Eli Lilly’s weight loss pill won FDA approval on Wednesday 1 April.
The glucagon-like peptide-1 (GLP-1) receptor agonist, orforglipron, was approved for use in combination with a reduced-calorie diet and increased physical activity, facilitating long-term weight loss in adults with obesity or those with overweight and at least one weight-related comorbid condition.
Lilly has reportedly submitted orforglipron for approval for weight management, Type 2 diabetes or a combination of the two in more than 40 countries and has plans to launch shortly.
Prescriptions will be accepted immediately and shipping will begin on 6 April, the company said.
Orforglipron use
Orforglipron is a once-daily oral medication with a starting dosage of 0.8 mg that should not be used in combination with another GLP-1.
David A. Ricks, Chair and CEO, Eli Lilly and Company, said: “Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn’t serious enough for treatment.
“We believe [orforglipron] can help level the playing field for those living with obesity or who are overweight and living with weight-related complications.
“As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”
The ATTAIN trials
Two randomised, double-blind trials saw adults with obesity or overweight with one or more weight-related medical conditions take orforglipron for 72 weeks, in combination with a reduced-calorie diet and increased physical activity.
In the ATTAIN-1 trial, people who continually took the highest dose of orforglipron lost an average of more than 12% of their body weight, compared with around 1% in the placebo cohort.
Participants taking the drug, regardless of trial completion, lost an average of more than 10% of their body weight, compared to approximately 2% with placebo.
Orforglipron also led to reductions in cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.
Dr Deborah Horn, Director of the Center for Obesity Medicine, McGovern Medical School, UTHealth Houston, said: “People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment.
“With [orforglipron], we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day.”
Featured image: Tada Images on Adobe Stock
