Eli Lillyâs experimental pill worked as well as blockbuster drug Ozempic to lower weight and blood sugar in a trial of diabetes patients, and the company said it expects to seek regulatory approvals by the end of the year.
Shares jumped 16 percent as results of the study, the first of several underway on the pill, orforglipron, raised hopes of an effective and easy-to-use treatment reaching a market dominated by weight-loss injections.
US-listed shares of Ozempic maker Novo Nordisk, down more than 50 percent over the past year, fell another 7 percent on Thursday. âWhile Novo had the headstart … this first mover advantage has waned,â BMO Capital Markets analyst Evan Seigerman said in a research note.
Lillyâs phase 3 trial showed that type 2 diabetes patients lost 16 pounds, or nearly 8 percent of their body weight, over 40 weeks. That compares favourably with Novoâs injected drug Ozempic, where diabetic patients on the highest dose lost roughly 6 percent of their body weight.
Lilly said weight loss hadnât plateaued at the time the study ended, suggesting that patients might lose more weight. The pill lowered blood sugar levels by an average of 1.3 percent. Ozempic lowered blood sugar levels by 2.1 percent.
Several companies are working to develop weight-loss pills, encouraged by estimates that sales of obesity treatments could hit $150 billion in the coming years. The latest data puts Lilly firmly in the lead in the race for effective oral drugs that can compete with injections.
Ozempic, approved for diabetes in 2017, is designed to target an intestinal hormone called GLP-1.
It competes with Lillyâs injectable tirzepatide â sold under the brand names Mounjaro for obesity and Zepbound for weight loss â which mimics GLP-1 and a second hormone called GIP, and has demonstrated weight loss of 22 percent over 72 weeks.
Like Ozempic, orforglipron targets just GLP-1, but unlike hormone-mimicking peptides, it is a synthetic small molecule drug.
Readily Manufactured
Pills such as orforglipron could mean wider access to effective weight-loss options since the manufacturing is simpler.
Lilly said orforglipronâs safety profile was consistent with other GLP-1s, allaying some worries over a potential stumbling block to sales.
The âdata is fantastic from an efficacy standpoint,â said Kevin Gade, chief operating officer at Bahl & Gaynor, which owns Lillyâs shares.
Lilly said it would report data from another trial for the pill for weight management later in the year. It plans to file for approval with global regulators for weight loss by the end of this year and for diabetes next year.
âWhile this trial alone is very good, this just bodes extremely well for their trial in obesity patients,â said Gade.
The late-stage trial found that 13 percent to 18 percent of patients given the drug experienced nausea across doses, compared with 2 percent on placebo. The rate for diarrhea was 19 percent to 26 percent and vomiting 5 percent to 14 percent.
âThese results firmly validate the tolerable profile of orforglipron,â Seigerman said.
On Monday, Pfizer discontinued development of its experimental weight-loss pill danuglipron after a trial patient experienced potential drug-induced liver injury that resolved after the medication was stopped.
Lilly said no liver-related safety signal was observed in its trial.
The company said 8 percent of patients on orforglipronâs highest dose discontinued treatment due to adverse events.
Levels of HbA1c, a measure of blood sugar over time, fell by an average of 1.3 percent to 1.6 percent across doses.
After 40 weeks of treatment in the multi-dose trial, Lilly said once-daily orforglipron showed body weight reductions of 4.7 percent at 3 mg, 6.1 percent with 12 mg, and 7.9 percent with 36 mg. Patients on placebo lost 1.6 percent.
Lilly said it was confident in its ability to launch orforglipron worldwide without supply constraints, if approved. The company recorded $550 million related to the drugâs inventory in its financial statements in February.
By Bhanvi Satija, Manas Mishra, Christy Santhosh and Deena Beasley; Edited by Shinjini Ganguli, Sriraj Kalluvila and Diane Craft
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