EU panel backs Foundayo amid stomach trade-off

People taking the tablet version of Wegovy start the day by the rules: swallow it on an empty stomach with only a little water, then wait before eating, according to Reuters. Foundayo, a tablet from Eli Lilly for weight management and type 2 diabetes, is taken once a day at any hour, with or without food (EMA). Europe's medicines regulator has now recommended it, which could make this class of drug easier to fit into daily life.

The recommendation came from the agency's scientific committee at its October meeting (CHMP meeting highlights). It is advice, not a licence. The European Commission still has to grant the actual authorisation.

A different key for the same lock

Foundayo belongs to the same family as Wegovy. These drugs mimic GLP-1, a hormone your gut releases after a meal. Picture a lock on the surface of our cells, the receptor for that hormone, and the drug as a key cut to fit it. Turning that key reduces appetite, increases the feeling of fullness and helps control blood sugar (EMA).

The key itself is what's new. Semaglutide, the ingredient in Wegovy, is a peptide, a short chain of amino acids, much like a tiny protein. Orforglipron, the active ingredient in Foundayo, is a small molecule built by chemists, not a peptide. In early studies, researchers gave it without any food or water restrictions (food-effect studies).

What the trials found

The largest weight study, ATTAIN-1, followed 3,127 adults without diabetes for 72 weeks. On the top 36 mg dose they lost 11.2% of their body weight on average, against 2.1% on a placebo, a dummy pill (NEJM). That is a group average, so individual results varied around it. In a companion trial, ATTAIN-2, adults with type 2 diabetes lost 9.6% on the top dose (ATTAIN-2).

For diabetes, doctors track HbA1c, a blood test that shows average sugar levels over the previous few months. Think of it as a running average, not a single snapshot.

The most revealing trial, ACHIEVE-3, pitted orforglipron directly against oral semaglutide in 1,698 adults already taking metformin, the standard first-line diabetes tablet. Orforglipron lowered blood sugar more. At the higher of the two doses tested for each drug, HbA1c fell by 1.91 percentage points with orforglipron versus 1.47 with semaglutide over 52 weeks (ACHIEVE-3). The trial used semaglutide's diabetes doses, so it does not compare Foundayo with the stronger Wegovy obesity pill. It was also open-label, meaning participants knew which drug they were taking, and Lilly funded it.

The cost shows up in the stomach

The proposed use is narrower than a "weight-loss pill" headline suggests. It covers adults with a body-mass index, a measure based on height and weight, of at least 30. People at 27 or above also qualify if they have a weight-related health problem. In both cases the pill comes alongside diet and exercise (Ärzteblatt).

Nausea, vomiting and diarrhoea are the most common side effects. They show up mostly while the dose is being raised and become less frequent over time (EMA). Still, in ATTAIN-1, between 5.3% and 10.3% of people on orforglipron quit because of side effects, against 2.7% on placebo (NEJM).

The head-to-head diabetes trial made that trade-off sharper. Stomach complaints affected about 58% to 59% of orforglipron users, compared with 37% to 45% of those on semaglutide's diabetes doses (ACHIEVE-3).

These trials measured weight and blood sugar, not heart attacks or strokes. A separate study, ATTAIN-Outcomes, is registered to look at cardiovascular events (trial registry).

Once the Commission decides, each member state will set its own price and reimbursement terms (EMA). In trials, Foundayo delivered meaningful weight loss and better blood-sugar control in a pill you can take with your morning coffee and toast. Its demonstrated cost is more stomach trouble, most clearly against semaglutide at diabetes doses. National pricing and reimbursement decisions will shape how many Europeans get to weigh that trade for themselves.