Eli Lilly posts detailed late-stage trial data for oral weight loss drug orforglipron

Eli Lilly (NYSE:LLY) on Saturday announced detailed data from its ACHIEVE-1 Phase 3 trial, which reached the main goal for its oral weight loss therapy, orforglipron, in patients with type 2 diabetes early this year.

The GLP-1 receptor agonist hit ACHIEVE-1’s primary endpoint, lowering the diabetes biomarker A1C by 1.3%–1.6% from a baseline of 8.0% across all three doses, the company said, citing a per-protocol analysis.

The 40-week trial for T2D patients suffering from inadequate glycemic control also reached a key secondary endpoint related to obesity, with orforglipron-treated patients attaining an average weight loss of 16.0 lbs (7.9%) at the highest dose of 36 mg.

While ACHIEVE-1 tested once-daily orforglipron at 3 mg, 12 mg, and 36 mg doses, only the latter two dose levels led to clinically meaningful and statistically significant reductions in body weight against placebo.

During the trial, orforglipron’s safety profile was found to be consistent with the established tolerability profile of the GLP-1 class, the Indiana-based drugmaker said, adding that gastrointestinal issues dominated most frequently reported adverse events.

Orforglipron is expected to generate several key late-stage trial readouts over the next few months, with initial data from a Phase 3 trial designed to evaluate it against Novo’s (NVO) oral semaglutide expected later this year.

Meanwhile, the ATTAIN-1 and ATTAIN-2 Phase 3 trials testing orforglipron in weight management are expected to read out in Q3 as the company plans to submit global regulatory filings for the drug in obesity by the end of 2025.