Insulin Glargine(Boehringer Ingelheim)

If everything goes to plan, Eli Lilly will file for approval of orforglipron in Type 2 diabetes in 2026.\n Eli Lilly has guided its oral GLP-1 drug candidate orforglipron through two more late-phase tests in Type 2 diabetes, racking up wins against placebo and AstraZeneca’s Farxiga to stay on track to seek approval in the indication next year.Lilly has run two sets of phase 3 trials for orforglipron, one to support approval in obesity and another to unlock the diabetes market. The company previously posted diabetes victories over placebo and oral semaglutide, Novo Nordisk’s GLP-1 drug. Wednesday, Lilly shared data from two of the remaining three trials in its diabetes program.One trial compared three doses (3 mg, 12 mg and 36 mg) of orforglipron to dapagliflozin, an SGLT-2 inhibitor that AstraZeneca sells as Farxiga. The trial enrolled adults with Type 2 diabetes inadequately controlled on metformin. At Week 40, patients\' A1C, a measure of blood glucose, fell up to 1.7% on orforglipron and 0.8% on dapagliflozin.The other trial compared the same three doses of orforglipron to placebo in adults with Type 2 diabetes and inadequate glycemic control with titrated insulin glargine. After 40 weeks of treatment, Lilly saw A1C reductions of up to 2.1% in the orforglipron arms, versus a 0.8% decline in the placebo cohort.The A1C reductions were big enough for both trials to hit their primary endpoints. Lilly said the studies also met all key secondary endpoints at 40 weeks. Patients taking orforglipron lost weight and showed improvements in multiple cardiovascular risk factors, although Lilly is yet to share the data for these endpoints. Similarly, Lilly said the safety and tolerability profile was consistent with prior studies without sharing any numbers. Lilly’s A1C data raise questions about the need for the high dose. A1C decreased 1.7% in patients taking 12 mg and 36 mg of orforglipron in the dapagliflozin comparison study. Lilly saw a larger drop in A1C on the middle, 12-mg dose than the top dose in the placebo-controlled trial. A1C fell 2.1% on the middle dose, compared to 1.9% on the top dose. Lilly plans to share more data at a future medical meeting.  The topline readout means Lilly\'s drug has now delivered wins in four of the five trials in its phase 3 diabetes program. Data from the final global registration trial are due in the first quarter of next year. If everything goes to plan, Lilly will file for approval of orforglipron in Type 2 diabetes in 2026, adding to an obesity submission that is scheduled for this year.Obesity has dominated the thoughts of investors, who sent Lilly’s share price down when weight loss data fell short of expectations earlier this year. But the company sees diabetes as a big opportunity too. Patrik Jonsson, president of Lilly International, told attendees at a Wells Fargo event last month that “the oral Type 2 market in the U.S. is huge” and orforglipron could be a really good medicine in the indication.   

Eli Lilly’s GLP-1 pill has succeeded in two more late-stage trials in type 2 diabetes. The company said Wednesday that orforglipron beat AstraZeneca’s Farxiga at lowering patients’ blood sugar levels in one trial, and it topped placebo on the same measure in a different study in patients who were also taking insulin. The data bolster the case for the pill’s approval in diabetes that could come next year. In the trial designated ACHIEVE-2, the highest dose of Lilly’s drug cut A1C, a measure of glucose in a patient’s blood, by 1.6% after 40 weeks of treatment. Patients given Farxiga had an A1C reduction of 0.8%. Farxiga is an oral SGLT2 inhibitor approved to treat heart failure, but also to help type 2 diabetes patients control their blood glucose levels. Subjects in ACHIEVE-2 couldn’t maintain glycemic control despite taking metformin, the generic diabetes medication. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. The study tested three doses of orforglipron — 3 mg, 12 mg and 36 mg, each taken once per day. All doses of orforglipron hit statistical significance versus AstraZeneca’s drug on the A1C measure. Lilly said that the trial hit “all key secondary endpoints” too, showing “significant” weight loss as well as improvements in certain cardiovascular risk factors. It did not detail the data for the secondary endpoints. In the other study, named ACHIEVE-5, the same three doses of orforglipron were given alongside Lilly’s long-acting insulin Basaglar. The combo reduced blood sugar levels by 1.8% in patients who received the highest dose at 40 weeks. Patients given a placebo on top of Basaglar saw their blood sugar fall by 0.8%. Again, the difference was significant at all doses. The trial’s participants were permitted to take metformin and/or SGLT2 inhibitors as background therapy. Lilly’s pill already demonstrated a benefit in its first Phase 3 test in type 2 diabetes patients in April . Additional data backing this use arrived last month, when orforglipron beat Novo Nordisk’s rival GLP-1 pill Rybelsus in a head-to-head battle. The drug was roughly as safe and tolerable as it has been in prior trials, Lilly said. The new data come as a relief to the company after the pill disappointed in one obesity study earlier this year. In fairness, the product performed better in patients with both obesity and diabetes than in patients with obesity alone. There is one last study in the ACHIEVE suite of diabetes trials still left to read out. ACHIEVE-4 is testing the pill head-to-head against Basaglar, seeing if it can reduce the risk of cardiovascular events, including heart attacks, strokes and death. Data could come in the first half of next year. Lilly plans to seek approval of orforglipron for type 2 diabetes in 2026. First, though, it plans to submit an application for the drug’s use in obesity, with that filing coming this year. The drugmaker is also trialing the pill in obstructive sleep apnea, high blood pressure and osteoarthritis pain in adults with obesity.