Brigham and Women’s Hospital’s Dr. Caroline Apovian on the broader potential clinical impact of tirzepatide and other weight loss drugs.

Cardiology Pharmaceuticals

Tirzepatide Delivers in SURMOUNT-2

Results from Eli Lilly’s SURMOUNT-2 trial are in, and they further confirmed that its GLP-1 agonist tirzepatide (aka Mounjaro) drives meaningful weight loss among obese or overweight adults with type 2 diabetes. That could be a big deal for the booming obesity care segment, obesity-related cardiovascular disease, and for Eli Lilly.

The trial had 938 adults take 10mg or 15mg of tirzepatide or a placebo over 72 weeks, finding that the GLP-1 groups…

• Achieved far greater average weight loss (13.4% & 15.7% vs. 3.3% of body weight)
• Had far more participants lose at least 5% of body weight (81.6% & 86.4% vs. 30.5%)
• Had far more participants lose at least 15% of body weight (41.4% & 51.8% vs. 2.6%)

Tirzepatide met all key secondary objectives, which included reduction in A1C and other cardiometabolic parameters, matching its previous trials. The GLP-1 also achieved a similar safety profile as its previous trials, most commonly reporting GI-related events.

Tirzepatide/Mounjaro already has FDA approval for diabetes, and it now has two global phase 3 clinical trials supporting its potential for weight loss, following even stronger SURMOUNT-1 results among non-diabetic patients (up to 22% weight loss).

These trial results and Mounjaro’s track record among diabetes patients sets Lilly up for a promising weight loss FDA submission in the next few weeks, with an approval potentially coming by the end of 2023.

That approval would pour gas on the already white hot obesity treatment market, which saw semaglutide (Novo Nordisk’s Ozempic/Wegovy) generate over $10B in 2022. That’s a huge number, but the future might be even more promising for Lilly. Tirzepatide outperformed semaglutide in each of its trials, prompting some pharma watchers to predict that Lilly’s new GLP-1 will bring-in $50B annually.

Tirzepatide could also have an even greater cardiovascular impact in the future (beyond the benefits of weight loss and diabetes control), as the GLP-1 is being evaluated in a range of clinical trials targeting MACE, CKD, and HFpEF.

The Takeaway

Questions remain about the long-term effectiveness and safety of GLP-1s, and payor coverage for these meds has been a challenge, but tirzepatide’s trial results and the huge momentum in the weight loss space suggest that obesity care is about to change in a major way. It wouldn’t be surprising if the way clinicians and patients approach obesity-related cardiovascular care might change along with it.

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The Wire

• Changing Temps Drive Rising CVD Deaths: We can add cardiovascular disease to the list of problems created by climate change after a University Hospitals-led study found that “non-optimal temperatures” (both high and low) were responsible for almost 1.2M million CVD deaths and nearly 22M lost disability-adjusted life years globally in 2019. CVD deaths related to non-optimal temperature rose by 45% between 1990 and 2019, making temperature the ninth greatest CVD death risk factor.

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• CardieX’s Clearance: CardieX announced the FDA 510(k) clearance of its CONNEQT Pulse arterial health monitor, which is reportedly the only vital signs monitor intended for home, clinician, and clinical trial use that measures both brachial and central blood pressure (in addition to other vascular health biomarkers). The CardieX Pulse will be specifically marketed for use in decentralized clinical trials, remote patient monitoring, and self-monitoring, with its CONNEQT Patient Management Portal (CPMP) likely playing a key role when used for RPM and trials.

• Statin Loading Before CABG: The StaRT-CABG trial, a randomized, double-blind study, found that statin loading before coronary artery bypass grafting (CABG) did not provide additional clinical benefits compared to a placebo. Among 2,635 adult patients already on long-term statin treatment, statin loading 12 and 24 hours before CABG, while safe, did not reduce the rate of major adverse cardiac and cerebrovascular events within 30 days after surgery.

• HeartBeam Adds $25M: Remote heart attack detection company HeartBeam raised $25M through a secondary offering of 16.7M shares to fund its 3D-vector electrocardiogram (VECG) platform’s upcoming FDA clearances, support its clinical trials, and fund pre-commercial activities. HeartBeam also extended its commercialization timeline to 2024, while using 2023 to focus on gaining FDA clearances for its “credit card-sized” AIMIGo VECG device and demonstrating its equivalence to standard recorded 12-lead ECGs. The share offering comes two months after HeartBeam acquired AFib detection company LIVMOR.

• Young Women and MI Rehospitalizations: A new study in JACC (2,979 patients, 18-55yrs) found that young women who experience a heart attack are far more likely than young men to be rehospitalized within a year of discharge (34.8% vs. 23%), potentially because younger women who suffer heart attacks have higher CV burdens. Rehospitalizations were most common due to second heart attacks and chest pain, but non-cardiac hospitalizations showed the most significant disparity between men and women (145.8 vs 69.6 per 1k person-years). 

• Dapagliflozin’s Consistent Benefits: A subanalysis of the DELIVER trial revealed that the SGLT2 inhibitor dapagliflozin (AstraZeneca’s Farxiga & Forxiga) reduced the risk of HF events by 23% among 6,263 HFpEF and HFrEF patients (including first and recurrent events). At the study’s 2.3-year median follow-up, the dapagliflozin group (10 mg once daily) experienced 212 fewer worsening HF events and 30 fewer total CV deaths compared with the placebo group. Dapagliflozin’s benefits were consistent across the study’s subgroups, including those with left ventricular ejection fraction.

• DocPanel Adds Cardiac Imaging Expert: Teleradiology practice DocPanel has appointed Scott Flamm, MD, to lead the company’s cardiac imaging department. Flamm comes to DocPanel from the Cleveland Clinic, where he was head of cardiac imaging. He will be available to healthcare facilities through the DocPanel platform for cardiothoracic imaging coverage, protocol assistance, and program development support, while allowing providers to add a new cardiac imaging service to their offerings.

• Black Americans’ Cardiology Deserts: One in three Black Americans, or roughly 16.8M people, live in U.S. counties with little or no access to cardiologists, including over 2M individuals who reside in “cardiology deserts” with no cardiologists at all. That’s from a new GoodRx report, which also found that 70% of the counties with large Black populations in the Southeast U.S. qualified as cardiology deserts, exacerbating the fact that people in those counties generally have higher CVD risk factors. 

• TAVR-explant vs. redo-TAVR: Analysis of the EXPLANTORREDO-TAVR registry (n=396) found that patients with transcatheter heart valve (THV) failure face greater mortality risks with TAVR surgical explantation (TAVR-explant) versus having a second THV implanted (redo-TAVR). TAVR-explant patients had greater mortality rates while still in the hospital (11.6% vs. 2.8%), at 30-days (13.6% vs. 3.4%), and at one year (32.4% vs. 15.4%). However, TAVR-explant and redo-TAVR mortality rates were similar beyond 30 days, suggesting that TAVR-explant’s apparent mortality risks might actually be due to patient health differences.

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