New diabetes drug may outperform Ozempic jab
The first diabetes and obesity pill that works like Ozempic — but in tablet form — may actually outperform the injectables drugs.
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The first diabetes and obesity pill that is similar to Ozempic — but in tablet form — may actually outperform the popular injectables drugs.
Eli Lilly research shows their new GLP-1 pill successfully lowered patient’s weight and blood sugars, with some patients responding so well their levels no longer met the threshold for diabetes.
This is the first time a GLP-1 pill — expected to be more affordable and accessible than current injectable options — has successfully completed a large, human trial.
The peer-reviewed results were published in the New England Journal of Medicine and shared at the American Diabetes Association Scientific Sessions conference in the United States this weekend.
Eli Lilly confirmed they will use the findings to seek approval of the once-a-day, prescription drug, called orforglipron, for type II diabetes treatment in Australia.
The study found the most common adverse effects were mild to moderate gastrointestinal events.
Between 4.4 and 7.8 per cent – depending on the dose – of patients stopped taking the drug because of side effects, compared to 1.4 per cent of patients in the placebo group.
A top Australian diabetes expert, who attended the conference, said we were on the cusp of a new era for treating the disease and even more options were on the horizon.
Australian Diabetes Society chief executive Associate Professor Sof Andrikopoulos said there were 50 other GLP-1 pills in various stages of clinical development.
“[Orforglipron] is like a chemical, it does a similar job as Ozempic or Mounjaro, but it’s in pill form,” he said.
“There’s at least another 50 different types of therapies coming on within this class.
“It’s so exciting, it’s so unbelievably good for the person with diabetes, the person with overweight and obesity, that there will be choice, that there will be therapies that will have really enormous benefits.
“I think we’re right at the cusp, at the dawn of therapies that will really change the course of the disease.”
The international study involved 500 adults with type II diabetes and found different orforglipron doses lowered their A1C — a common test to measure blood sugar — by a statistically significant amount compared to the placebo group.
Patients on the highest dose lost an average of 7.25 kgs after 40 weeks and two-thirds recorded A1C levels below the standard threshold — 6.5 per cent — for type II diabetes.
Assoc Prof Andrikopoulos said at this stage “you’re getting the point where you’re no longer having type II diabetes”.
“By reducing your AIC you are preventing or delaying the onset of cardiovascular disease, of chronic kidney disease, of strokes, of blindness, of foot ulcers and amputations,” he said.
“You’re getting rid of those complications which is ultimately what kills a person with type II diabetes.”
He said participants lost more weight compared to patients in some similar studies on Novo Nordisk’s Ozempic, so orforglipron may be actually be more effective than the popular diabetes jab.
He said the two drugs would need to be compared head to head in the same trial to confirm this, but the pill was beneficial regardless as it did not need to be refrigerated and was easier to manufacture.
“It will make GLP-1 based therapies or therapies like Ozempic, Mounjaro more accessible and more affordable,” he said.
“With injectables there’s logistics considerations, for example keeping the supply refrigerated.”
Eli Lilly said in a statement they were also researching orforglipron’s use as a treatment for obesity and other metabolic conditions.
Eli Lilly Australia and New Zealand general manager Tori Brown said they “look forward to working with the Federal Government to ensure the latest innovative medicines are available to Australians living with type II diabetes”.
“These clinically meaningful findings will accelerate the momentum generated by the research and real-world use of injectable medicines that active key hormones to regulate blood sugar and appetite,” she said.
Several injectable GLP-1 medications have been approved in recent years in Australia to treat both type II diabetes and obesity, but access has been an ongoing issue.
Soaring rates of off-label prescriptions for weight-loss have sparked significant shortages, while the significant cost of the medications has been a barrier for many.
Some GLP-1 drugs approved by the TGA have not been added to the Pharmaceutical Benefits Scheme, as the scheme’s advisory committee did not find the benefits justified the high cost.
Prof Andrikopoulos said he expected the drug would be approved by the TGA, and believed it had a better shot at PBS approval too because of its expected lower cost.
The news comes shortly after Novo Nordisk released results from early stage research on their new obesity drug — which is being developed in pill plus injectable form — and said larger, human trials would begin next year.
A Therapeutic Goods Administration spokesman said they were aware of ongoing trials for a “number” of GLP-1 agonist products.
“Generally, for products to be supplied In Australia, a sponsor (usually a pharmaceutical company, and in this case Eli Lilly) needs to apply to the TGA to register the medicine in the Australian Register for Therapeutic Goods (ARTG),” she said.
“The TGA will assess the safety, efficacy and quality of the medicine to ensure the benefits outweigh any risks.”