Eli Lilly Announces Phase 2 Results of Oral GLP-1R Agonist Orforglipron, Demonstrating Up to 15% Weight Loss at 9 Months

On June 23, Eli Lilly announced the latest Phase II data for orforglipron, the first non-peptide oral glucagon-like peptide-1 (GLP-1) receptor agonist. The study is evaluating orforglipron for chronic weight management in patients with obesity or overweight. Orforglipron met the primary and secondary endpoints for efficacy assessment and demonstrated clinically significant weight loss in obese or overweight adults with at least one weight-related comorbidity (excluding type 2 diabetes). The findings were presented as an oral report at the 83rd Scientific Sessions of the American Diabetes Association and simultaneously published in The New England Journal of Medicine.

In the Week 26 primary endpoint analysis, the orforglipron groups (12mg, 24mg, 36mg, or 45mg) demonstrated statistically significant dose-dependent weight loss across all doses, with reductions ranging from 8.6% (19.8 lbs or 9.0 kg) to 12.6% (29.3 lbs or 13.3 kg), compared to 2.0% (4.6 lbs or 2.1 kg) in the placebo group. For participants taking orforglipron, weight loss continued through Week 36, with reductions across all doses ranging from 9.4% (21.6 lbs or 9.8 kg) to 14.7% (34.0 lbs or 15.4 kg), while the placebo group experienced a weight reduction of 2.3% (5.3 lbs or 2.4 kg). The average baseline weight of participants was 240 lbs (109 kg).

Orforglipron's safety is similar to other incretin-based treatments. Gastrointestinal side effects are the most commonly reported adverse events, generally mild to moderate in severity, and typically occur during dose escalation.

• At the 36-week efficacy evaluation, all four evaluated doses of orforglipron met all key secondary endpoints, including:

• Weight loss ≥5%: 72% (12mg), 90% (24mg), 92% (36mg), and 90% (45mg), compared to 24% in the placebo group;

• Weight loss ≥10%: 47% (12mg), 62% (24mg), 75% (36mg), and 69% (45mg), compared to 9% in the placebo group;

• Reduction in BMI from baseline: 0.9 kg/m2 in the placebo group, and 3.4 kg/m2 (12mg), 4.7 kg/m2 (24mg), 5.0 kg/m2 (36mg), and 5.5 kg/m2 (45mg) in the four orforglipron dose groups, respectively;

• Reduction in waist circumference from baseline: 9.6cm (12mg), 11.2cm (24mg), 10.6cm (36mg), 13.6cm (45mg), compared to 4cm in the placebo group.

Eli Lilly and Company has initiated Phase III clinical trials to further investigate the efficacy and safety of orforglipron in treating obesity and overweight (ATTAIN trial) and type 2 diabetes (ACHIEVE trial).

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