Eli Lilly’s Foundayo (orforglipron), the only oral GLP-1 weight loss treatment that can be taken at any time of the day with no food or water restrictions, has been approved by the US FDA for adults with obesity, or who are overweight with weight-related medical problems.
The GLP-1 weight loss pill helps individuals lose weight when used alongside a reduced-calorie diet and increased physical activity.
Foudayo is taken once daily, at any time of the day, and has no restriction on food or water intake.
The US FDA approval was supported by results from the ATTAIN clinical trial programme, with participants in the ATTAIN-1 trials losing an average of 27.3lb (12.4%) with the highest does of Foundayo, compared to 2.2lb (0.9%) with placebo.
Regardless of trial completion, participants taking the pill lost an average of 25lb, compared to 5.3lb with placebo.
Markers such as cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure also saw reductions during treatment with Foundayo in the ATTAIN programme.
David Ricks, chair and CEO of Eli Lilly and Company, said: “Today, fewer than one in ten 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 Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications.”
Alongside its use for chronic weight management, Lilly is also studying Foundayo as a treatment for type 2 diabetes, obstructive sleep apnoea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.
Joe Nadglowski, president and CEO of the Obesity Action Coalition, said: “New treatment options expand choice and help more people find care that fits their lives, their goals and where they are in their journey – whether they’re just starting to explore treatment or looking for a different long-term approach.”
Foundayo has been submitted for approval in over 40 countries as a weight management tool and/or a type 2 diabetes treatment.