Reset Your Expectations with Mounjaro1*
Every dose of Mounjaro is superior to Ozempic® (semaglutide) 1 mg in reducing A1C1*
The primary endpoint was mean change in A1C from baseline at 40 weeks.
IN ADULT PATIENTS WITH TYPE 2 DIABETES (T2D) ON METFORMIN
REDUCTIONS IN A1C FROM BASELINE (%)1
Bar chart depicting A1C change from baseline at 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and each treatment group had a mean baseline A1C of 8.3%. Mean change in A1C at 40 weeks was - 2.0% (p<0.05 for superiority vs. Ozempic, adjusted for multiplicity), -2.2% (p<0.001 for superiority vs. Ozempic, adjusted for multiplicity), -2.3% (p<0.001 for superiority vs. Ozempic, adjusted for multiplicity), and -1.9% for Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg, respectively
Patients reached up to 2.3% A1C reduction with Mounjaro 15 mg1*
*In other studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in A1C with Mounjaro ranged from 1.8% to 2.1% for the 5-mg dose, 1.7% to 2.4% for the 10-mg dose, and 1.7% to 2.4% for the 15-mg dose.1
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Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Mounjaro.
Discover the weight reduction results reported in a clinical trial
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
EXPLORE THE DATASustained A1C reductions at every dose1*
The primary endpoint was mean change in A1C from baseline at 40 weeks.
IN ADULT PATIENTS WITH T2D ON METFORMIN
MEAN A1C OVER TIME FROM BASELINE TO WEEK 401
Line graph depicting mean A1C over time to 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and each treatment group had a mean baseline A1C of 8.3%. The observed mean A1C at 40 weeks was 6.2%, 6.0%, 5.9%, and 6.4% for Mounjaro 5 mg (n=451), 10 mg (n=445), 15 mg (n=447), and Ozempic 1 mg (n=443), respectively. The least-squares mean A1C at 40 weeks with multiple imputation was 6.3%, 6.0%, 6.0%, and 6.4% for Mounjaro 5 mg (n=470), 10 mg (n=469), 15 mg (n=469), and Ozempic 1 mg (n=468), respectively.
Mean A1C reductions were observed starting at week 4 and continued through week 401
*In other studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in A1C with Mounjaro ranged from 1.8% to 2.1% for the 5-mg dose, 1.7% to 2.4% for the 10-mg dose, and 1.7% to 2.4% for the 15-mg dose.1
Data represent observed means from week 0 to week 40, and least-squares mean at week 40 MI. mITT population, full analysis set. ANCOVA analysis was performed for change from baseline at week 40 and MMRM analysis was performed for change over time.
ANCOVA=analysis of covariance; MI=multiple imputation; mITT=modified intent-to-treat; MMRM=mixed model for repeated measures.
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Risk of Thyroid C-cell Tumors: Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
†The ADA states that an A1C target of <7% (53 mmol/mol) is appropriate for many nonpregnant adults without significant hypoglycemia.1,2
‡Key secondary endpoint controlled for type I error. Logistic regression adjusted for baseline value and other stratification factors.
§Proportion of participants with A1C ≤6.5% was evaluated as an additional secondary endpoint not controlled for type I error. Logistic regression adjusted for baseline value and other stratification factors, with multiple imputation using retrieved dropout for missing value at 40 weeks.
ADA=American Diabetes Association.
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Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has been reported in Mounjaro clinical trials. Mounjaro has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on Mounjaro. Observe patients for signs and symptoms including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Mounjaro and initiate appropriate management.
Common adverse reactions in placebo-controlled trials1
Adverse reactions in pool of placebo-controlled trials reported in ≥5% of Mounjaro-treated patients1
| MOUNJARO 5 mg (n=237) % | MOUNJARO 10 mg (n=240) % | MOUNJARO 15 mg (n=241) % | PLACEBO (n=235) % | |
|---|---|---|---|---|
| Nausea | MOUNJARO 5 mg (n=237): 12% | MOUNJARO 10 mg (n=240): 15% | MOUNJARO 15 mg (n=241): 18% | PLACEBO (n=235): 4% |
| Diarrhea | MOUNJARO 5 mg (n=237): 12% | MOUNJARO 10 mg (n=240): 13% | MOUNJARO 15 mg (n=241): 17% | PLACEBO (n=235): 9% |
| Decreased appetite | MOUNJARO 5 mg (n=237): 5% | MOUNJARO 10 mg (n=240): 10% | MOUNJARO 15 mg (n=241): 11% | PLACEBO (n=235): 1% |
| Vomiting | MOUNJARO 5 mg (n=237): 5% | MOUNJARO 10 mg (n=240): 5% | MOUNJARO 15 mg (n=241): 9% | PLACEBO (n=235): 2% |
| Constipation | MOUNJARO 5 mg (n=237): 6% | MOUNJARO 10 mg (n=240): 6% | MOUNJARO 15 mg (n=241): 7% | PLACEBO (n=235): 1% |
| Dyspepsia | MOUNJARO 5 mg (n=237): 8% | MOUNJARO 10 mg (n=240): 8% | MOUNJARO 15 mg (n=241): 5% | PLACEBO (n=235): 3% |
| Abdominal pain | MOUNJARO 5 mg (n=237): 6% | MOUNJARO 10 mg (n=240): 5% | MOUNJARO 15 mg (n=241): 5% | PLACEBO (n=235): 4% |
The majority of reported nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time1
This table shows common adverse reactions, excluding hypoglycemia, associated with the use of Mounjaro in the pool of phase 3 placebo-controlled trials. These adverse reactions occurred more commonly with Mounjaro than placebo and in at least 5% of patients treated with Mounjaro. Percentages reflect the number of patients who reported at least 1 treatment-emergent occurrence of the adverse reaction.
In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro than placebo (placebo 20.4%, Mounjaro 5 mg 37.1%, Mounjaro 10 mg 39.6%, Mounjaro 15 mg 43.6%).1
Percentage of patients who discontinued treatment due to GI adverse reactions, placebo-controlled trials1
| MOUNJARO 5 mg (n=237) | MOUNJARO 10 mg (n=240) | MOUNJARO 15 mg (n=241) | PLACEBO (n=235) | |
|---|---|---|---|---|
| Discontinuation rates (%) | MOUNJARO 5 mg (n=237): 3.0% | MOUNJARO 10 mg (n=240): 5.4% | MOUNJARO 15 mg (n=241): 6.6% | PLACEBO (n=235): 0.4% |
Select Important Safety Information
Severe Gastrointestinal Disease: Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Incidence of hypoglycemia with Mounjaro in placebo-controlled trials1
Hypoglycemia adverse reactions in a placebo-controlled monotherapy trial, 40 weeks1#
| MOUNJARO 5 mg (n=121) | MOUNJARO 10 mg (n=119) | MOUNJARO 15 mg (n=120) | PLACEBO (n=115) | |
|---|---|---|---|---|
| Severe hypoglycemia** (%) | MOUNJARO 5 mg (n=121): 0 | MOUNJARO 10 mg (n=119): 0 | MOUNJARO 15 mg (n=120): 0 | PLACEBO (n=115): 0 |
| Blood glucose level <54 mg/dL (%) | MOUNJARO 5 mg (n=121): 0 | MOUNJARO 10 mg (n=191): 0 | MOUNJARO 15 mg (n=120): 0 | PLACEBO (n=115): 1 |
Hypoglycemia adverse reactions in a placebo-controlled trial as add-on to basal insulin with or without metformin, 40 weeks1#
| MOUNJARO 5 mg (n=116) | MOUNJARO 10 mg (n=119) | MOUNJARO 15 mg (n=120) | PLACEBO (n=120) | |
|---|---|---|---|---|
| Severe hypoglycemia** (%) | MOUNJARO 5 mg (n=116): 0 | MOUNJARO 10 mg (n=119): 2 | MOUNJARO 15 mg (n=120): 1 | PLACEBO (n=120): 0 |
| Blood glucose level <54 mg/dL (%) | MOUNJARO 5 mg (n=116): 16 | MOUNJARO 10 mg (n=119): 19 | MOUNJARO 15 mg (n=120): 14 | PLACEBO (n=120): 13 |
#Reflects the study treatment period. Data include events occurring during 4 weeks of treatment-free safety follow-up. Events after introduction of a new glucose-lowering treatment are excluded.
**Episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Hypoglycemia was more frequent when Mounjaro was used in combination with a sulfonylurea. In a clinical trial up to 104 weeks of treatment, when administered with a sulfonylurea, severe hypoglycemia occurred in 0.5%, 0%, and 0.6%, and hypoglycemia (glucose level <54 mg/dL) occurred in 13.8%, 9.9%, and 12.8% of patients treated with Mounjaro 5 mg, 10 mg, and 15 mg, respectively.1
GI=gastrointestinal.
Select Important Safety Information
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported in patients treated with Mounjaro. If hypersensitivity reactions occur, discontinue use of Mounjaro; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Mounjaro.
Common adverse events in a trial of Mounjaro vs Ozempic 1 mg3
ADVERSE EVENTS OCCURRING IN ≥5% OF MOUNJARO-TREATED PATIENTS3
| MOUNJARO 5 mg (n=470) % | MOUNJARO 10 mg (n=469) % | MOUNJARO 15 mg (n=470) % | OZEMPIC 1 mg (n=469) % | |
|---|---|---|---|---|
| Nausea | MOUNJARO 5 mg (n=470): 17% | MOUNJARO 10 mg (n=469): 19% | MOUNJARO 15 mg (n=470): 22% | OZEMPIC 1 mg (n=469): 18% |
| Diarrhea | MOUNJARO 5 mg (n=470): 13% | MOUNJARO 10 mg (n=469): 16% | MOUNJARO 15 mg (n=470): 14% | OZEMPIC 1 mg (n=469): 12% |
| Vomiting | MOUNJARO 5 mg (n=470): 6% | MOUNJARO 10 mg (n=469): 9% | MOUNJARO 15 mg (n=470): 10% | OZEMPIC 1 mg (n=469): 8% |
| Dyspepsia | MOUNJARO 5 mg (n=470): 7% | MOUNJARO 10 mg (n=469): 6% | MOUNJARO 15 mg (n=470): 9% | OZEMPIC 1 mg (n=469): 7% |
| Decreased appetite | MOUNJARO 5 mg (n=470): 7% | MOUNJARO 10 mg (n=469): 7% | MOUNJARO 15 mg (n=470): 9% | OZEMPIC 1 mg (n=469): 5% |
| Abdominal pain | MOUNJARO 5 mg (n=470): 3% | MOUNJARO 10 mg (n=469): 5% | MOUNJARO 15 mg (n=470): 5% | OZEMPIC 1 mg (n=469): 5% |
| Constipation | MOUNJARO 5 mg (n=470): 7% | MOUNJARO 10 mg (n=469): 5% | MOUNJARO 15 mg (n=470): 5% | OZEMPIC 1 mg (n=469): 6% |
PERCENTAGE OF PATIENTS WHO DISCONTINUED TREATMENT DUE TO GI ADVERSE EVENTS4
| MOUNJARO 5 mg (n=470) | MOUNJARO 10 mg (n=469) | MOUNJARO 15 mg (n=470) | OZEMPIC 1 mg (n=469) | |
|---|---|---|---|---|
| Discontinuation rate (%) | MOUNJARO 5 mg (n=470): 2.8 | MOUNJARO 10 mg (n=469): 4.3 | MOUNJARO 15 mg (n=470): 4.3 | OZEMPIC 1 mg (n=469): 3.2 |
Incidence of hypoglycemia in a 40-week trial of Mounjaro vs.Ozempic 1 mg3
Hypoglycemic Adverse Events in a 40-Week Trial of Mounjaro vs. Ozempic 1 mg3
| Mounjaro 5 mg (n=470) | Mounjaro 10 mg (n=469) | Mounjaro 15 mg (n=470) | Ozempic 1 mg (n=469) | |
|---|---|---|---|---|
| Add-on to metformin | ||||
| Severe Hypoglycemia** (%) | Mounjaro 5 mg (n=470): 0.2 | Mounjaro 10 mg (n=469): 0 | Mounjaro 15 mg (n=470): 0.2†† | Ozempic 1 mg (n=469): 0 |
| Blood glucose level <54 mg/dL (%) | Mounjaro 5 mg (n=470): 0.6 | Mounjaro 10 mg (n=469): 0.2 | Mounjaro 15 mg (n=470): 1.7 | Ozempic 1 mg (n=469): 0.4 |
SURPASS-2 was not designed to evaluate the relative safety between Mounjaro and Ozempic 1 mg. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
**Episodes requiring the assistance of another person to actively administer carbohydrate, glucose, or other resuscitative actions.
††One patient had a hypoglycemic event that was not considered by the investigator to be severe, but it was reported as a serious adverse event.
GI=gastrointestinal.
Select Important Safety Information
Acute Kidney Injury: Mounjaro has been associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhea. These events may lead to dehydration, which if severe could cause acute kidney injury. In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis. Some of these events have been reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Mounjaro in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Severe Gastrointestinal Disease: Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Mounjaro vs Ozempic (+ metformin) Study Design
- SURPASS-2 was a 40-week, open-label (double-blind with respect to Mounjaro dose assignment), active-controlled, phase 3 trial that randomized 1879 adult patients with T2D who had inadequate glycemic control on stable doses of metformin alone to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg or once-weekly SC Ozempic® 1 mg (1:1:1:1 ratio), all in combination with metformin ≥1500 mg per day1,3
- The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg in Ozempic in mean change from baseline in A1C at 40 weeks3
- The key secondary objectives were assessed at 40 weeks: noninferiority of Mounjaro 5 mg to Ozempic in mean change from baseline in A1C; superiority of Mounjaro to Ozempic in mean change from baseline in A1C; superiority of proportion of patients with A1C <7%; superiority in mean change from baseline in weight; superiority of Mounjaro 10 mg and/or 15 mg to Ozempic in proportion of patients with A1C <5.7%3
- Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years1,3
SC=subcutaneous.
Mounjaro demonstrated significant weight reduction across all 3 doses vs Ozempic 1 mg1‡‡
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
IN ADULT PATIENTS WITH T2D ON METFORMIN
Mounjaro vs Ozempic 1 mg Study length: 40 weeks
CHANGE IN WEIGHT FROM BASELINE ACROSS DOSES (LB)1,9
Bar chart depicting change in weight from baseline at 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and the mean baseline weights were 203.9 lb, 209.0 lb, 206.8 lb, and 206.6 lb, respectively. Mean changes in weight at 40 weeks were -17 lb or -8.2% (p<0.05 for superiority vs. Ozempic, adjusted for multiplicity), -21 lb or -10.0% (p<0.001 for superiority vs. Ozempic, adjusted for multiplicity), -25 lb or -11.8% (p<0.001 for superiority vs. Ozempic, adjusted for multiplicity), and -13 lb or -6.2% for Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg, respectively.
‡‡In other studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in body weight ranged from 12 lb to 15 lb for the 5-mg dose; 15 lb to 21 lb for the 10-mg dose, and 17 lb to 25 lb for the 15-mg dose.1
Select Important Safety Information
Severe Gastrointestinal Disease: Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Drug Interactions: When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.
Patients taking Mounjaro experienced sustained weight reductions through 40 weeks1,3,10§§||||
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
IN ADULT PATIENTS WITH T2D ON METFORMIN
OBSERVED MEAN CHANGE IN WEIGHT OVER TIME FROM BASELINE TO 40 WEEKS (lb)1,3,10
Line graph depicting mean weight over time to 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and the mean baseline weights were 203.9 lb, 209.0 lb, 206.8 lb, and 206.6 lb, respectively. The observed mean change in weight at 40 weeks was -17.6 lb, -21.1 lb, -25.5 lb, and -13.3 lb for Mounjaro 5 mg (n=450), 10 mg (n=443), 15 mg (n=448), and Ozempic 1 mg (n=444), respectively. The least-squares mean change in weight at 40 weeks with multiple imputation was -16.8 lb, -20.5 lb, -24.7 lb, and -12.6 lb for Mounjaro 5 mg (n=470), 10 mg (n=469), 15 mg (n=469), and Ozempic 1 mg (n=468), respectively.
Patients taking Mounjaro had weight reductions§§,‖‖ that continued through 40 weeks1,3,10
§§In other studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in body weight ranged from 12 lb to 15 lb for the 5-mg dose; 15 lb to 21 lb for the 10-mg dose, and 17 lb to 25 lb for the 15-mg dose.1
||||Data represent observed mean changes from week 0 to week 40, and least-squares mean at week 40 MI. mITT population, full analysis set. ANCOVA was performed for change from baseline at week 40 and MMRM analysis was performed for change over time.
Select Important Safety Information
Pregnancy: Limited data on Mounjaro use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.
Percentage of patients with weight reduction at 40 weeks3¶¶
Mounjaro is not indicated for weight loss.
IN ADULT PATIENTS WITH T2D ON METFORMIN
Percentage of patients with weight reduction ≥10%1,3
Mounjaro vs Ozempic 1 mg
Study length: 40 weeks
Bar chart depicting proportion of patients with weight reduction ≥10% at 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and the mean baseline weights were 203.9 lb, 209.0 lb, 206.8 lb, and 206.6 lb, respectively. The proportion with weight reduction ≥10% at 40 weeks was 34%, 47%, 57%, and 24% for Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg, respectively.
Percentage of patients with weight reduction ≥15%1,3##
Mounjaro vs Ozempic 1 mg
Study length: 40 weeks
Bar chart depicting proportion of patients with weight reduction ≥15% at 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and the mean baseline weights were 203.9 lb, 209.0 lb, 206.8 lb, and 206.6 lb, respectively. The proportion with weight reduction ≥15% at 40 weeks was 15%, 24%, 36%, and 8% for Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg, respectively.
¶¶In clinical studies, the percentage of patients with weight reduction ≥10% was an additional secondary endpoint not controlled for type I error. Proportions were determined using logistic regression with multiple imputation using retrieved dropout for missing value at 40 weeks.3
##In clinical studies, the percentage of patients with weight reduction ≥15% was an additional secondary endpoint not controlled for type I error. Proportions were determined using logistic regression with multiple imputation using retrieved dropout for missing value at 40 weeks.3
Select Important Safety Information
Lactation: There are no data on the presence of tirzepatide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mounjaro and any potential adverse effects on the breastfed infant from Mounjaro or from the underlying maternal condition.
Mounjaro vs Ozempic (+ metformin) Study Design
- SURPASS-2 was a 40-week, open-label (double-blind with respect to Mounjaro dose assignment), active-controlled, phase 3 trial that randomized 1879 adult patients with T2D who had inadequate glycemic control on stable doses of metformin alone to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg or once-weekly SC Ozempic® 1 mg (1:1:1:1 ratio), all in combination with metformin ≥1500 mg per day1,3
- The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to Ozempic in mean change from baseline in A1C at 40 weeks3
- The key secondary objectives were assessed at 40 weeks: noninferiority of Mounjaro 5 mg to Ozempic in mean change from baseline in A1C; superiority of Mounjaro to Ozempic in mean change from baseline in A1C; superiority of proportion of patients with A1C <7%; superiority in mean change from baseline in weight; superiority of Mounjaro 10 mg and/or 15 mg to Ozempic for proportion of patients with A1C <5.7%3
- Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years1,3
Composite endpoint results3***†††
Mounjaro is not indicated for weight loss.
Chart depicting proportion of patients with a composite endpoint of A1C ≤6.5% + weight reduction ≥10% + no clinically significant or severe hypoglycemic events at 40 weeks. There were 470, 469, 469, and 468 patients in the Mounjaro 5 mg, 10 mg, 15 mg, and Ozempic 1 mg treatment groups, respectively, and 32%, 51%, 60%, and 22% of patients, respectively, had this composite endpoint at 40 weeks.
***In SURPASS-2, composite outcome was a prespecified secondary endpoint not controlled for type I error. Analysis based on efficacy estimand data (on-treatment efficacy without the influence of rescue therapy).
†††Clinically significant hypoglycemia defined as plasma glucose <54 mg/dL. Severe hypoglycemia defined as episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Select Important Safety Information
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Mounjaro vs Ozempic (+ metformin) Study Design
- SURPASS-2 was a 40-week, open-label (double-blind with respect to Mounjaro dose assignment), active-controlled, phase 3 trial that randomized 1879 adult patients with T2D who had inadequate glycemic control on stable doses of metformin alone to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg or once-weekly SC Ozempic® 1 mg (1:1:1:1 ratio), all in combination with metformin ≥1500 mg per day1,3
- The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to Ozempic in mean change from baseline in A1C at 40 weeks3
- The key secondary objectives were assessed at 40 weeks: noninferiority of Mounjaro 5 mg to Ozempic in mean change from baseline in A1C; superiority of Mounjaro to Ozempic in mean change from baseline in A1C; superiority of proportion of patients with A1C <7%; superiority in mean change from baseline in weight; superiority of Mounjaro 10 mg and/or 15 mg to Ozempic in proportion of patients with A1C <5.7%3
- Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years1,3
Mounjaro delivered superior A1C reductions when studied across a range of background therapies and comparators.1‡‡‡
A1C reductions were consistently seen across studies vs Ozempic 1 mg1, Tresiba® (insulin degludec)§§§, insulin glargine||||||, and placebo.
Reductions in A1C From Baseline (%) Across Doses and Trials1
‡‡‡SURPASS study participants were adults on monotherapy, up to 3 orals, or basal insulin. They had a mean baseline A1C that ranged from 7.9% to 8.6%, and a mean duration of T2D that ranged from 4.7 to 13.3 years.1
§§§At week 52, 26% of patients randomized to Tresiba achieved the fasting serum glucose target of <90 mg/dL, and the mean daily Tresiba dose was 49 U (0.5 U/kg).1
||||||At week 52, 30% of patients randomized to insulin glargine achieved the fasting serum glucose target of <100 mg/dL, and the mean daily insulin glargine dose was 44 U (0.5 U/kg).1
§§§In other studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in A1C with Mounjaro ranged from 1.8% to 2.1% for the 5-mg dose, 1.7% to 2.4% for the 10-mg dose, and 1.7% to 2.4% for the 15-mg dose.1
†††At week 52, 26% of patients randomized to Tresiba achieved the fasting serum glucose target of <90 mg/dL, and the mean daily Tresiba dose was 49 U (0.5 U/kg).1
‡‡‡At week 52, 30% of patients randomized to insulin glargine achieved the fasting serum glucose target of <100 mg/dL, and the mean daily insulin glargine dose was 44 U (0.5 U/kg).1
The primary endpoint was mean change in A1C from baseline at 40 weeks for SURPASS-1, SURPASS-2, and SURPASS-5 and at 52 weeks for SURPASS-3 and SURPASS-4.
OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor.
Select Important Safety Information
Pediatric Use: Safety and effectiveness of Mounjaro have not been established and use is not recommended in patients less than 18 years of age.
Mounjaro demonstrated significant weight results across 5 clinical trials1
Mounjaro consistently demonstrated weight reduction in adult patients with type 2 diabetes across studies vs Ozempic 1 mg, Tresiba, insulin glargine, and placebo.1
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
Change in Weight From Baseline Across Doses (lb)1
OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor.
Select Important Safety Information
Pregnancy: Limited data on Mounjaro use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.
Study Designs
Mounjaro vs placebo
- SURPASS-1 was a 40-week, double-blind, placebo-controlled, phase 3 trial that randomized 478 adult patients with T2D who had inadequate glycemic control with diet and exercise to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg, or placebo (1:1:1:1 ratio)1,5
- The primary objective was to demonstrate superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to placebo in mean change from baseline in A1C at 40 weeks5
- The key secondary objectives were assessed at 40 weeks: superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to placebo in proportion of patients with A1C <7% and <5.7%, mean change from baseline in fasting serum glucose, and mean change from baseline in weight5
- Study participants had a mean baseline A1C of 7.9% and mean T2D duration of 4.7 years1,5
Mounjaro vs Ozempic (+ metformin)
- SURPASS-2 was a 40-week, open-label (double-blind with respect to Mounjaro dose assignment), active-controlled, phase 3 trial that randomized 1879 adult patients with T2D who had inadequate glycemic control on stable doses of metformin alone to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg or once-weekly SC Ozempic® 1 mg (1:1:1:1 ratio), all in combination with metformin ≥1500 mg per day1,3
- The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to Ozempic in mean change from baseline in A1C at 40 weeks3
- The key secondary objectives were assessed at 40 weeks: noninferiority of Mounjaro 5 mg to Ozempic in mean change from baseline in A1C; superiority of Mounjaro to Ozempic in mean change from baseline in A1C; superiority of proportion of patients with A1C <7%; superiority in mean change from baseline in weight; superiority of Mounjaro 10 mg and/or 15 mg to Ozempic for proportion of patients with A1C <5.7%3
- Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years1,3
Mounjaro vs Tresiba (+ metformin ± SGLT2i)
- SURPASS-3 was a 52-week, open-label, active-controlled, phase 3 trial that randomized 1444 adult patients with T2D who had inadequate glycemic control on stable doses of metformin with or without an SGLT2i to once-weekly SC Mounjaro 5 mg, 10 mg, 15 mg, or once-daily SC Tresiba 100 U/mL (1:1:1:1 ratio)1,6
- Tresiba was initiated at 10 U/day and titrated to a fasting blood glucose of <90 mg/dL using a treat-to-target algorithm. At week 52, the mean daily Tresiba dose was 49 U (0.5 U/kg), and 26% of patients achieved the target fasting serum glucose.6
- The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to Tresiba in mean change from baseline in A1C at 52 weeks6
- The key secondary objectives were assessed at 52 weeks: noninferiority of Mounjaro 5 mg to Tresiba in mean change from baseline in A1C and superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to Tresiba in mean change from baseline in A1C, mean change from baseline in weight, and proportion of patients with A1C <7%6
- Study participants had a mean baseline A1C of 8.2% and a mean T2D duration of 8.4 years6
Mounjaro vs insulin glargine (+ 1-3 OAMs)
- SURPASS-4 was a 104-week, open-label, active-controlled, phase 3 trial that randomized 2002 adult patients with T2D who had increased cardiovascular risk to once-weekly SC Mounjaro 5 mg, 10 mg, 15 mg, or once-daily SC insulin glargine 100 U/mL (1:1:1:3 ratio), on background metformin (95%), and/or sulfonylureas (54%) and/or an SGLT2i (25%)1,7
- Insulin glargine was initiated at 10 U/day and titrated to a fasting blood glucose of <100 mg/dL using a treat-to-target algorithm; dose adjustments were made based on the median value of the last 3 self-monitored fasting blood glucose values. At week 52, 30% of patients achieved the target fasting serum glucose, and the mean daily insulin glargine dose was 44 U (0.5 U/kg)7
- The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to insulin glargine in mean change from baseline in A1C at 52 weeks7
- The key secondary objectives were assessed at 52 weeks: noninferiority of Mounjaro 5 mg to insulin glargine in mean change from baseline in A1C and superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to insulin glargine in mean change from baseline in A1C, mean change from baseline in weight, and proportion of patients with A1C <7%7
- Study participants had a mean baseline A1C of 8.5% and a mean duration of T2D of 11.8 years7
Mounjaro vs placebo (+ insulin glargine ‡ metformin)
- SURPASS-5 was a 40-week, double-blind, placebo-controlled, phase 3 trial that randomized 475 adult patients with T2D who had inadequate glycemic control on insulin glargine 100 U/mL, with or without metformin (≥1500 mg/day), to receive once-weekly SC Mounjaro 5 mg, 10 mg, 15 mg, or placebo (1:1:1:1 ratio)1,8
- The background dose of insulin glargine was titrated to a fasting blood glucose of <100 mg/dL using a treat-to-target algorithm. The mean starting dose of insulin glargine was 34 U/day, 32 U/day, 35 U/day, and 33 U/day for patients on Mounjaro 5 mg, 10 mg, 15 mg, and placebo, respectively. At randomization, the initial insulin glargine dose in patients with A1C ≤8.0% was reduced by 20%. At 40 weeks, the mean dose of insulin glargine was 38 U/day, 36 U/day, 29 U/day, and 59 U/day for patients on Mounjaro 5 mg, 10 mg, 15 mg, and placebo, respectively1
- The primary objective was to demonstrate superiority of Mounjaro 10 mg and/or 15 mg to placebo in mean change from baseline in A1C at 40 weeks8
- The key secondary objectives were assessed at 40 weeks: superiority of Mounjaro 5 mg to placebo in mean change from baseline in A1C, and superiority of Mounjaro to placebo in proportion of patients with A1C <7% (Mounjaro 5 mg, 10 mg, and 15 mg) and <5.7% (Mounjaro 10 mg and 15 mg), mean change from baseline in fasting serum glucose, and mean change from baseline in weight1,8
- Study participants had a mean baseline A1C of 8.3% and mean T2D duration of 13.3 years1,8
QD=once daily; QW=once weekly.
See the composite endpoint that measured A1C, weight, and hypoglycemia
DISCOVER THE DATAReferences:
- Mounjaro. Prescribing Information. Lilly USA, LLC.
- American Diabetes Association. Standards of medical care in diabetes-2021. Diabetes Care. 2021;44(suppl 1):S1-S232.
- Frías JP, Davies MJ, Rosenstock J, et al.; for the SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515.
- Data on File. Lilly USA, LLC. DOF-TR-US-0003.
- Rosenstock 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.
- Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598.
- Del Prato S, Kahn SE, Pavo I, et al.; for the SUPRASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824.
- Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545.
- Data on File. Lilly USA, LLC. DOF-TR-US-0007.
- Data on File. Lilly USA, LLC. DOF-TR-US-0014.