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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What are the effects of Mounjaro® (tirzepatide) in patients with type 2 diabetes and heart failure?
In a SURPASS-CVOT analysis, tirzepatide treatment in patients with or without HF resulted in a lower all-cause death and HF events composite, all-cause death, and MACE-4 than dulaglutide. Safety was similar, but GI events were higher with tirzepatide.
See important safety information, including boxed warning, in the attached prescribing information.
TIRZEPATIDE is not approved to reduce the risk of heart failure in adults with type 2 diabetes. Please see prescribing information for approved indication(s).
Content Overview
Tirzepatide Outcomes in Patients with Type 2 Diabetes and Heart Failure from SURPASS-CVOT
SURPASS-CVOT was an event-driven, randomized, double-blind, active comparator, parallel-group phase 3 study assessing the efficacy and safety of tirzepatide, up to 15 mg versus dulaglutide 1.5 mg on MACE-3 when added to standard of care in participants with type 2 diabetes (T2D) with established atherosclerotic cardiovascular disease (ASCVD).1
SURPASS-CVOT is the largest and longest study of tirzepatide to date, with a median follow-up of 4 years.1
A pre-specified analysis investigated outcomes in patients with and without a prior history of HF.2
Back to Content Overview.
Baseline Characteristics by History of Heart Failure
Baseline characteristics are presented in Baseline Characteristics by Treatment Group and History of Heart Failure from SURPASS-CVOT. Of note, more patients with a history of HF (20.3%) than those without HF (79.7%) had a
- history of coronary artery disease (77.6% vs 61.8%), and
- prior myocardial infarction (57.8% vs 44.5%).3
History of Heart Failure |
No History of Heart Failure |
|||
Characteristic/Medication Use/Metabolic Risk Factor |
TZP |
Dula |
TZP |
Dula |
Baseline Characteristics |
||||
Age, mean, years |
64.8 |
64.7 |
63.8 |
64.0 |
Female, % |
28.3 |
29.8 |
28.8 |
29.1 |
White, % |
88.4 |
87.8 |
79.8 |
79.7 |
Prior MI, % |
57.8 |
57.8 |
44.4 |
44.7 |
Prior stroke, % |
20.5 |
19.1 |
18.7 |
19.4 |
Peripheral artery disease, % |
26.8 |
28.5 |
24.8 |
24.6 |
Hypertension, % |
95.2 |
96.0 |
89.0 |
88.7 |
Diabetes duration, mean, years |
14.8 |
14.5 |
14.8 |
14.7 |
Baseline Medication Use |
||||
Statin, % |
88.3 |
85.8 |
85.5 |
85.6 |
Beta-blockers, % |
78.7 |
77.9 |
62.2 |
61.6 |
ACE inhibitor, % |
43.1 |
44.2 |
39.6 |
38.1 |
Angiotensin receptor blocker, % |
41.3 |
40.1 |
39.7 |
41.1 |
Mineralocorticoid receptor antagonist, % |
25.5 |
23.2 |
5.7 |
5.7 |
Loop diuretic, % |
45.5 |
41.2 |
17.0 |
15.8 |
Thiazide diuretic, % |
9.1 |
9.8 |
15.1 |
14.3 |
Metformin, % |
77.4 |
78.7 |
82.0 |
82.5 |
SGLT2 inhibitor, % |
31.1 |
30.1 |
30.2 |
31.0 |
Insulin, % |
51.1 |
48.7 |
49.0 |
48.2 |
Baseline Metabolic Risk Factorsa |
||||
Weight, kg |
95.9 |
96.7 |
91.8 |
91.4 |
BMI, kg/m² |
33.5 |
33.6 |
32.4 |
32.3 |
Systolic BP, mmHg |
134.7 |
135.4 |
134.9 |
135.3 |
Diastolic BP, mmHg |
77.8 |
78.4 |
77.6 |
77.7 |
HbA1c, % |
8.43 |
8.40 |
8.40 |
8.38 |
LDL cholesterol, mg/dL |
84.7 |
87.0 |
79.5 |
79.0 |
Triglycerides, mg/dL |
203.7 |
194.7 |
194.9 |
192.8 |
eGFR, mL/min/1.73 m² |
71.9 |
74.9 |
80.1 |
80.4 |
eGFR <60 mL/min/1.73 m², % |
33.3 |
27.9 |
20.9 |
20.1 |
Abbreviations: ACE = angiotensin-converting enzyme; BMI = body mass index; BP = blood pressure; Dula = dulaglutide; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; LDL= low-density lipoprotein; MI = myocardial infarction; SGLT2 = sodium-glucose co-transporter 2; TZP = tirzepatide
aData represented as mean unless otherwise specified.
Back to Content Overview.
Efficacy Outcomes
Compared to dulaglutide, treatment with tirzepatide in patients with and without a prior history of HF resulted in a lower proportion of patients with
- all-cause death and HF events, and
- all-cause death (Efficacy Outcomes of Tirzepatide vs Dulaglutide in Patients With and Without a History of Heart Failure).3
Additionally, tirzepatide had greater changes in glycated hemoglobin (HbA1c), body weight, blood pressure, and estimated glomerular filtration rate (eGFR) compared with dulaglutide in patients with and without a prior history of HF (Efficacy Outcomes of Tirzepatide vs Dulaglutide in Patients With and Without a History of Heart Failure).3
Endpoint |
History of Heart Failure |
No History of Heart Failure |
||||
TZP |
Dula |
HR (95% CI)a |
TZP |
Dula |
HR (95% CI)a |
|
All-cause death or hospitalization/urgent visits for HF |
18.2% |
21.5% |
0.83 (0.70-0.99)b |
8.6% |
9.7% |
0.88 (0.78-1.00)b |
All-cause death |
13.5% |
16.7% |
0.80 (0.65-0.97)b |
7.4% |
8.4% |
0.86 (0.75-0.99)b |
Hospitalization or urgent visits for HF |
7.6% |
7.7% |
0.97 (0.73-1.27) |
1.9% |
1.9% |
0.98 (0.74-1.30) |
MACE-3c |
17.2% |
18.7% |
0.90 (0.76-1.08) |
10.9% |
11.6% |
0.93 (0.83-1.04) |
MACE-4d |
20.5% |
24.7% |
0.81 (0.69-0.95) |
15.5% |
16.9% |
0.91 (0.83-1.00) |
CV death |
8.9% |
11.0% |
0.80 (0.63-1.02) |
4.7% |
4.9% |
0.95 (0.80-1.13) |
Myocardial infarction |
6.0% |
5.9% |
0.99 (0.73,1.36) |
4.4% |
5.3% |
0.83 (0.75, 0.99) |
Stroke |
4.4% |
4.8% |
0.89 (0.62, 1.27) |
3.3% |
3.5% |
0.92 (0.75, 1.14) |
Coronary revascularization |
7.9% |
10.1% |
0.76 (0.59, 0.98) |
8.0% |
9.2% |
0.87 (0.76, 0.99) |
Mean changes in metabolic parameters (baseline to month 36) |
||||||
HbA1c (%) |
-1.60 |
-0.90 |
|
-1.68 |
-0.87 |
|
Body weight (%) |
-11.2 |
-5.1 |
|
-11.7 |
-4.7 |
|
Systolic blood pressure (%) |
-6.0 |
-3.9 |
|
-6.2 |
-4.2 |
|
eGFR (mL/min/1.73m²) |
-7.1 |
-8.0 |
|
-7.2 |
-8.1 |
|
Changes in patient reported outcomes (baseline to month 48) |
||||||
APPADL score |
+1.5 |
-2.8 |
|
+2.0 |
-2.1 |
|
EQ-5D-5L VAS score |
+3.2 |
+0.7 |
|
+2.7 |
+0.4 |
|
Abbreviations: APPADL = Ability to Perform Physical Activities of Daily Living; CV = cardiovascular; Dula = dulaglutide; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; HF = heart failure; MACE = major adverse cardiovascular event; TZP = tirzepatide; VAS = visual analog scale.
aHazard Ratio and Confidence Intervals are derived from a Cox proportional-hazards model with treatment (Tirzepatide Maximum Tolerated Dose versus Dulaglutide 1.5 mg) as a fixed effect, stratified by SGLT2 inhibitor use at baseline.
bp ≤ .05
cMACE-3 includes death due to CV or undetermined cause, myocardial infarction, or stroke.
dMACE-4 includes MACE-3 components with the addition of coronary revascularization.
Back to Content Overview.
Safety Outcomes
Safety outcomes were similar in the tirzepatide and dulaglutide groups, however, an increase in GI adverse events was observed with tirzepatide in patients with and without a prior history of HF.3
Adverse Event, % |
Heart Failure |
No Heart Failure |
||
TZP MTD |
Dula 1.5 mg |
TZP MTD |
Dula 1.5 mg |
|
Any TEAE |
90.7 |
90.4 |
89.3 |
88.2 |
Participants with ≥1 SAE |
35.1 |
37.6 |
31.0 |
30.4 |
AEs leading to study drug discontinuation |
20.9 |
19.9 |
18.2 |
15.9 |
TEAEs occurring in ≥1% of participants |
||||
Nausea |
23.9 |
21.5 |
25.4 |
22.6 |
Diarrhea |
24.5 |
17.2 |
24.9 |
19.6 |
COVID-19 |
14.0 |
15.2 |
17.0 |
16.5 |
Decreased appetite |
19.2 |
9.2 |
16.6 |
9.9 |
Constipation |
11.4 |
9.3 |
13.0 |
12.2 |
Vomiting |
10.6 |
7.5 |
11.9 |
10.2 |
Dyspepsia |
9.9 |
7.3 |
10.0 |
8.4 |
Urinary tract infection |
7.8 |
6.7 |
7.0 |
7.6 |
Dizziness |
7.1 |
7.0 |
7.0 |
6.0 |
Arthralgia |
5.1 |
5.8 |
6.4 |
6.5 |
Cataract |
6.0 |
6.4 |
5.7 |
6.1 |
Back pain |
4.8 |
4.3 |
6.0 |
6.2 |
Nasopharyngitis |
6.9 |
6.1 |
5.4 |
5.5 |
Hypertension |
4.2 |
4.7 |
5.1 |
6.2 |
Abbreviations: AEs = adverse events; COVID-19 = coronavirus disease-19; Dula = dulaglutide; MTD = maximum tolerated dose; SAE = serious adverse event; TEAE = treatment-emergent adverse event; TZP = tirzepatide
Back to Content Overview.
Use in Patients with Type 2 Diabetes and Congestive Heart Failure Class IV
There is no information on the use of tirzepatide in patients with a history of class IV congestive heart failure. In the SURPASS clinical program of tirzepatide for type 2 diabetes, participants were excluded if they had a history of class IV congestive heart failure.4,5
Back to Content Overview.
Enclosed Prescribing Information
Reference
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Nicholls SJ, Bhatt DL, Buse JB, et al. Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Am Heart J. 2024;267:1-11. https://doi.org/10.1016/j.ahj.2023.09.007
2Nicholls SJ, Pavo I, Nishiyama H, D'Alessio D. Once-weekly tirzepatide versus dulaglutide for heart failure outcomes in patients with type 2 diabetes, ASCVD, and history of heart failure (pre-specified analysis of the SURPASS-CVOT randomized clinical trial. Abstract. 98th American Heart Association Congress; November 7-10, 2025; New Orleans, LA.
3Nicholls SJ. Once-weekly tirzepatide versus dulaglutide for heart failure outcomes in patients with type 2 diabetes, ASCVD, and history of heart failure: an analysis of SURPASS-CVOT. Presented at: 98th American Heart Association Congress; November 7-10, 2025; New Orleans, LA.
4Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6
5Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519
Date of Last Review: October 30, 2025