People who were overweight or had obesity lost a substantial amount of weight after taking a daily bill made by Eli Lilly, the company reported on Wednesday. The pharmaceutical manufacturer will be applying to the Food and Drug Administration by the end of this year for marketing approval for the medication, which would provide an alternative to injectable drugs that produce weight loss and are already on the market.
Eli Lilly plans “a large investment,” in manufacturing the drug, orforglipron, said Kenneth Custer, executive vice president at Lilly and president of Lilly Cardiometabolic Health
The company reported its results in a news release, as drug companies are required to do immediately after they receive study data that could affect their stock price. But the data are not a full report and have not been examined by outside experts. Eli Lilly says it will publish detailed results later this year.
The company studied orforglipron in 3,127 adults who were randomly assigned to take one of three doses of the drug or to take a placebo for 72 weeks. It is a GLP-1 drug, like the popular injected weight-loss and diabetes drugs Ozempic and Wegovy, made by Novo Nordisk. Lilly’s injected drugs, Mounjaro and Zepbound, have one additional ingredient.
Those taking the highest dose of orforglipron lost an average of 27.3 pounds, or 12.4 percent of their body weight. They also reduced their levels of cholesterol, triglycerides, and blood pressure.
Like the already approved injected weight-loss drugs, orforglipron’s side effects were mostly gastrointestinal — constipation, diarrhea, vomiting and indigestion.
In April, Lilly announced results from a similar study of orforglipron in people with type 2 diabetes, reporting that the drug lowered blood sugar and was about as effective as Ozempic in eliciting weight loss in these patients. The company said it would seek F.D.A. approval to market the drug for diabetes in 2026.
Orforglipron has not been directly compared with Wegovy or Zepbound. But both of those drugs may give greater weight losses than the pill. In one study comparing those two drugs, people taking Zepbound lost 20.2 percent of their weight and those taking Wegovy lost 13.2 percent over 72 weeks.
But, Dr. Custer, noted, the pill has distinct advantages over injected drugs. The injected obesity drugs are sterile solutions that must be kept cold. After the solutions are made they must be put into pens or vials — a “capital intensive” step, Dr. Custer noted. He said 170 million Americans might benefit from obesity drugs, but just eight million are taking them now. That, he said, is largely a result of “production limitations.”
Pills, in contrast, are easy to make and “can be manufactured at a significant scale,” Dr. Custer said. “There are orders of magnitude differences in how many we can support.” And the pills can be used in countries that are unable to supply cold sterile drugs to large numbers of people.
Dr. David Cummings, an expert in obesity medicine at the University of Washington, said the ease of manufacturing the pills could be their main advantage. They do not appear to be as effective as injected drugs in helping people lose weight, he noted.
But if the pill is marketed at a far lower cost, he said, “that feature alone could make it truly impactful.”
During his confirmation hearing as health secretary, Robert F. Kennedy Jr. called the injectable obesity and diabetes medications “miracle drugs,” a shift from previous critical remarks he had made about the drugs and their manufacturers.
Eli Lilly will not be announcing a price for orforglipron before it is approved for marketing.
Gina Kolata reports on diseases and treatments, how treatments are discovered and tested, and how they affect people.
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