The global obesity epidemic has spurred pharmaceutical companies to invest heavily in developing effective weight management solutions, leading to a surge in clinical trials for anti-obesity medications.
Amid growing demand for such treatments, significant advancements in drug development are increasingly focused on long-term sustainability and safety to meet the needs of individuals struggling with weight maintenance.
Eli Lilly and Co (NYSE:LLY) on Thursday shared topline results from the ATTAIN-MAINTAIN Phase 3 trial of orforglipron.
The Phase 3 study evaluated orforglipron for weight maintenance over 52 weeks after initial treatment for 72 weeks with the highest tolerated doses of Novo Nordisk A/S‘ (NYSE:NVO) Wegovy (semaglutide) or Zepbound (tirzepatide), in participants from SURMOUNT-5 who were offered the opportunity to be re-randomized to receive orforglipron or placebo.
Data
At one year, orforglipron met the primary and all key secondary endpoints compared to placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity.
Also Read: FDA Weighs Rapid Review For Eli Lilly Obesity Pill As Novo Nordisk Nears Launch
In the study, orforglipron met the primary endpoint of superior percent maintenance of body weight reduction compared to placebo, among SURMOUNT-5 participants who previously reached a body weight plateau.
In pre-specified analyses at 52 weeks, participants who switched to orforglipron from Wegovy maintained their previously achieved weight loss with an average difference of 0.9 kg, while those who switched to orforglipron from Zepbound maintained their previously achieved weight loss with an average difference of 5.0 kg.
In post-hoc analyses at 24 weeks, the change in body weight from ATTAIN-MAINTAIN baseline for patients switching to orforglipron from Wegovy was -0.1 kg vs. 9.4 kg for placebo.
Likewise, for patients switching to orforglipron from Zepbound, the change from baseline was 2.6 kg vs. 9.1 kg for placebo.
The overall safety and tolerability profile of orforglipron was consistent with previous orforglipron Phase 3 studies.
The most common adverse events were gastrointestinal-related and generally mild-to-moderate in severity.
Discontinuation rates due to adverse events for patients randomized to placebo or orforglipron were 4.8% (orforglipron from Wegovy), 7.6% (placebo from Wegovy), 7.2% (orforglipron from Zepbound), and 6.3% (placebo from Zepbound).
No hepatic safety signal was observed.
In the Phase 3 ATTAIN-1 trial, 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 shares were up 2.20% at $1064.73 at the time of publication on Thursday. The stock is approaching its 52-week high of $1111.99, according to Benzinga Pro data.
Read Next:
Photo via Shutterstock
Recent Comments