Lilly’s oral GLP-1 agonist gains ground on injectables

Eli Lilly’s oral GLP-1 agonist has demonstrated efficacy and safety comparable to injectable GLP-1 therapies in type 2 diabetes, according to the ACHIEVE-1 trial data presented at the American Diabetes Association (ADA) congress.

The company is preparing to engage with the Therapeutic Goods Administration (TGA) to make once-daily oral orforglipron available to eligible Australians. When approved, the oral therapy could mark a major shift in type 2 diabetes care for the 1.3 million Australians currently living with the chronic disease.

“The reduction in blood glucose and weight with orforglipron is similar, if not a little bit better, than the similar clinical trials that were done for Ozempic and Mounjaro,” said Professor Sof Andrikopoulos, CEO of Australian Diabetes Society (ADS).

In the phase 3 ACHIEVE-1 trial, orforglipron reduced HbA1c by an average of 1.3% to 1.6% across doses, with results visible as early as four weeks. A key secondary endpoint revealed a 7.9% weight reduction, equivalent to 7.3 kg (16.0 lbs), at the highest drug dose by week 40.

Crucially, Lilly also spotlighted the absence of liver toxicity, an adverse event that recently ended Pfizer’s development of its rival oral GLP-1, danuglipron. That distinction strengthens orforglipron’s profile in an increasingly competitive therapeutic area.

Another point of difference is convenience. Unlike injectable GLP-1 therapies or other oral semaglutides, orforglipron comes without the need for food or water restrictions, a practical advantage for the many patients who prefer oral medications.

“These clinically meaningful findings will accelerate the momentum generated by the research and real-world use of injectable medicines that activate key hormones to regulate blood sugar and appetite,” said Tori Brown, General Manager, Eli Lilly Australia & New Zealand.

With type 2 diabetes diagnoses having tripled over the last 20 years, and now affecting 5.3% of the Australian population, there is growing urgency to broaden therapeutic options.

“We look forward to working with the Federal Government to ensure the latest innovative medicines are available to Australians living with type 2 diabetes,” added Brown.

The momentum isn’t slowing. Lilly is on track to deliver topline results later this year from two key head-to-head trials: ACHIEVE-2 (comparing orforglipron with dapagliflozin) and ACHIEVE-3 (comparing orforglipron with oral semaglutide), both involving patients whose type 2 diabetes is inadequately controlled with metformin.

Also underway are the ATTAIN-1 and ATTAIN-2 trials, which include Australian clinical sites. These studies are evaluating orforglipron in patients with obesity / overweight and type 2 diabetes, with data expected in the third quarter of this year.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.