Eli Lilly just can’t seem to stop with the continuous wins in the clinic because just today it announced that it had achieved positive results from its phase 3 ACHIEVE-1 study. This late-stage trial was evaluating the safety and efficacy of its oral small molecule GLP-1 agonist for the treatment of adults with Type 2 Diabetes (T2D) and inadequate glycemic control with diet and exercise alone.

The goal was really to make sure that this drug works in treating patients with Type 2 Diabetes, but despite that, it saw a huge win in terms of being able to generate substantial weight loss for these patients as well. It was noted that patients in the study who were given the highest dose of orforglipron were able to see an average weight loss of 16 lbs. [About 7.9%] weight loss.

Besides being very good news for the company, it established a first in that this drug is the first small-molecule GLP-1 agonist to have successfully finished a phase 3 study for these T2D patients without any type of restrictions in terms of what they could eat or drink. The significance of this released data is that the company now has an oral drug that has achieved an efficacy profile similar to that of injectable GLP-1 agonist drugs like Semaglutide (marketed as OZEMPIC and WEGOVY) from Novo Nordisk.

The fact that significant weight loss was achieved is not to take away from the fact that Orforglipron achieved its main primary endpoint goal of lowering A1C in patients with T2D. It was shown that A1C was reduced by an average amount of between 1.3% to 1.6% across many doses. It is possible for things to get even better with respect to this drug because the scope of it goes beyond that of only treating patients with T2D or obesity.

The company is also evaluating its use in clinical trials for the treatment of patients with obstructive sleep apnea and hypertension. Even the safety profile of its drug was able to get away with being similar to that of injectable GLP-1 drugs. The development of orforglipron goes beyond that of a few studies. As a matter of fact, this ACHIEVE-1 study is the first of seven that are evaluating the use of this drug for the treatment of patients with Type 2 Diabetes and obesity.

Catalysts to expect from Eli Lilly going forward would be that it expects to file a regulatory application for possible approval of orforglipron by the end of this year. This will get the ball rolling for this indication, with global regulatory submissions of this drug for T2D expected to happen in 2026.

The notion of Eli Lilly continuing with wins is because it has already hit the mark, and doing well with its drug ZEPBOUND (tirzepatide). This is a GLP-1/GIP injectable drug approved to treat patients with obesity. The future of weight loss treatments is likely going to be the ability to combine drugs together. Viking Therapeutics is also in the process of developing a dual GLP-1/GIP agonist drug to treat patients with obesity. It is in the process of advancing both an injectable subcutaneous version of this drug and an oral one.