Orforglipron heart safety trial

What happened

On 30 September 2026, Lilly announced detailed results from ACHIEVE-4, a phase 3 trial of orforglipron, which Lilly calls Foundayo in its releases. Lilly’s release says the results were presented at the 62nd annual meeting of the European Association for the Study of Diabetes (EASD) in Milan and published in The Lancet. Here is how Lilly describes the trial:

• Who. 2,749 adults with type 2 diabetes and overweight or obesity who have an increased risk of cardiovascular events, meaning heart and blood-vessel problems.
• Comparison. Orforglipron against insulin glargine, a long-acting insulin, with doses raised in steps in both groups.
• Design. Phase 3, randomized, open-label and event-driven. We explain those terms below.
• Where. Lilly lists 16 countries and territories, including the United States, Brazil, Germany and India. Canada isn’t among them.
• Main goal. To show that the risk of major adverse cardiovascular events (MACE) on orforglipron was non-inferior to the risk on insulin glargine. The main measure, MACE-4, counts cardiovascular death, heart attack, stroke and hospitalization for unstable chest pain. Lilly said the trial met its prespecified criteria for non-inferiority.

Lilly’s release also reports figures for blood sugar, body weight and other measures, and describes side effects seen in the trial. We don’t republish company-reported figures, and we’ve read the release, not the paper in The Lancet. For side effects, read the release or ask your prescriber.

Lilly’s releases describe Foundayo as FDA-approved for adults with obesity, and for some adults with overweight who also have weight-related medical problems. The ACHIEVE-4 release refers to Foundayo as a potential treatment for adults with type 2 diabetes.

On 21 September 2026, Lilly also broke ground on a manufacturing site in Houston, Texas. Lilly says the site, a 6.5 billion US dollar investment, will make the active ingredient for Foundayo. The same release says Foundayo is under regulatory review in more than 40 countries.

What a heart-safety trial tests

A cardiovascular safety trial asks whether a medicine raises the risk of serious heart and blood-vessel problems. Researchers follow people taking the medicine and people on a comparison treatment, count events such as heart attack and stroke, and compare the counts.

ACHIEVE-4 was a non-inferiority trial. It wasn’t built to show that orforglipron does more than insulin glargine. It was built to show that orforglipron isn’t worse by more than a margin the researchers set before the results were in. If the result stays inside that margin, the trial has met its goal. Lilly said ACHIEVE-4 did.

Two other terms from Lilly’s description. Event-driven means the trial runs until enough heart events have been counted to answer the question, so its length depends on how many events happen. Open-label means participants and researchers knew which treatment each person was taking.

A non-inferiority result on heart events is not a Health Canada decision, not a coverage decision, and not advice about whether to take any medicine. Whether a medicine is right for you is a question for your prescriber or pharmacist.

What it means in Canada

Orforglipron isn’t authorized in Canada. Health Canada’s list of new drug submissions under review shows orforglipron calcium from Eli Lilly Canada Inc., accepted in January 2026 as a new active substance, meaning a medicine with an active ingredient that isn’t approved in Canada. A search of Health Canada’s Drug Product Database on 3 October 2026 returned no product containing orforglipron. Foundayo is the name Lilly uses in its releases, and we haven’t confirmed a Canadian brand name. Our note on Health Canada’s list explains what under review means.

The ACHIEVE-4 result is in type 2 diabetes. Health Canada’s list gives orforglipron the class “Drugs used in diabetes”, which is a therapeutic class and doesn’t say which use Lilly asked it to approve. We haven’t confirmed that, so we can’t say whether this trial is part of Canada’s review. The list’s row also says the review is part of an “aligned review” with a health technology assessment organization. We haven’t checked which organization, or whether it has opened a file.

Neither the list nor the Lilly releases we read give a Canadian decision date. Lilly’s 21 September 2026 release says it is targeting a full global rollout in 2027 and doesn’t name Canada. We don’t estimate a Canadian date.

Authorization also wouldn’t settle coverage. Public coverage needs a recommendation from Canada’s Drug Agency (CDA-AMC), a price negotiation through the pan-Canadian Pharmaceutical Alliance (pCPA), and then a listing decision from each province, territory and federal plan. Private insurers run their own evaluations. See coverage across Canada for what we have confirmed by province.

What hasn’t changed

Our drug list shows one GLP-1 tablet: Rybelsus (semaglutide), a daily tablet for type 2 diabetes from Novo Nordisk. We haven’t checked its monograph yet, so we don’t say more about its approved uses. Health Canada’s Drug Product Database lists Rybelsus under Novo Nordisk Canada, and the entry we checked shows a marketed status. The other medicines on our price pages, Ozempic, Wegovy, Mounjaro and Zepbound, are weekly injections.

Nothing in Lilly’s announcement changes what you can get or pay in Canada today. Orforglipron has no pharmacy price on our price pages, because we list prices only for medications already on the Canadian market. A trial result from another country isn’t a reason to start, switch or stop a medicine. Talk to your prescriber or pharmacist about that.

If you want to see how care for medications that are available now differs between services, see our providers page.

What happens next

Health Canada will make a final decision on the submission, or Lilly may cancel it. The entry then moves from the under-review list to the list of completed submissions, and Health Canada says you can check approvals in its Notice of Compliance database. No date has been stated for Canada.

Lilly says it is running ATTAIN-OUTCOMES, an ongoing phase 3 study of heart outcomes in adults with obesity or overweight who have established cardiovascular or kidney disease, with or without type 2 diabetes. We haven’t seen results from it.

If Health Canada authorizes orforglipron, the coverage steps above come next, and each plan’s decision can differ from another’s. We don’t estimate how long they would take. For what’s available today, see our prices and coverage by province.