Eli Lilly and Co ( LLY ) on Wednesday shared topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials of oral orforglipron for reducing blood sugar levels.

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ACHIEVE-2, the second head-to-head trial, evaluated orforglipron versus AstraZeneca Plc’s Farxiga (dapagliflozin) in adults with type 2 diabetes inadequately controlled on commonly used metformin.

Separately, ACHIEVE-5 assessed orforglipron versus placebo in adults with type 2 diabetes and inadequate glycemic control with titrated insulin glargine, with or without metformin and/or SGLT-2 inhibitors.

Data

In both trials, orforglipron (3 mg, 12 mg, 36 mg) met the primary and all key secondary endpoints at 40 weeks for both the efficacy and treatment-regimen estimands, delivering significant A1C reduction (blood sugar) and weight loss as well as improvements in multiple cardiovascular risk factors, all consistent with previously disclosed studies in type 2 diabetes.

In both trials, the overall safety and tolerability profile of orforglipron and the treatment discontinuation rates were consistent with those in previous studies.

The most common adverse events were gastrointestinal-related and generally mild to moderate in severity. No hepatic safety signal was observed.

The detailed results of these trials will be presented at a future medical meeting and published in a peer-reviewed journal.

Results are expected in the first quarter of 2026 for ACHIEVE-4, the final global registration trial in the ACHIEVE program.

What Next?

Lilly plans to submit orforglipron for type 2 diabetes to global regulatory agencies in 2026, while submission for the treatment of obesity is on track to occur by the end of this year.

In September, Eli Lilly ( LLY ) shared detailed results from the Phase 3 ATTAIN-1 trial of orforglipron in adults with obesity, or overweight with a weight-related medical problem, and without diabetes.

At 72 weeks, all three doses (6 mg, 12 mg, and 36 mg) of orforglipron met the primary endpoint of superior body weight reduction compared to placebo.

LLY Price Action: Eli Lilly ( LLY ) shares were up 1.26% at $822.55 at the time of publication on Wednesday, according to Benzinga Pro data.

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