Reference

Which GLP-1 medicines carry a cardiovascular or kidney indication — and exactly who each one covers

By the US Health Digest editorial team · Published September 4, 2026 · Every claim linked to its primary source

Six of the eight current US GLP-1 labels we read on DailyMed on September 4, 2026 carry a cardiovascular indication in Section 1, and exactly one of them — Wegovy — covers adults who do not have type 2 diabetes. One carries a kidney indication: Ozempic injection. Mounjaro’s label caught up with its August 28 approval in SPL version 40, effective August 27, 2026. Zepbound and Saxenda carry neither.

This page reports what current FDA labelling and published trials say. It does not recommend any medicine, and it is not advice to start, stop or change treatment.

An indication belongs to an application, not to a molecule

The single most common error in coverage of this subject is to attach a cardiovascular indication to a drug substance. The FDA approves labelling for an application, so two products containing the identical molecule can carry different Section 1 text. Tirzepatide is sold as Mounjaro and as Zepbound; liraglutide as Victoza and as Saxenda. In each pair the diabetes product carries a cardiovascular indication and the weight-management product does not.

Saxenda makes the point sharply. Its label does discuss LEADER, the liraglutide cardiovascular outcomes trial — but in Adverse Reactions, as safety data, where it states that “No increased risk for MACE was observed with liraglutide 1.8 mg” and adds that “Liraglutide 1.8 mg (Victoza) is used in the treatment of type 2 diabetes mellitus in adults.” The evidence sits on the label. The indication does not.

What follows was built by reading Section 1, Indications and Usage, of eight current Structured Product Labels on DailyMed on September 4, 2026, recording each document’s setid, SPL version number, publication date and document effective date. We did not build it from manufacturer press releases, which routinely run ahead of the label a pharmacist actually pulls up.

Every cardiovascular and kidney indication on a current US GLP-1 label

The two-document rule on oral semaglutide

Oral semaglutide is the one product here where a reader could reasonably end up at two different documents, because DailyMed now carries a combined label titled “OZEMPIC (ORAL SEMAGLUTIDE) TABLET RYBELSUS (ORAL SEMAGLUTIDE) TABLET”. We queried DailyMed’s index for every current SPL naming semaglutide on September 4, 2026: it returns nine documents, and exactly one covers the tablets — setid 27f15fac-7d98-4114-a2ec-92494a91da98. There is no separate current Rybelsus-only label. That setid’s version history runs back to version 1, published September 24, 2019, which is the original Rybelsus document, retitled at version 14 to name both brands. That is the document we used. The injectable Ozempic is a genuinely different application with its own setid and, as the table shows, a narrower cardiovascular population. Our companion piece on the GLP-1 pills covers how the oral products differ in other respects.

With diabetes, without diabetes, or both: the line almost everyone gets wrong

Of the six products with a cardiovascular indication, five name type 2 diabetes in the indication itself. One does not. Wegovy’s first indication reads, in full: “to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.” Diabetes is absent from that sentence in both directions — it is not required, and it is not excluded.

The trial behind it drew a harder line than the label does. Section 14.1 of the same document describes SELECT and states that “Patients with a history of type 1 or type 2 diabetes were excluded.” So the studied population was adults with established cardiovascular disease and overweight or obesity without diabetes, while the labelled population is adults with established cardiovascular disease and overweight or obesity, full stop. A label is broader than its trial here, deliberately. Both of the sloppy summaries you will read elsewhere — “Wegovy’s heart indication is only for people without diabetes” and “GLP-1s are approved to cut heart risk in anyone with obesity” — are wrong, in opposite directions.

The five diabetes indications are not interchangeable either. Victoza and injectable Ozempic require “established cardiovascular disease.” Mounjaro and the oral semaglutide tablets use a different phrase, “at high risk for these events,” which is not a synonym. Trulicity reaches furthest: “established cardiovascular disease or multiple cardiovascular risk factors,” the only one of the six whose wording puts risk factors alone on the same footing as established disease. That tracks REWIND, which enrolled adults aged 50 or older with either a previous cardiovascular event or cardiovascular risk factors.

The kidney indication is narrower still, and there is only one of it. Injectable Ozempic is indicated “to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.” Nobody without type 2 diabetes is covered by any kidney indication on any of these labels.

The trials, their analyses and their intervals

One methodological caution before the numbers, because it is where cross-trial comparison usually breaks. All seven of these figures come from time-to-first-event analyses of the primary composite in each trial’s randomised population, as reported in the primary publication’s abstract — with one exception we should name: SURPASS-CVOT reports its primary endpoint in a modified intention-to-treat population of 13,165, after 134 of the 13,299 randomised patients were excluded for not meeting inclusion criteria. None of those abstracts uses the word “estimand” or labels its analysis treatment-policy, treatment-regimen or efficacy; we have not read the protocols or statistical analysis plans, so we describe each analysis as its publication describes it rather than assigning it a label it does not claim. What that does mean is that these are like-for-like in analysis type — and emphatically not like-for-like in population, comparator or era.

Placebo-controlled, no diabetes: SELECT

SELECT (NCT03574597) was an event-driven superiority trial in 17,604 adults aged 45 or older with preexisting cardiovascular disease, a BMI of 27 or greater, and no history of diabetes. A primary event occurred in 569 of 8,803 (6.5%) on semaglutide 2.4 mg and 701 of 8,801 (8.0%) on placebo: hazard ratio 0.80, 95% CI 0.72 to 0.90, P<0.001, over a mean follow-up of 39.8 months. Adverse events leading to permanent discontinuation occurred in 16.6% on semaglutide and 8.2% on placebo.

Placebo-controlled, kidney endpoint: FLOW

FLOW (NCT03819153) randomised 3,533 adults with type 2 diabetes and chronic kidney disease to semaglutide 1.0 mg or placebo and was stopped early on a recommendation at a prespecified interim analysis, after a median 3.4 years. The primary outcome was a composite of kidney failure, a 50% or greater fall in eGFR, or death from kidney-related or cardiovascular causes: 331 versus 410 first events, hazard ratio 0.76, 95% CI 0.66 to 0.88, P = 0.0003. Death from cardiovascular causes was 0.71 (95% CI 0.56 to 0.89) and death from any cause 0.80 (95% CI 0.67 to 0.95).

Placebo-controlled, type 2 diabetes: SUSTAIN 6, SOUL, LEADER, REWIND

SUSTAIN 6 (PMID 27633186) tested injectable semaglutide against placebo in 3,297 adults for 104 weeks with a non-inferiority margin of 1.8: 6.6% versus 8.9%, hazard ratio 0.74, 95% CI 0.58 to 0.95. SOUL (NCT03914326) tested oral semaglutide against placebo in 9,650 adults with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease or both: 12.0% versus 13.8%, hazard ratio 0.86, 95% CI 0.77 to 0.96, P = 0.006, over a median 49.5 months — and its confirmatory secondary outcomes, including the kidney composite, “did not differ significantly between the two groups.” LEADER (NCT01179048) randomised 9,340 adults with type 2 diabetes at high cardiovascular risk to liraglutide or placebo: 13.0% versus 14.9%, hazard ratio 0.87, 95% CI 0.78 to 0.97, P<0.001 for non-inferiority and P = 0.01 for superiority, median follow-up 3.8 years. REWIND (NCT01394952) randomised 9,901 adults aged 50 or older — 4,589 of them, or 46.3%, women — with a previous cardiovascular event or cardiovascular risk factors, and reported the primary outcome in 594 (12.0%) on dulaglutide and 663 (13.4%) on placebo: hazard ratio 0.88, 95% CI 0.79 to 0.99, p = 0.026, over a median 5.4 years, in the intention-to-treat population.

Active-controlled: SURPASS-CVOT

SURPASS-CVOT (NCT04255433) is the outlier, and the reason it is drawn with a different marker above. It randomised 13,299 adults with type 2 diabetes and established cardiovascular disease to tirzepatide or dulaglutide 1.5 mg — not placebo. A first MACE-3 event occurred in 12.2% on tirzepatide and 13.1% on dulaglutide: hazard ratio 0.92, 95.3% CI 0.83 to 1.01. Non-inferiority was met against a margin of 1.05; superiority was not established, and the interval crosses 1. Mounjaro’s Section 14.6 now reproduces those figures on the label itself. Our full read of that trial, including the exploratory imputed-placebo analysis its investigators published separately, is in what SURPASS-CVOT showed and what it did not.

Mounjaro’s label has now caught up — an update to what we published two days ago

On September 2, 2026 we reported that the FDA’s August 28 approval had not yet reached Mounjaro’s published label: the current document on DailyMed was then SPL version 38, effective April 22, 2026, and its Section 1 named glycemic control only. That gap has closed. As of September 4, 2026 the current document is SPL version 40, published September 2, 2026, document effective August 27, 2026, printed “Revised: 8/2026”. Its Section 1 now carries the cardiovascular indication verbatim, and a new Section 14.6, “Cardiovascular Outcomes Trial of MOUNJARO in Adults with Type 2 Diabetes Mellitus and Established Cardiovascular Disease,” describes SURPASS-CVOT in full. Anything you read that still says the Mounjaro label lacks the indication — including the version of that statement we ourselves published two days ago — is now out of date.

Zepbound was revised on the same cycle and did not change in this respect. Its current document is SPL version 40, published September 2, 2026, effective August 28, 2026 — a day later than the Mounjaro revision — and its Section 1 still lists weight management and obstructive sleep apnea only.

What none of these eight labels carries

Three absences are worth stating precisely, because each is a claim about something not existing and those are the easiest claims to get wrong.

• No heart-failure indication. None of the eight labels above names heart failure in Section 1 — the string “heart failure” occurs zero times in the Indications and Usage section of every one of them. We tested this two ways on September 4, 2026: by extracting and counting over Section 1 of all eight Structured Product Labels, and by searching the open web for a semaglutide or tirzepatide heart-failure approval, which returned trial coverage of STEP-HFpEF and SUMMIT and no approval.
• Zepbound has no cardiovascular indication, and no trial result to support one yet. SURMOUNT-MMO is the trial that would answer the question for people taking tirzepatide for weight rather than diabetes. Its ClinicalTrials.gov record, retrieved September 4, 2026, shows actual enrolment of 15,374, status active and not recruiting, estimated primary completion October 2027, and hasResults: false. A PubMed search the same day for “SURMOUNT-MMO” returned eight records and a search for the registry number NCT05556512 returned one; none is a results publication — the closest are a rationale-and-design paper and a commentary, both in Obesity in September 2025. We cover that trial separately: SURMOUNT-MMO.
• No kidney indication exists outside type 2 diabetes. The only kidney indication among these eight is injectable Ozempic’s, and its own wording restricts it to adults with type 2 diabetes and chronic kidney disease.

Why a cardiovascular indication matters beyond the heart

An on-label cardiovascular indication is frequently the thing that makes a claim payable, because US coverage rules are written around indications rather than molecules. The clearest example is statutory: Medicare is barred from covering drugs used for weight loss. When Wegovy received its cardiovascular indication on March 8, 2024, that changed — not because the drug changed, but because it acquired a medically accepted indication that is not the excluded one. KFF’s April 24, 2024 analysis put it plainly: “Medicare is currently prohibited by law from covering Wegovy and other medications when used specifically for obesity,” and the new indication opened the door. KFF estimated from 2020 data that 3.6 million Medicare beneficiaries — just over 1 in 4 of the 13.7 million diagnosed with obesity or overweight — had established cardiovascular disease plus obesity or overweight and could therefore be eligible.

Three practical consequences follow, and none of them is a promise that a given plan will pay.

1. Which indication your prescription is written under can decide the claim, even when the drug is identical. That is the whole substance of the Mounjaro-versus-Zepbound and Victoza-versus-Saxenda distinction above.
2. The population wording is the eligibility test. “Established cardiovascular disease” and “multiple cardiovascular risk factors” are different criteria, and a utilisation-management rule can be built on either.
3. A denial is a document, and documents can be answered. Our step-by-step guide to appealing a GLP-1 coverage denial sets out internal appeal, external review and Part D deadlines; our 2026 coverage guide covers the Medicare GLP-1 Bridge, state Medicaid variation and what employer plans actually do.

Questions for your prescriber

• Which brand am I actually being prescribed, and which numbered indication on that brand’s current label applies to me?
• Do I meet the population named in that indication — established cardiovascular disease, multiple risk factors, or chronic kidney disease with type 2 diabetes?
• If reducing cardiovascular risk is the goal, which product has outcome data in a population that resembles mine, and was the comparator placebo or another active drug?
• If I do not have type 2 diabetes, does any kidney-outcome evidence apply to me at all?
• Has the label for my product been revised since I was prescribed it, and does Section 1 still say what it said then?

Frequently asked questions

How many GLP-1 medicines carry an FDA cardiovascular indication?

Six of the eight current US labels we read on DailyMed on September 4, 2026: Wegovy in both its injection and tablet forms, injectable Ozempic, the shared Rybelsus and Ozempic tablets label, Mounjaro, Victoza and Trulicity. Zepbound and Saxenda carry none. The count rose from five to six when Mounjaro's Structured Product Label was revised to version 40, published September 2, 2026, picking up the indication the FDA had approved on August 28. This is a count of the eight products we read, not a census of every GLP-1-containing product sold in the United States.

Which GLP-1 cardiovascular indication covers people who do not have diabetes?

Only Wegovy's. Its Section 1 covers adults with established CV disease and either obesity or overweight, and the sentence does not mention diabetes at all, so it neither requires nor excludes it. The other five cardiovascular indications all name type 2 diabetes explicitly. SELECT, the trial behind Wegovy's indication, went further than the label does and excluded anyone with a history of type 1 or type 2 diabetes, so the labelled population is broader than the studied one.

Does any GLP-1 carry a kidney indication?

One does. Injectable Ozempic is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. The evidence is FLOW, which randomised 3,533 adults with type 2 diabetes and chronic kidney disease to semaglutide 1.0 mg or placebo, was stopped early at a prespecified interim analysis, and reported a hazard ratio of 0.76 with a 95 percent confidence interval of 0.66 to 0.88 for its primary kidney composite. No kidney indication exists outside type 2 diabetes on any of these labels.

Does Mounjaro's label carry the cardiovascular indication yet?

Yes, as of September 4, 2026. The current document on DailyMed is SPL version 40, published September 2, 2026, document effective August 27, 2026, printed Revised 8/2026. Its Section 1 now includes reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who are at high risk for these events, and a new Section 14.6 describes SURPASS-CVOT. Earlier reporting, including our own on September 2, described version 38 as lacking the indication; that was accurate then and is out of date now.

Why does Zepbound not have a cardiovascular indication if it is the same molecule as Mounjaro?

Because an indication attaches to the labelling of an approved application, not to a drug substance. Mounjaro and Zepbound are both tirzepatide, sold by Eli Lilly under two separate applications with two separate labels. The cardiovascular evidence, SURPASS-CVOT, was generated in adults with type 2 diabetes and established cardiovascular disease, which is Mounjaro's population. The equivalent trial in a weight-management population, SURMOUNT-MMO, is active and not recruiting with an estimated primary completion of October 2027 and no posted results. The same pattern holds for liraglutide, where Victoza carries a cardiovascular indication and Saxenda does not.

Sources

1. DailyMed. WEGOVY (semaglutide) injection and tablets. National Library of Medicine; SPL version 19, published June 30, 2026; document effective June 18, 2026. Sections 1 and 14.1.
2. DailyMed. OZEMPIC (semaglutide) injection. SPL version 20, published June 10, 2026; effective June 1, 2026. Sections 1, 14.2 and 14.3.
3. DailyMed. RYBELSUS and OZEMPIC (oral semaglutide) tablets. SPL version 14, published August 19, 2026; effective January 30, 2026. Sections 1 and 14.4. Version history retrieved to version 1, published September 24, 2019.
4. DailyMed. MOUNJARO (tirzepatide) injection. SPL version 40, published September 2, 2026; effective August 27, 2026. Sections 1 and 14.6.
5. DailyMed. ZEPBOUND (tirzepatide) injection. SPL version 40, published September 2, 2026; effective August 28, 2026. Sections 1 and 14.
6. DailyMed. VICTOZA (liraglutide) injection. SPL version 31, published November 17, 2025; effective October 14, 2025. Sections 1 and 14.3.
7. DailyMed. SAXENDA (liraglutide) injection. SPL version 22, published June 15, 2026; effective February 25, 2026. Section 1 and the Cardiovascular Safety passage in Adverse Reactions.
8. DailyMed. TRULICITY (dulaglutide) injection. SPL version 62, published August 10, 2026; effective June 16, 2026. Sections 1 and 14.5.
9. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). N Engl J Med. 2023;389(24):2221–2232. PMID 37952131. NCT03574597.
10. Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW). N Engl J Med. 2024;391(2):109–121. PMID 38785209. NCT03819153.
11. McGuire DK, et al. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes (SOUL). N Engl J Med. 2025. PMID 40162642. NCT03914326.
12. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (LEADER). N Engl J Med. 2016;375(4):311–322. PMID 27295427. NCT01179048.
13. Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN 6). N Engl J Med. 2016;375(19):1834–1844. PMID 27633186. NCT01720446.
14. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND). Lancet. 2019;394(10193):121–130. PMID 31189511. NCT01394952.
15. Nicholls SJ, Pavo I, Bhatt DL, et al. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (SURPASS-CVOT). N Engl J Med. 2025;393(24):2409–2420. PMID 41406444. NCT04255433.
16. Eli Lilly and Company. FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk. News release, August 28, 2026. Cited for the approval date only.
17. ClinicalTrials.gov. SURMOUNT-MMO (NCT05556512). Actual enrolment 15,374; active, not recruiting; estimated primary completion October 2027; no posted results. Retrieved September 4, 2026.
18. US Food and Drug Administration. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. March 8, 2024.
19. KFF. A New Use for Wegovy Opens the Door to Medicare Coverage for Millions of People with Obesity. April 24, 2024.
20. KFF. An Estimated 1 in 4 Medicare Beneficiaries With Obesity or Overweight Could Be Eligible for Medicare Coverage of Wegovy. April 24, 2024. Analysis of 2020 data.