The drugmaker says it needs more time to finish manufacturing and quality-control data for regulators
By
Freschia Gonzales
Jul 27, 2026
Eli Lilly will wait until the first quarter of 2027 to seek US approval for retatrutide, its next-generation obesity injection, pushing back a filing it had earlier expected to lodge this year.
The company told CNBCit needs more time to gather and verify the manufacturing and quality-control data that regulators require before it can apply.
Lilly said on Thursday that two more late-stage trials of the weekly shot had succeeded lifting to five the number of positive Phase 3 studies behind the drug.
One of those trials, TRIUMPH-2, tested retatrutide in adults who had both type 2 diabetes and obesity or overweight, a group CNBCnoted typically struggles to lose weight.
Participants on the highest dose shed an average of 20.8 percent of their body weight, or nearly 50 pounds, over 80 weeks, and cut a key blood-sugar measure, A1C, by up to 1.6 percent.
The second trial, TRIUMPH-3, enrolled adults with severe obesity and established cardiovascular disease, with or without diabetes.
Those on the top dose lost an average of 22.6 percent of their weight, or 55.8 pounds, at 80 weeks, as per Lilly.
Retatrutide sets itself apart from existing treatments by acting on three metabolic hormones rather than one or two.
Reutersreported that the drug targets GLP-1, GIP, and glucagon, whereas Lilly’s current injection Zepbound hits GLP-1 and GIP, and rival Novo Nordisk’s Wegovy targets GLP-1 alone.
Analysts said the fresh data did little to change the drug’s trajectory.
“The weight-loss results are no longer headline-grabbing given prior retatrutide data, but further strengthen its position within Lilly’s expanding cardiometabolic portfolio,” Citi analysts said
The cardiovascular findings drew closer scrutiny.
Lilly said major adverse cardiovascular events occurred less often than expected in both the treatment and placebo groups.
When narrowed to the three most serious outcomes, heart attack, stroke, and death, patients on retatrutide carried a 12 percent higher risk than those on placebo, Reutersreported; Lilly’s release put the hazard ratio for that measure at 1.12.
BMO Capital analysts called the dataset limited and the imbalance hard to interpret, though they said the directional benefit among patients who stayed on treatment was encouraging.
Nausea, diarrhea, and constipation ranked among the most common side effects in both trials, the company said, consistent with the wider GLP-1 class.
TD Cowen analysts estimated retatrutide could generate US$3.8bn in sales by 2030, CNBCreported, while some analysts peg the broader weight-loss and diabetes market at roughly US$100bn by the 2030s.
Lilly shares fell about 1 percent in premarket trading on Thursday, as per Reuters.
Retatrutide showed efficacy across “five positive Phase 3 studies,” said Kenneth Custer, president of Lilly’s cardiometabolic health unit, in a statement.
The latest results give Lilly the clinical data package to support global submissions for retatrutide as a treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea, he said.
Lilly had already reported that patients with obesity but not diabetes lost an average of 28.3 percent of their weight over 80 weeks, and it has posted positive Phase 3 results for the drug in knee osteoarthritis pain and obstructive sleep apnea.
Full results from the two latest trials will appear at medical meetings and in peer-reviewed journals at a later date, the company said.
