Subscribe to The Post Most newsletter for the most important and interesting stories from The Washington Post.<\/a><\/p>\nIn interviews, doctors warned that using a drug to shrink your body that much will require close medical management – much more than the level of monitoring many people are now getting when taking drugs like Ozempic, Wegovy and Zepbound.<\/p>\n
If approved, the drug called retatrutide would be most appropriate for people that need to lose a lot of weight, they said, those whose \u201cbody mass index\u201d (a calculation using height and weight) is over 40.<\/p>\n
Patients on average lost 70 pounds after 80 weeks at the highest dose in the treatment\u2019s phase 3 clinical trial. And instead of hitting a plateau, which is common for existing drugs, they kept losing pounds. Patients who stayed on the drug for 104 weeks lost 30.3 percent of their body weight.<\/p>\n
Without careful management of nutrition and exercise, losing that much weight poses risks to bone density and muscle mass, experts said.<\/p>\n
\u201cWhat did Spider-Man say? \u2018With great power comes great responsibility.\u2019 That\u2019s the case with this drug,\u201d said John Morton, a professor at Yale medical school and medical director of bariatric surgery at Yale New Haven Health System.<\/p>\n
Retatrutide shows how doctors and patients will ultimately have a variety of drugs with different potencies to choose from, depending on their weight-loss goals and other health factors.<\/p>\n
\u201cThis would not be for someone who wants to lose 15 to 20 pounds. This is for patients who are much heavier,\u201d Morton said.<\/p>\n
Eli Lilly did not provide specific answers to questions about the risks of too much weight loss.<\/p>\n
\u201cWhat constitutes healthy weight loss should be guided by patients\u2019 needs, goals, and overall health in consultation with their healthcare providers,\u201d an Eli Lilly spokesperson said in an email. \u201cRetatrutide is investigational, and decisions about which doses may be available will be determined through the regulatory review process.\u201d<\/p>\n
The company plans to release the full trial results in June at a conference of the American Diabetes Association. The top-line weight-loss results were contained in a press release issued on May 21, which compared the results favorably to bariatric surgery, a single procedure to treat obesity by shrinking a patient\u2019s stomach.<\/p>\n
Severely restricting calorie intake does not just reduce fat reserves. It also can weaken bones and reduce muscle mass, as the body adapts to make up the nutrition deficit.<\/p>\n
Retatrutide\u2019s greater potency poses other dangers as well, said Eric Topol, a cardiologist and founder of the Scripps Research Translational Institute, including electrolyte imbalances, gallstones, a compromised immune system and hormone disruptions.<\/p>\n
\u201cThere\u2019s a lot of things here that can go wrong when you lose that much weight,\u201d Topol said.<\/p>\n
Eli Lilly said loss of muscle mass \u201cis a normal part of weight loss with most interventions, including lifestyle changes, medications and bariatric surgery. We have not observed concerning signs of muscle weakness in clinical trials to date.\u201d<\/p>\n
The company said 11.3 percent of patients on the highest dose during retatrutide\u2019s clinical trial stopped taking the drug during the study because of significant side effects: nausea, diarrhea, constipation, vomiting and upper respiratory tract infection.<\/p>\n
Many people taking existing GLP-1 drugs – semaglutide (Ozempic, Wegovy) and tirzepatide (Zepbound) – stop taking them at some point. A recent study by researchers at the Cleveland Clinic found that almost half of the people who started the drugs stopped because of financial reasons (many insurance carriers do not cover them) and 14.6 percent stopped because of side effects.<\/p>\n
When people halt the drugs, they typically regain whatever weight they lost, studies have found. High cholesterol, blood pressure and other risk factors for chronic illnesses also rebound.<\/p>\n
The active ingredient in Ozempic and Wegovy, made by Novo Nordisk, mimics a natural gut hormone called GLP-1. It sends signals to the brain that make a person feel full and reduces appetite. Patients on average achieved 15 percent weight loss in its clinical trial.<\/p>\n
Eli Lilly\u2019s Zepbound contains a GLP-1 plus another peptide that mimics a gut hormone, GIP, which stimulates insulin secretion. In its clinical trial, patients achieved 21 percent weight loss at the highest dose.<\/p>\n
For retatrutide, to get to 28 percent weight loss on average, Eli Lilly added a third component, glucagon, which regulates glucose.<\/p>\n
\u201cWhen you put all three together, you are seeing these spectacular results,\u201d said Bharti Shetye, president-elect of the Obesity Medicine Association and founder of Dr. Abby\u2019s Weight Management Clinic, in Tampa. \u201cSeeing this 28 to 30 percent weight loss, it\u2019s mind-blowing.\u201d<\/p>\n
It will be many months before the drug can reach the market. Eli Lilly said trial results will be presented at medical meetings and published in peer-reviewed journals. The company expects to submit its findings to the Food and Drug Administration by the end of 2026, a spokesperson said in an email Thursday, which means the earliest potential approval date would likely be in 2027.<\/p>\n
The promise of retatrutide to deliver enhanced results has led to unregulated copies being sold on the internet, for \u201cresearch\u201d purposes, even before the brand-name has been approved by the FDA.<\/p>\n
Without significant doctor supervision and through an uncontrolled supply chain, Shetye and others said, those patients are essentially experimenting on themselves.<\/p>\n
Shetye said someone recently told her about an acquaintance who was purchasing unapproved retatrutide.<\/p>\n
\u201cI looked at him and said, \u2018Is your friend a hamster?\u2019\u201d she said. \u201cIt\u2019s scary.\u201d<\/p>\n
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