Eli Lilly's first weight-loss pill shows success in initial Phase 3 trials

Lilly CEO says if approved, drug could be manufactured and launched at scale globally

US-based pharmaceutical company Eli Lilly on Thursday announced that its experimental oral GLP-1 pill, named orforglipron, demonstrated statistically significant efficacy results by registering weight loss of nearly 8 per cent at the highest dose.

 

Glucagon-like peptide-1 or GLP-1 is a peptide hormone naturally produced in the body that plays a key role in regulating blood sugar and appetite.

 

Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem.

 

“It is also being studied as a potential treatment for obstructive sleep apnoea and hypertension in adults with obesity,” the company added.

 

The randomised double-placebo trial of the drug measured its efficacy and safety in adults with type 2 diabetes compared to a placebo. After the trial, it was found that the pill lowered A1C, a blood level used to diagnose diabetes, by an average of 1.3 per cent to 1.6 per cent.

 

The trial randomised 559 participants across the United States, China, India, Japan and Mexico in a 1:1:1:1 ratio to receive either 3 milligrams (mg), 12 mg or 36 mg of orforglipron or a placebo.

 

While the company did not specify the demography of the people who took part in the trial, it added that the pill’s safety profile was consistent with injectable GLP-1 medicines in successful Phase 3 trials.

 

Some participants experienced adverse effects, including mild to moderate gastrointestinal issues such as diarrhoea, nausea, indigestion, constipation and vomiting.

 

According to the company, the pill could be an alternative to injections and also the first small molecule oral GLP-1 to succeed in a Phase 3 trial.

 

It added that, if approved, it is confident in its ability to launch orforglipron worldwide without supply constraints.

 

“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,” David A Ricks, Lilly chair and chief executive officer, said.

 

Lilly added that this would further its mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050.

 

The company is a major player in the anti-obesity drugs segment, with medications such as Mounjaro and Zepbound being part of its global weight loss drugs portfolio.