Eli Lilly and Company has reported detailed findings from the ACHIEVE-3 Phase III trial comparing the efficacy and safety of orforglipron and oral semaglutide in adults with type 2 diabetes (T2D) inadequately controlled by metformin.
The trial results, published in The Lancet, show that orforglipron provided greater improvements in both A1C reduction and weight loss.
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The randomised, open-label, 52-week trial enrolled 1,698 patients across China, Argentina, Mexico, Japan, the US, and Puerto Rico.
Participants were assigned to one of four treatment arms: 12mg or 36mg of orforglipron or 7mg or 14mg of oral semaglutide.
The trial aimed to assess whether orforglipron was non-inferior to oral semaglutide in reducing A1C levels after 52 weeks.
All participants receiving orforglipron began with a daily 1mg dose, titrated upwards at four-week intervals to their assigned maintenance dose.
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By GlobalDataSimilarly, those on oral semaglutide started at 3mg daily, increasing stepwise to either 7mg or 14mg. Dose reduction was permitted once for tolerability, with a minimum dose of orforglipron (3mg) or oral semaglutide (7mg).
For the global ACHIEVE Phase III clinical programme of orforglipron, more than 6,000 people with T2D were enrolled across five registration trials. It commenced in 2023, and additional results from the three remaining trials are expected later this year.
Orforglipron also demonstrated improvements in cardiovascular risk factors such as systolic blood pressure, triglycerides, and cholesterol subtypes.
Lilly cardiometabolic health executive vice-president and president Kenneth Custer said: “The results of ACHIEVE-3 highlight the potential advantages of orforglipron over oral semaglutide for type 2 diabetes: greater A1C reduction, more weight loss, and the ability to take it without food or water timing restrictions — that’s a combination that could matter significantly to people managing their disease day in and day out.”
Adverse events were consistent with previous studies; nausea, diarrhoea, vomiting, dyspepsia and decreased appetite were most common.
Discontinuation rates from adverse events ranged from 8.7% to 9.7% for orforglipron and from 4.5% to 4.9% for oral semaglutide.
Lilly has filed orforglipron for regulatory assessment in more than 40 countries, with a submission in the US expected later this year.
Recently, Lilly’s Omvoh (mirikizumab) demonstrated its ability to maintain corticosteroid-free status and support long-term clinical remission in patients with Crohn’s disease.
