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Do Ozempic, Wegovy or Mounjaro protect the heart? What the trials found

Six large trials tested semaglutide and tirzepatide against heart attacks, strokes and heart deaths. Here is what each found per 100 people, what it cost in side effects, what semaglutide did in heart failure, and what India has approved.

GLP Guidebook teamPublished 5 Oct 202615 min read25 sourcesWritten from published sources

Written for India. Reading from the US? US versionComing soon

The short answer

In trials, people with heart disease or type 2 diabetes took semaglutide (Ozempic, Wegovy, Rybelsus) or a dummy medicine. Fewer had a heart attack, stroke or heart death on semaglutide. The gap was about 2 in 100 people over 2 to 4 years. Mounjaro matched an older injection but was not proven better. More people stopped because of side effects.

Key takeaways

  • In SUSTAIN-6, 6.6 in 100 people on Ozempic 0.5 or 1 mg had a heart attack, stroke or heart death over 2 years, against 8.9 on placebo, but serious diabetic eye problems were 3.0 vs 1.8.1
  • In SELECT, Wegovy 2.4 mg cut these events from 8.0 to 6.5 per 100 people over about 3 years, but 17 in 100 stopped it for side effects, against 8.7
  • In SURPASS-CVOT, Mounjaro (up to 15 mg) had 12.1 heart events per 100 against 13.0 on dulaglutide, an older injection, so was not proven better; 13.3 vs 10.2 in 100 stopped for side effects.4,11
  • Each of the five heart-event trials had sites in India, but Asian people were only 8% to 24% of those enrolled, and the registries do not count South Asians separately.1,16
  • India's drug regulator's expert committee backed heart-risk uses for semaglutide injections in July 2025 and for semaglutide tablets in November 2025; we found none for Mounjaro.17,18
Before you go further
  • GLP-1 medicines are prescription-only in India. A government statement on 1 Apr 2026 said only endocrinologists, internal-medicine specialists and cardiologists can prescribe them.20 CDSCO expert-committee minutes attach a similar condition to some approvals (endocrinologist or internal-medicine specialist), but we found no rule covering every brand.21
  • Every number here is a trial average for a group. None of it can tell anyone their own heart risk.
  • The side effects and serious risks are in Guide 5, Side effects and risks.
On this page
  1. What did the heart trials measure?
  2. What did SUSTAIN-6 find for Ozempic?
  3. What did SELECT find for Wegovy in people without diabetes?
  4. What did SOUL find for Rybelsus tablets?
  5. What does FLOW, the kidney trial, add?
  6. What did SURPASS-CVOT find for Mounjaro?
  7. Is there a heart trial of tirzepatide in people without diabetes?
  8. What does the evidence say about semaglutide in heart failure?
  9. Were Indians in these trials?
  10. What is approved for heart risk in India?
  11. Questions people ask
  12. How we researched this
  13. Sources

What did the heart trials measure?

Each trial counted how many people had a heart attack, a stroke or a heart death, on the medicine or on a comparison.6,7,8,10

Doctors call this bundle "major adverse cardiovascular events" (MACE). Each person counts once, at their first event.7 Most trials compared the medicine with a dummy medicine (placebo). The Mounjaro trial compared it with another diabetes injection instead.10

Two ways to say the same result. SELECT's "20% lower risk" is a relative number.5 In absolute numbers, events fell from 8.0 to 6.5 per 100 people.7 That is 1.5 fewer per 100, or about 1 fewer for every 67 people treated for about 3 years.7

Trial and medicineWho was in itHeart events per 100 peopleA harm, per 100 people
SUSTAIN-6: Ozempic 0.5 or 1 mg weekly3,297 adults with type 2 diabetes and high heart risk; about 2 years16.6 vs 8.9 on placebo1Serious diabetic eye problems 3.0 vs 1.81
SELECT: Wegovy 2.4 mg weekly17,604 adults with heart or artery disease, BMI 27 or more, no diabetes; about 3 years76.5 vs 8.0 on placebo7Stopped for side effects 17 vs 87
SOUL: Rybelsus 14 mg tablet daily9,650 adults with type 2 diabetes and heart or kidney disease; about 4 years312.0 vs 13.8 on placebo3Stopped for side effects 15.5 vs 11.63
FLOW: Ozempic 1 mg weekly3,533 adults with type 2 diabetes and kidney disease; about 3.4 years1,912.0 vs 14.4 on placebo1Stopped for stomach side effects 4.5 vs 1.124
SURPASS-CVOT: Mounjaro up to 15 mg weekly13,299 adults with type 2 diabetes and heart or artery disease; about 4 years412.1 vs 13.0 on dulaglutide 1.5 mg; not proven better4Stopped for side effects 13.3 vs 10.211
SURMOUNT-MMO: tirzepatide weekly15,374 adults with BMI 27 or more and no diabetes12No results yet; completion expected October 202712Not reported yet12

"Heart events" means heart attack, stroke or heart death, counted once per person. Figures are from the US labels except where a trial paper or registry is cited. The groups differ, so the rows can't be compared with each other. Checked 5 Oct 2026.

What did SUSTAIN-6 find for Ozempic?

In type 2 diabetes with high heart risk, 6.6 in 100 people on Ozempic had a heart event over 2 years, against 8.9 on placebo.1

The trial gave Ozempic at 0.5 mg or 1 mg once a week, on top of usual care.1 These are the doses sold in India, where Ozempic comes in 0.25, 0.5 and 1 mg.25 Most people (83%) already had heart disease, kidney disease or both.6

Strokes fell most; heart deaths did not. Non-fatal strokes were 1.6 vs 2.7 per 100.1 Non-fatal heart attacks were 2.9 vs 3.9, a gap that could be chance. Heart deaths were 2.7 vs 2.8.1

The trial was built to check safety. Its main test was whether Ozempic was no worse than placebo for the heart.6 The lower rate was a bonus finding, with 254 events in all.1

The harm that came with it was in the eyes. Serious diabetic eye problems (retinopathy complications) hit 3.0 in 100 on Ozempic and 1.8 on placebo.1 Among people who already had diabetic eye disease, it was 8.2 vs 5.2.1 More people also stopped Ozempic because of side effects, mainly stomach ones.6

What did SELECT find for Wegovy in people without diabetes?

In adults with heart disease and excess weight but no diabetes, Wegovy 2.4 mg cut heart events from 8.0 to 6.5 per 100.7

SELECT tested Wegovy, which is semaglutide at 2.4 mg a week. That is a higher dose than any Ozempic sold in India.25 Our post on Wegovy vs Ozempic explains the difference. Everyone was 45 or older with a BMI of 27 or more. Each had a past heart attack, stroke or leg-artery disease.2

2.8 vs 3.8heart attacks per 100 people2
1.8 vs 2.0strokes per 100; could be chance2
2.5 vs 3.0heart deaths per 100; not confirmed2
17 vs 8in 100 stopped for side effects7

Most of the gap came from heart attacks. The drop in strokes alone was small enough to be chance.2 Heart deaths were lower, but the trial's statistics did not confirm that result.2

What changed in the body. After 2 years, people on Wegovy had lost about 8.5 kg more than on placebo.2 Their top blood-pressure number fell 3.3 points more, and their pulse rose about 3 beats a minute more.2 The trial was not designed to say which change, if any, explains the result.

What it cost. About 17 in 100 stopped Wegovy because of side effects, against 8 on placebo.7 Women on Wegovy had more hip and pelvis fractures, 1.0 vs 0.2 in 100. So did people aged 75 and over.2 Kidney stones were 1.2 vs 0.8 in 100.2

Novo Nordisk, which makes Wegovy and Ozempic, paid for SELECT, SUSTAIN-6, SOUL and FLOW.6,7,8,9 Our answer on Ozempic without diabetes covers the weight side.

The risks, in brief
  • Stomach effects. The EU Wegovy label lists nausea, vomiting, diarrhoea and constipation as very common (more than 1 in 10).5
  • Gallstones. Common on the EU Wegovy label (1 in 10 to 1 in 100).5
  • Inflamed pancreas (pancreatitis). Uncommon on the EU Wegovy label (1 in 100 to 1 in 1,000). In SELECT it was 0.2 vs 0.3 in 100.5
  • Eye problems in diabetes. SUSTAIN-6 found more serious diabetic eye complications on Ozempic, 3.0 vs 1.8 in 100.1
  • Low blood sugar. The risk rises when Ozempic is taken with insulin or a sulfonylurea, a type of diabetes tablet.1
  • Thyroid warning. US labels carry a boxed warning based on rodent thyroid tumours. They rule out use after medullary thyroid cancer or with MEN 2.1
All side effects and risks: Guide 5 →
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What did SOUL find for Rybelsus tablets?

In type 2 diabetes with heart or kidney disease, a daily 14 mg semaglutide tablet cut heart events from 13.8 to 12.0 per 100.3

SOUL tested the Rybelsus tablet at its top 14 mg dose against placebo.8,18 Our post on Ozempic tablets explains the tablet forms. Everyone was 50 or older, with heart disease, kidney disease or both.8

Heart attacks drove the result. Non-fatal heart attacks were 4.0 vs 5.2 per 100.3 Strokes were 3.0 vs 3.3 and heart deaths 6.2 vs 6.6, both close.3 Its kidney results and other second targets did not differ clearly from placebo.8

The cost was more stopping. About 15.5 in 100 stopped the tablet because of side effects, against 11.6 on placebo.3 Serious side effects overall were 47.9% vs 50.3%.8

What does FLOW, the kidney trial, add?

In FLOW, people with type 2 diabetes and kidney disease on Ozempic 1 mg had 12.0 heart events per 100, against 14.4 on placebo.1,9

FLOW's main target was kidney damage, and its result there was 18.7 vs 23.2 per 100.1 Heart events were a second target.9 Heart deaths were 7.0 vs 9.6 per 100.1

People with type 2 diabetes and kidney disease are at high risk of heart events, the FLOW authors note.9 Our answer on GLP-1 medicines and the kidneys covers the kidney results.

Side effects. Overall stopping for side effects was close, 13.2 vs 11.9 in 100.24 Stopping for stomach side effects was 4.5 vs 1.1.24

What did SURPASS-CVOT find for Mounjaro?

Mounjaro was not worse than dulaglutide, an older injection shown to lower heart events. It was not proven better either, at 12.1 vs 13.0 per 100.4

It enrolled 13,299 adults with type 2 diabetes and heart or artery disease. They took Mounjaro (up to 15 mg) or dulaglutide 1.5 mg weekly.4 People were followed for a median of about 4 years.4 The 12.1 vs 13.0 figures are from the US label. The trial paper reports 12.2 vs 13.1, after leaving out 134 people who did not meet entry rules.10 Eli Lilly, which makes Mounjaro, paid for it.10

There was no placebo group. So the trial can't say how Mounjaro compares with no medicine. Fatal or non-fatal heart attacks were 4.7 vs 5.4 per 100, a gap the trial did not confirm.4

Side effects. In Lilly's first results, 13.3 in 100 stopped Mounjaro because of side effects, against 10.2 on dulaglutide.11 Stomach side effects were more common on Mounjaro.10

The US Mounjaro label added a heart-risk use in August 2026.4 In June 2026, Europe's medicines agency accepted the heart benefit but said Mounjaro's diabetes use already covers it.23 Our answer on whether Mounjaro is safe with heart disease covers heart rate and blood pressure.

Is there a heart trial of tirzepatide in people without diabetes?

Yes, SURMOUNT-MMO, but it is still running, with 15,374 people enrolled and completion expected in October 2027.12

It compares tirzepatide, the medicine in Mounjaro, with placebo.13 Entrants are 40 or older, with a BMI of 27 or more and no diabetes. Each has heart disease or several heart risk factors.13

Its main count is broader than the other trials. It adds artery-opening procedures, heart failure events and death from any cause.13 On 5 Oct 2026 the registry listed no results, so nobody can yet say whether tirzepatide matches SELECT.12

What does the evidence say about semaglutide in heart failure?

In two 1-year trials in obesity and one type of heart failure, Wegovy 2.4 mg improved symptoms and walking more than placebo did.14,15

The type is called heart failure with preserved ejection fraction (HFpEF). In these trials, the median share of blood pumped out with each beat (ejection fraction) was 57% and 56%.5 In STEP-HFpEF, 529 people without diabetes walked 21.5 metres further in 6 minutes on Wegovy, against 1.2 on placebo.14 A second trial in 616 people with diabetes found similar gains.15

Symptoms, scored out of 100. STEP-HFpEF used a heart failure questionnaire (KCCQ) where higher scores mean fewer symptoms and limits. Scores rose 16.6 points on Wegovy and 8.7 on placebo.14 In the diabetes trial they rose 13.7 vs 6.4.15

The side effects. In STEP-HFpEF, nausea hit 17 in 100 people on Wegovy and 3 on placebo.16 Serious side effects were fewer on Wegovy, 13.3% vs 26.7%.14 The trial had no sites in India.16

These trials measured symptoms, not deaths or hospital stays. The US Wegovy label says its effect on heart failure "has not been established".2 In SELECT, heart failure hospital stays or urgent visits were 1.1 vs 1.4 per 100. That gap could be chance.2 Wegovy was not studied in the most severe heart failure (NYHA class IV). The EU label does not recommend it there.5 Mounjaro's heart failure trial, SUMMIT, is covered in our answer on Mounjaro and heart disease.

Get help now: call 112. Call for tight or squeezing chest pain, chest pain spreading to the arms, neck or jaw, or severe trouble breathing.22 A heart attack can also feel like indigestion or make you feel sick, which are common GLP-1 side effects too.22,5 So chest symptoms on these medicines can't be assumed to be the medicine.

Were Indians in these trials?

Every heart-event trial (SUSTAIN-6, SELECT, SOUL, FLOW, SURPASS-CVOT) had Indian sites, and Asians were 8% to 24% of those enrolled.1,16 South Asians were not counted separately.16

  • SELECT (Wegovy): 1,447 of 17,604 people were Asian, about 8%. The trial had 34 sites in India.16
  • SUSTAIN-6 (Ozempic): 8% Asian, with 21 sites in India.1,16
  • SOUL (Rybelsus): 2,255 of 9,650 were Asian, about 23%, with 41 sites in India.16
  • FLOW (Ozempic 1 mg): 846 of 3,533 were Asian, about 24%, with 17 sites in India.16
  • SURPASS-CVOT (Mounjaro): 1,170 of 13,299 were Asian, about 9%. Only 235 were enrolled in India, under 2%, at 14 sites.16
  • STEP-HFpEF (Wegovy, heart failure): the registry lists no Asian participants among 529, and no sites in India.16

The EU Wegovy label says SELECT's result was not affected by race.5 But with few South Asians, these trials can't show whether Indians get the same benefit. Guide 1, Weight and health explains why India uses lower BMI cut-offs.

What is approved for heart risk in India?

India's drug regulator's expert committee recommended heart-risk uses for semaglutide injections in July 2025 and semaglutide tablets in November 2025. We found none for Mounjaro.17,18

  • 24 Jun 2025 At Wegovy's Indian launch, Novo Nordisk said it was "the only drug in India to have received regulatory approval for reduction in risk of major adverse cardiovascular events, in addition to long-term chronic weight management".19 We could not find the regulator's record behind this company statement.
  • 17 Jul 2025 CDSCO's expert committee backed a heart-risk use for semaglutide injection 0.25, 0.5 and 1 mg (Ozempic's strengths). It applies to adults with type 2 diabetes and heart disease, on condition of a safety study in India.17
  • 6 Nov 2025 The same committee backed a heart-risk use for semaglutide tablets 3, 7 and 14 mg (Rybelsus's strengths). It covers adults with type 2 diabetes at high risk.18

These later recommendations cover heart risk in type 2 diabetes, not weight management.17,18 Committee minutes are recommendations, and we found no public Indian label showing the final wording.17,18 Neither set of minutes mentions tirzepatide.17,18

In the US, the labels for Ozempic, Wegovy, Rybelsus and Mounjaro all now carry a heart-risk use.1,2,3,4 Guide 4, Should I consider a GLP-1?, covers who these medicines may not suit. Guide 6 lists the brands sold in India.

Questions people ask

Does Ozempic protect the heart?

In SUSTAIN-6, people with type 2 diabetes and high heart risk had fewer heart events on Ozempic. It was 6.6 vs 8.9 per 100 over about 2 years. Serious diabetic eye problems were more common, 3.0 vs 1.8 per 100.1

Does "20% lower risk" mean 20 in 100 people are spared?

No. In SELECT, Wegovy 2.4 mg lowered heart events from 8.0 to 6.5 per 100 people over about 3 years. The 20% is the relative drop; the absolute drop was 1.5 per 100.5,7

Does Mounjaro lower heart attack risk?

In SURPASS-CVOT, Mounjaro matched dulaglutide, an older injection, with 12.1 vs 13.0 heart events per 100 over about 4 years. It was not proven better, and there was no placebo group.4

Were these medicines tested instead of usual heart medicines?

No. The trials added them on top of usual care. At the start of SELECT, 90% took cholesterol-lowering medicine and 86% took medicine that stops blood clots forming (antiplatelets).2

Is semaglutide approved for heart failure?

Not as a separate use in the US. The US Wegovy label says its effect on heart failure has not been established. Two 1-year trials found better symptoms and walking distance in obesity-related heart failure.2,14

How we researched this

On 5 October 2026 we read the US labels for Ozempic, Wegovy, Rybelsus and Mounjaro, and the EU Wegovy label. We took each trial's numbers from the label tables where they exist. We read the published summaries of SUSTAIN-6, SELECT, SOUL, FLOW, SURPASS-CVOT and the two heart-failure trials.

We counted Asian participants and Indian sites from the ClinicalTrials.gov records. We read CDSCO committee minutes from July and November 2025, and saved archive copies. The "per 100" and "1 in 67" figures are our arithmetic from the trial numbers.

Before you move on

  • The heart trials found about 2 fewer events per 100 people over 2 to 4 years. That is no guarantee for anyone.
  • SELECT tested Wegovy 2.4 mg, a higher dose than Ozempic in India.
  • In the four semaglutide heart-event trials, more people stopped semaglutide than placebo because of side effects. In FLOW the gap was small.6,7,3,24
  • The tirzepatide trial in people without diabetes has no results until about late 2027.
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Sources

  1. Novo Nordisk. Ozempic (semaglutide) injection, US prescribing information, revised May 2026: sections 1, 4, 5.3, 5.5, 14.2 (SUSTAIN 6, Table 9) and 14.3 (FLOW, Table 10) (US label, not the Indian one). PDF
  2. Novo Nordisk. Wegovy (semaglutide) US prescribing information, revised June 2026: sections 1, 6.1 and 14.1 (SELECT, Tables 6 and 7) (US label). PDF
  3. Novo Nordisk. Rybelsus and Ozempic tablets (oral semaglutide), US prescribing information, revised January 2026: sections 1, 6.1 and 14.4 (SOUL, Table 10) (US label). PDF
  4. Eli Lilly. Mounjaro (tirzepatide) injection, US prescribing information, revised August 2026: section 1, Recent Major Changes, and 14.6 (SURPASS-CVOT, Table 10) (US label). PDF
  5. European Medicines Agency. Wegovy: EU product information (summary of product characteristics), sections 4.4, 4.8 and 5.1 (EU label). PDF
  6. 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;375:1834–44. Funded by Novo Nordisk. DOI · PMID 27633186
  7. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes (SELECT). N Engl J Med. 2023;389:2221–32. Funded by Novo Nordisk. DOI · PMID 37952131
  8. McGuire DK, Marx N, Mulvagh SL, et al. Oral semaglutide and cardiovascular outcomes in high-risk type 2 diabetes (SOUL). N Engl J Med. 2025;392:2001–12. Funded by Novo Nordisk. DOI · PMID 40162642
  9. 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;391:109–21. Funded by Novo Nordisk. DOI · PMID 38785209
  10. 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;393:2409–20. Funded by Eli Lilly. DOI · PMID 41406444
  11. HCPLive (Abigail Brooks). SURPASS-CVOT: Tirzepatide bests dulaglutide for cardiovascular protection. 31 July 2025 (reports Eli Lilly's topline results). Link
  12. ClinicalTrials.gov. SURMOUNT-MMO, NCT05556512: status "active, not recruiting", 15,374 enrolled, primary completion estimated October 2027, no results posted. Record updated 22 September 2026; checked 5 October 2026. Link
  13. Lam CSP, Rodriguez A, Aminian A, et al. Tirzepatide for reduction of morbidity and mortality in adults with obesity: rationale and design of the SURMOUNT-MMO trial. Obesity. 2025;33:1645–56. DOI · PMID 40545827
  14. Kosiborod MN, Abildstrøm SZ, Borlaug BA, et al. Semaglutide in patients with heart failure with preserved ejection fraction and obesity (STEP-HFpEF). N Engl J Med. 2023;389:1069–84. Funded by Novo Nordisk. DOI · PMID 37622681
  15. Kosiborod MN, Petrie MC, Borlaug BA, et al. Semaglutide in patients with obesity-related heart failure and type 2 diabetes (STEP-HFpEF DM). N Engl J Med. 2024;390:1394–407. Funded by Novo Nordisk. DOI · PMID 38587233
  16. ClinicalTrials.gov results records, baseline race and site lists: SELECT · SUSTAIN-6 · SOUL · FLOW · SURPASS-CVOT (region of enrolment) · STEP-HFpEF. Checked 5 October 2026.
  17. CDSCO. Recommendations of the Subject Expert Committee (Endocrinology & Metabolism), meeting of 17 July 2025, item 3 (semaglutide injection, Novo Nordisk India). Committee minutes; the live file is overwritten at each meeting. PDF · archived copy
  18. CDSCO. Recommendations of the Subject Expert Committee (Endocrinology & Metabolism), meeting of 6 November 2025, item 1 (semaglutide tablets, Novo Nordisk India). Committee minutes. PDF · archived copy
  19. ThePrint (Sumi Sukanya Dutta). Wegovy, the global sensation in obesity management, launched in India. 24 June 2025. Link
  20. Press Information Bureau (PIB Research). GLP-1 Drugs: Use, Risks, and Regulation. Government backgrounder, 1 April 2026. PDF
  21. CDSCO. Recommendations of the Subject Expert Committee (Endocrinology & Metabolism), 20–21 April 2023, item 1 (tirzepatide). Committee minutes. PDF · archived copy
  22. NHS. Heart attack. Page last reviewed 31 March 2026 (UK page; the UK emergency number is 999, India's is 112). Link
  23. European Medicines Agency. Outcome of assessment on use of Mounjaro to reduce the risk of serious events affecting the heart and blood circulation. EMA/140483/2026, 26 June 2026. PDF
  24. RxFiles Academic Detailing. FLOW trial summary, September 2025 (reproduces the trial's safety table). PDF
  25. ThePrint (Reuters). Novo Nordisk again cuts Ozempic, Wegovy prices by up to 48% in India as generics flood market. 1 April 2026. Link

Last checked 5 Oct 2026 · Next review due 5 Oct 2027 · Report an error

How this post was made. Written by the GLP Guidebook team from the sources above. It's general information, not medical advice. Talk to a qualified doctor before starting, stopping or changing any medicine. How we write