Eli Lilly, a multinational pharmaceutical company, just passed a major milestone: their new oral GLP-1 medication, orforglipron, has successfully completed its third phase three trial. This means that Eli Lilly now has the clinical data it needs to initiate global regulatory filings for orforglipron, taking us one step closer to having another FDA-approved oral GLP-1 option.

What is orforglipron?

Orforglipron is an investigational, once-daily, oral GLP-1 agonist developed by Eli Lilly. It’s designed to help manage blood sugar and support weight loss, and can be taken at any time of day, with no restrictions on food and water intake.

Orfloglipron has the potential to be as effective as injectable GLP-1s like semaglutide and tirzepatide. If approved, it would provide a convenient oral option for weight-loss treatment, making obesity and diabetes treatment even more accessible to individuals all around the world.

About the ATTAIN-2 trial

The phase 3 ATTAIN-2 trial compared the efficacy and safety of orforglipron at 6 mg, 12 mg, and 36 mg doses for adults with obesity and type 2 diabetes.

Other key study insights:

• The phase 3 trial lasted 72 weeks and was double-blind, randomized, and placebo-controlled
• Included 1,600 participants from multiple countries

Findings of the phase 3 trials

Participants taking the highest dose of orforglipron lost an average of 23 pounds (10.5% of their body weight) after 72 weeks. Among those taking the highest dose, 75% achieved an A1C level at or below 6.5%, which is lower than the American Diabetes Association’s definition of diabetes.

The trial showed clinically meaningful benefits across other areas as well:

• Lower LDL cholesterol
• Improved blood pressure
• Improved triglyceride levels
• Reduced inflammation

As for safety and side effects, the overall safety profile for orforglipron was consistent with established GLP-1 agonists like Ozempic®. The most common side effects were gastrointestinal-related and were reported as mild to moderate in severity.

What this means for patients

A pill that works as well as injectables like Ozempic® and Zepbound® could be a game-changer for patients and health systems. For starters, many prefer pills over needles, and the convenience is a huge factor as well (i.e., no refrigeration, no extra equipment, easy to carry around, etc.). 

With strong data in hand, Eli Lilly plans to submit for global approval this year for orforglipron to be used for weight management, with type 2 diabetes submission following in 2026. Investor confidence is high as well, suggesting that there will be fewer financial hurdles to jump over if the product is approved for mass production. 

All in all, the future is looking bright for oral GLP-1s and all who hope to use them. 

Another option for GLP-1 users

Orforglipron could be a breakthrough in treatment for weight loss and diabetes, offering the efficacy of injectable GLP-1s without the hassle of needles. With rapid progress across multiple phase 3 trials, it is positioned as a promising new option. While FDA approval isn’t guaranteed at this point, passing multiple phase 3 trials is an important step to getting there.

Keep an eye on Shed’s blog for the latest on GLP-1 news, including Eli Lilly’s orforglipron, in the coming months.

FAQs about the Eli Lilly trials

What are the benefits of oral GLP-1s?

The main benefits of oral GLP-1s include removing barriers like injections, needle anxiety, and cold storage. This would make treatment available to more people worldwide. The Eli Lilly ATTAIN-2 trial also showed that the safety and benefits of orforglipron were comparable to injectable GLP-1 drugs, including weight loss and blood sugar regulation.

What are the side effects of orforglipron?

According to the trial results, side effects for orforglipron are similar to those seen in injectable GLP-1 medications like Ozempic®. These include gastrointestinal issues like nausea, vomiting, diarrhea, and constipation, which were reported to be mild to moderate in severity.

When will orforglipron be approved?

Eli Lilly plans to submit regulatory applications for obesity in 2025 and for diabetes in 2026, aiming for global rollout after that. Approval timelines vary widely and depend on a variety of factors, so it’s too soon to say exactly when orforglipron will be FDA-approved. That being said, submitting for regulatory approval is an important step in the right direction.