Weight-loss pill ‘works as well as Ozempic’ in new trial

Pharmaceutical company Eli Lilly said its experimental pill worked as well as blockbuster drug Ozempic to lower weight and blood sugar in a trial of diabetes patients, with the company expecting to seek global regulatory approvals this year.

The study is the first of several under way on the pill, orforglipron, and raised hopes of an effective and easy-to-use treatment reaching a market dominated by weight-loss injections.

Eli Lilly is the pharma company behind the experimental weight-loss pill orforglipron.Credit: Bloomberg

Lilly’s phase 3 trial, involving 559 people with Type 2 diabetes, showed they lost about seven kilograms – or nearly 8 per cent of their body weight – over 40 weeks. That compares favourably with Novo Nordisk’s injected drug Ozempic, where diabetic patients on the highest dose lost about 6 per cent of their body weight.

Lilly said weight loss hadn’t 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 per cent. Ozempic lowered blood sugar levels by 2.1 per cent.

The side effects were similar to injectable obesity drugs, including diarrhoea, indigestion, constipation, nausea and vomiting.

However, the company did not release the underlying data from its trial and the results it disclosed had not been examined by outside experts, The New York Times reported.

Lilly shares surged about 14 per cent after the results of the study emerged. US-listed shares of Ozempic maker Novo, down more than 50 per cent over the past year, dipped again on Thursday.

“While Novo had the head start ... this first mover advantage has waned,” BMO Capital Markets analyst Evan Seigerman said in a research note.

Dr C. Ronald Kahn, a professor of medicine at Harvard University and chief academic officer at Harvard’s Joslin Diabetes Centre, told The New York Times that he had many patients who were reluctant to inject themselves. A pill, he said, “would definitely be preferred by most people”.

Several companies are working to develop weight-loss pills, encouraged by estimates that sales of obesity treatments could hit $US150 billion ($235 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 Lilly’s injectable tirzepatide – sold under the brand names Mounjaro for obesity and Zepbound for weight loss – which mimics GLP-1 and a second hormone called GIP, and has demonstrated weight loss of 22 per cent over 72 weeks.

Like Ozempic, orforglipron targets just GLP-1, but unlike hormone-mimicking peptides, it is a synthetic small-molecule drug.

Pills such as orforglipron could mean wider access to effective weight-loss options since the manufacturing is simpler. It does not require injection packaging and does not have to be kept refrigerated.

“It can be easily made in a factory and shipped everywhere,” Dr Sean Wharton – director of the Wharton Medical Clinic in Burlington, Ontario, who enrolled patients in Lilly’s study of orforglipron for obesity – told The New York Times.

Lilly said orforglipron’s safety profile was consistent with other GLP-1s, allaying some worries over a potential stumbling block to sales.

US-listed shares of Ozempic maker Novo Nordisk, down more than 50 per cent over the past year, dipped again on Thursday.Credit: AP

“[The] data is fantastic from an efficacy standpoint,” said Kevin Gade, chief operating officer at Bahl & Gaynor, which owns Lilly shares.

Lilly said it would report data from another trial for the pill for weight management this year. It plans to file for approval with global regulators for weight loss by the end of this year and for diabetes next year.

“While this trial alone is very good, this just bodes extremely well for their trial in obesity patients,” Gade said.

The late-stage trial found that 13 per cent to 18 per cent of patients given the drug experienced nausea across doses, compared with 2 per cent on placebo. The rate for diarrhoea was 19 per cent to 26 per cent and vomiting 5 per cent to 14 per cent.

“These results firmly validate the tolerable profile of orforglipron,” Seigerman said.

On Monday, Pfizer discontinued development of its experimental weight-loss pill danuglipron after a trial patient experienced a potentially 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 per cent of patients on orforglipron’s 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 per cent to 1.6 per cent across doses.

After 40 weeks of treatment in the multi-dose trial, Lilly said once-daily orforglipron showed body weight reductions of 4.7 per cent at 3 milligrams, 6.1 per cent with 12 milligrams and 7.9 per cent with 36 milligrams. Patients on placebo lost 1.6 per cent.

Lilly said it was confident in its ability to launch orforglipron worldwide without supply constraints, if approved.

Reuters