As Amgen strives to become the industry’s top player in cardiometabolic risk reduction by the start of the next decade, the company took to the American Diabetes Association 2026 Scientific Sessions in New Orleans this past weekend with multiple goals in mind.
For one, the company showed up with data intended to bolster the evidence behind its cholesterol-lowering blockbuster Repatha in a high-risk patient subgroup, while executives also sought to make the case for Amgen’s obesity and diabetes pipeline asset MariTide against the field of existing hormone receptor agonist drugs.
Headlining the California drugmaker’s showing at ADA this year were new data from the company’s phase 3 Vesalius-CV study, specifically subgroup findings among roughly 6,000 patients with high-risk diabetes and elevated LDL-C—otherwise known as “bad” cholesterol—without a prior heart attack or stroke.
In the subgroup results, patients who received Repatha on top of statins or other LDL-C-lowering therapies had a 29% lower risk of coronary heart disease death, myocardial infarction or ischemic stroke compared with placebo.
Moreover, Repatha reduced the risk of a second composite primary endpoint that included ischemia-driven revascularization by 21%.
Looking at the study, the “result is clear,” Paul Burton, M.D., Ph.D., chief medical officer at Amgen, told Fierce in an interview ahead of the company’s ADA Scientific Sessions presentation.
“[E]arlier intensive lipid-lowering therapy with Repatha in these patients with high-risk diabetes, but without a cardiovascular event, profoundly protects them,” he explained.
Those results were further augmented by a separate Amgen presentation on its Vesalius-Real global study, which enrolled 350,000 patients across 11 different countries with the same characteristics covered above.
Those results help highlight “the big problem,” according to Burton, “which is that the vast majority of patients who need LDL-C lowering are either untreated or undertreated, and without that intensified lipid-lowering therapy, they’re not going to get the kind of protection that we’re able to show with Repatha in Vesalius CV.”
Amgen has submitted the “full data package” from Vesalius-CV to regulators in the U.S. and abroad, and the company is expecting an approval in the diabetes population “soon,” per Burton.
Repatha won its original approval more than a decade ago to treat a genetic disorder that causes dangerously high LDL-C, but since then it has scored approvals to reduce cardio risks in a range of patients, including those without a prior diagnosis of cardiovascular disease.
“For all intents and purposes, Repatha can be used in these patients,” Burton said in reference to the high-risk diabetes patient subgroup presented on at ADA. Nevertheless, the company hopes to secure a formal inclusion of the high-risk diabetes population in Repatha’s label, the CMO noted.
MariTide’s voyage continues
While Amgen did not present new data on its antibody-peptide conjugate MariTide (maridebart cafraglutide) during ADA this past weekend, the company remains “really excited about where we are” with the obesity and Type 2 diabetes asset, Susan Sweeney, EVP of obesity and related conditions at Amgen, said in an interview with Fierce on the sidelines of the 2026 Scientific Sessions.
With adherence issues among leading GLP-1 drugs like semaglutide and tirzepatide well documented, MariTide offers “a completely different approach,” both with regards to efforts by Amgen to improve tolerability, and because the drug is being designed for much less frequent dosing than the current crop of weekly GLP-1 injectables or daily oral options, Sweeney argued.
Amgen is testing the drug at monthly dosing intervals and even less frequent administration, which could see patients take the medication every two months or even every quarter, representing what could be a major convenience edge over currently approved therapeutics in the field.
And as previously disclosed, Amgen is attempting to quell the gastrointestinal side effects reported in its midstage test of MariTide by utilizing a three-step dose escalation process over a span of eight weeks, Sweeney explained.
Amgen’s phase 3 Maritime program is looking at the effects MariTide over 72 weeks both in patients with obesity who don’t have Type 2 diabetes and those who do, as well as comorbidities like cardiovascular disease, heart failure and sleep apnea, and in patients with Type 2 diabetes alone. That expansive program points to increasing efforts among drug developers to address metabolic health holistically with their chronic weight management assets.
As for how MariTide might fit into the current diabetes and obesity landscape, “we think we have a very unique offering for patients in the market that not only need to start therapy, but they need to stay on therapy,” Sweeney said, tying that potential to the appeal of MariTide’s less frequent dosing.
The issue of adherence was put front and center in several other Amgen abstracts presented over the weekend, which looked at persistence and adherence to GLP-1-based treatments in U.S. type 2 diabetes patients, as well as the impact of GLP-1 discontinuation on weight loss and glycemic goals in the same population, among others.
In the persistence and adherence analysis, which looked at 28 studies including 267,542 patients, Amgen found that 69% of Type 2 diabetes patients were persistent on their GLP-1 at 6 months, while that figure dropped to 49% over the span of an entire year.
“I think if you distill it down, what it says to you is that the currently available GLP-1 therapies do not drive strong compliance, adherence and perseverance from patients, and that at least half of them have discontinued their therapy within one year,” Burton explained.
Moreover, “that failure to persevere with therapy translates into loss of diabetes control,” Burton added.
He continued, “You don’t see the kind of HbA1c reduction that you see in clinical trials, or we’ve seen in Maritime,” referencing Amgen’s phase 3 program for MariTide, “and you don’t see the kind of weight loss control that we see in clinical trials, so there’s a big unmet need here.”
With Repatha, MariTide and the company’s investigational siRNA drug olpasiran, Amgen’s ambition “is to be the global leader in the management of cardiometabolic risk by 2030,” Burton added.
“We think we have really important medicines that can address that unmet medical need, and it’s why we feel so confident that we can realize that ambition by 2030," he said.