Lilly’s oral diabetes pill shows potential for blood sugar control and weight loss in global trial

American pharmaceutical company Eli Lilly and Company this week announced results from a late-stage clinical trial for its oral diabetes medicine, orforglipron. The once-daily pill, currently under investigation, is being studied for adults with type 2 diabetes who are not on any anti-diabetic medication and have been managing their condition through diet and exercise alone.

In addition to its effect on lowering blood sugar, the pill has shown potential in supporting weight loss, offering a new treatment option for people with both diabetes and obesity.

According to the company, the pill met its primary target in the 40-week Phase 3 study, known as ACHIEVE-1, by lowering average blood sugar (HbA1c) levels compared to placebo. “ACHIEVE-1 is the first of seven Phase 3 studies examining the safety and efficacy of orforglipron across people with diabetes and obesity. Our latest incretin medicine meets our expectations for safety and tolerability, glucose control, and weight loss, and we look forward to additional data readouts later this year,” said David A. Ricks, Lilly chair and CEO.

Orforglipron is the first oral small molecule GLP-1 receptor agonist to complete a Phase 3 trial. GLP-1 drugs are typically given by injection and are widely used for managing blood sugar and supporting weight loss in people with diabetes and obesity.

Lilly said that participants taking orforglipron achieved an average reduction in HbA1c of 1.3% to 1.6%, compared to just 0.1% in the placebo group. More than 65% of participants on the highest dose reached an HbA1c level of 6.5% or below – the threshold for diabetes control as defined by the American Diabetes Association.

In addition to improved blood sugar levels, the pill also led to weight loss. At the highest dose, participants lost an average of 16.0 pounds, or 7.3 kg – equating to 7.9% of their body weight. The company noted that weight loss had not plateaued by the time the trial ended, stating: “Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained.”

The company said the pill can be taken without any food or water restrictions. “Orforglipron can be taken any time of the day without restrictions on food and water intake,” it noted. This may make it easier for patients to stay on treatment compared to injectable alternatives. Lilly added that, if approved, it expects to make the medicine widely available: “As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world,” said Ricks.

The study involved 559 participants from five countries – the United States, China, India, Japan, and Mexico – and compared three doses of orforglipron (3 mg, 12 mg, and 36 mg) with a placebo. Participants began at a lower dose and increased gradually over several weeks to their assigned maintenance dose. All participants had a starting HbA1c between 7.0% and 9.5% and a body mass index (BMI) of 23 kg/m² or higher.

The safety profile of the pill was described as consistent with existing injectable GLP-1 medicines. The most common side effects were gastrointestinal in nature and mostly mild to moderate. “The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity,” the company said. These included diarrhoea (reported by up to 26% of patients), nausea (up to 18%), indigestion, constipation, and vomiting. “No hepatic safety signal was observed,” the company added.

The percentage of participants who discontinued treatment due to side effects ranged from 4% to 8%, depending on the dose, compared to 1% in the placebo group.

Lilly plans to present these findings at the American Diabetes Association’s 85th Scientific Sessions and also publish the results in a peer-reviewed journal. “The ACHIEVE-1 results will be presented at ADA's 85th Scientific Sessions and published in a peer-reviewed journal,” the company said. It expects to submit the drug for regulatory approval for weight management by the end of 2025, with a separate application for type 2 diabetes in 2026. Additional results from the ACHIEVE and ATTAIN trials are expected later this year.

Orforglipron was originally discovered by Chugai Pharmaceutical Co., Ltd. and licensed to Lilly in 2018. It is also being studied for conditions linked to obesity, including sleep apnoea and high blood pressure.
If approved, orforglipron could provide a non-injectable alternative for people with type 2 diabetes. With diabetes projected to affect 760 million adults globally by 2050, Lilly stated: “We are confident in our ability to launch orforglipron worldwide without supply constraints.”

Lilly launched Mounjaro (tirzepatide) in India in March 2025, following approval by the Central Drugs Standard Control Organisation (CDSCO). Priced between ₹14,000 and ₹17,500 per month, it is available in 2.5 mg and 5 mg doses and offers dual treatment for both diabetes and obesity. Mounjaro combines GLP-1 and GIP receptor agonists, offering a novel approach to managing these two chronic conditions. The launch comes as India faces rising rates of diabetes and obesity, creating a significant demand for effective, non-injection-based treatments. 

With over 1.4 billion people, India is home to 77 million individuals living with diabetes. The nation’s growing middle class and lifestyle changes have increased the demand for diabetes management solutions. In this landscape, pharmaceutical companies are introducing treatments, and the market for GLP-1 receptor agonists, which address both blood sugar and obesity, is seeing significant growth.

Danish drug maker Novo Nordisk also plans to launch Wegovy, its blockbuster weight loss drug based on semaglutide, in the coming months of 2025. Indian pharmaceutical companies like Cipla, Sun Pharma, and Zydus Cadila are also expanding their diabetes and obesity offerings, further intensifying competition.