While Truist Securities analysts said the results from the ATTAIN-2 trial leave “room for competition,” they also pointed to a manufacturing advantage that could unlock a “double-digit billion dollar opportunity” for Eli Lilly.
Eli Lilly’s obesity pill orforglipron cut body weight by more than 10% in patients with type II diabetes who also have overweight or obesity, giving the pharma enough data to move forward with an FDA application.
Findings from the Phase III ATTAIN-2 study, published Tuesday, showed that patients treated with 36-mg orforglipron for 72 weeks—including possible dose interruptions or modifications—lowered their weight by 10.5%—or 22.9 lbs. Placebo counterparts saw 2.2% (5.1 lbs) weight loss over the same time span.
In an analysis that included all patients, regardless of adherence and dropouts, orforglipron elicited a 9.6% drop in weight at 36 mgs versus 2.5% in placebo.
Shares of Eli Lilly are up 3% in pre-market trading Tuesday. With data from both ATTAIN-2 and the related ATTAIN-1 trial in hand, Lilly plans to file for approval of orforglipron, with a submission to the FDA planned this year, according to the company’s news release.
Writing to investors on Tuesday morning, analysts at Truist Securities said ATTAIN-2’s findings are “in-line” with market expectations, though they leave “room for competition.” One crucial factor in orforglipron’s favor, the analysts added, is “ease of manufacturing,” which could unlock a “double-digit billion dollar opportunity” for Lilly. Other analysts, including BMO Capital Markets, have previously noted that orforglipron could enjoy a manufacturing advantage as a small molecule.
Truist currently anticipates $14.7 billion in peak worldwide sales for orforglipron.
Aside from weight loss, orforglipron treatment also improved glucose control in diabetes. Blood A1C levels dropped by 1.8% in patients given the highest dose, 36 mgs, compared to 0.1% for patients receiving placebo. As for safety, ATTAIN-2 found orforglipron to be in line with the broader GLP-1 class, with no new signals of concern. As with other GLP-1 therapies, gastrointestinal side effects were common, including nausea, vomiting, constipation and diarrhea. Treatment discontinuations due to toxicities reached as high as 10.9% in the orforglipron arms.
Lilly expects to share more detailed findings from ATTAIN-2 at an upcoming medical congress.
Tuesday’s readout comes just weeks after Lilly released data from the Phase III ATTAIN-1 study, which focused on patients with overweight or obesity and related medical problems, but not diabetes. In that study, orforglipron cut body weight by 12.4% at the same dose level and over the same duration of follow-up. Weight loss in the placebo group was 0.9%.
During its second-quarter earnings call earlier this month, Lilly executives expressed optimism about the ATTAIN-1 data. Chief Scientific Officer Dan Skovronsky said at the time that the results are “as good as it gets” for a GLP-1 therapy, not to mention one taken orally as opposed to subcutaneously.
Investors and analysts weren’t as enthusiastic, however, as orforglipron’s efficacy in ATTAIN-1 paled in comparison to the 13.7% weight loss generated by injectable semaglutide in the Phase III SURMOUNT-5 trial.
