All three doses of orforglipron superior to placebo with respect to primary end point of change in HbA1c from baseline to week 40
By Elana Gotkine HealthDay Reporter
WEDNESDAY, June 25, 2025 (HealthDay News) — The oral small-molecule glucagon-like peptide-1 receptor agonist, orforglipron, reduced glycated hemoglobin (HbA1c) over 40 weeks in adults with early type 2 diabetes, according to a study published online June 21 in the New England Journal of Medicine to coincide with the annual meeting of the American Diabetes Association, held from June 20 to 23 in Chicago.
Julio Rosenstock, M.D., from the Velocity Clinical Research Center at Medical City Dallas, and colleagues conducted a phase 3 trial involving participants with type 2 diabetes treated only with diet and exercise, an HbA1c level of ≥7.0 to ≤9.5 percent, and a body mass index of at least 23.0 kg/m2. Five hundred fifty-nine participants were randomly assigned to receive orforglipron (3 mg, 12 mg, or 36 mg) or placebo once daily for 40 weeks.
The researchers found that the estimated mean change from baseline in the HbA1c was −1.24, −1.47, −1.48, and −0.41 percentage points at week 40 with the 3-mg, 12-mg, and 36-mg doses and with placebo, respectively. With respect to this primary end point, all three doses of orforglipron were superior to placebo. At week 40, the mean Hb1Ac levels were 6.5 to 6.7 percent with orforglipron. From baseline to week 40, the percent change in body weight was −4.5, −5.8, and −7.6 percent with the 3-mg, 12-mg, and 36-mg doses, respectively, and −1.7 percent with placebo. Mild-to-moderate gastrointestinal events were the most common adverse events with orforglipron.
“Significant and clinically meaningful reductions in the glycated hemoglobin level were observed with all three doses of orforglipron, and the changes were significantly greater than those with placebo,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Eli Lilly, which is developing orforglipron and funded the study.
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