial. Later-stage studies will test the drug longer to determine its full effectiveness.
She said that the 15% weight loss observed with the highest dose of the four tested in the study is important, because it is at this range that 'you can really start to impact some of other complications that plague these obese patients'.
The medicine was tested on 272 people who had an average body weight starting at 108.7 kg, or about 24 pounds. Patients with obesity (defined as a BMI greater than 30) or overweight (defined as a BMI at least 27), and weight-related conditions were enrolled in the trial. The trial compared four different doses, from 12 to45 milligrams. Participants also received counseling on diet, exercise and lifestyle.
The results showed that weight loss ranged between 9.4% and 14.7% at 36 weeks, compared to 2.3% with placebo. The medicine had a positive effect on triglycerides, cholesterol and systolic pressure. Diastolic pressure, which measures pressure between heartbeats, did not change significantly.
The study found that the most common side effects were nausea, constipation and vomiting. The study found that although most side effects were mild to moderate and occurred as participants increased their dosage of the medication, between 10% and 15% stopped taking it because of them.
In the NEJM article, the researchers led by Dr. Sean Wharton from Wharton Medical Clinic noted that the study was intended to determine the best method and dose for later stage studies.
Researchers noted that 91% participants were White. Ahmad stated that it is a goal of Lilly, as well as the entire drug industry to improve diversity in clinical trial. She noted that phase three studies for another Lilly medication have better representation.
Lilly's is one of many experimental weight-loss drugs that are vying to be on the market alongside blockbusters such as Wegovy. Novo Nordisk announced results last month that showed a pill form of semaglutide resulted in a 15% weight loss after 68 weeks. This is similar to Wegovy.
Doctors say that the drug Rybelsus, approved for Type 2 Diabetes, is difficult to take. It has strict rules about not eating or drinking 30 minutes before taking it.
Pfizer is developing two GLP-1 oral drugs. Last month, the company published data on one of these drugs for people with type-2 diabetes. It also caused weight loss in 16 weeks which researchers said was comparable with other drugs in this class. Pfizer's and Lilly's experimental medicines are designed to allow them to be taken either with or without a meal.
Phase 3 trials are still needed to test the medicines at a larger scale, so it could be months or years before they reach the market.