Reset Your Expectations with Mounjaro1*
Mounjaro vs Ozempic 1 mg A1C Data
Mounjaro vs Ozempic 1 mg Weight Data
Real-World Evidence ||| own-line
Discuss the data with a peer ||| own-line
Every dose of Mounjaro is superior to Ozempic® (semaglutide) 1 mg in reducing A1C1* | mounjaro-vs-ozempic-1-mg-A1C-data
The primary endpoint was mean change in A1C from baseline at 40 weeks.
IN ADULT PATIENTS WITH TYPE 2 DIABETES (T2D) ON METFORMIN
Select Important Safety Information
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.
Sustained 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
*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; and for comparators, 0.1% and 0.9% for placebo, 1.3% for Tresiba®, and 1.4% for insulin glargine.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.
Select Important Safety Information
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.
Significantly more patients achieved the ADA guideline-recommended A1C target of <7%†ǂ with Mounjaro 10 mg and 15 mg1,2
The primary endpoint was mean change in A1C from baseline at 40 weeks.
IN ADULT PATIENTS WITH T2D ON METFORMIN
†The ADA states that an A1C target of <7% (53 mmol/mol) is appropriate for many nonpregnant adults without significant hypoglycemia.2
ǂKey secondary endpoint controlled for type I error. Logistic regression adjusted for baseline value and other stratification factors.
Select Important Safety Information
Pancreatitis ||| mounjaro-purple
Acute pancreatitis, including fatal and non-fatal 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.
Percentage of patients with A1C ≤6.5% and <5.7%1,3
The primary endpoint was mean change in A1C from baseline at 40 weeks.
IN ADULT PATIENTS WITH T2D ON METFORMIN
*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.
†Proportion of participants with A1C <5.7% was evaluated as a key secondary endpoint (controlled for type I error) for the 10-mg and 15-mg doses, and as an additional secondary endpoint (not controlled for type I error) for the 5-mg dose. Logistic regression adjusted for baseline value and other stratification factors, with multiple imputation using retrieved dropout for missing value at 40 weeks.
‡A1C <5.7% is not a treatment goal supported by current treatment guidelines.
T2D=type 2 diabetes.
Select Important Safety Information
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin ||| mounjaro-purple
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.
Common adverse reactions in placebo-controlled trials1 | safety-profile
Adverse reactions in pool of placebo-controlled trials reported in ≥5% of Mounjaro-treated patients1
Percentage of patients who discontinued treatment due to GI adverse reactions, placebo-controlled trials1
Select Important Safety Information
Severe Gastrointestinal Adverse Reactions ||| mounjaro-purple
Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%). 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#
Hypoglycemia adverse reactions in a placebo-controlled trial as add-on to basal insulin with or without metformin, 40 weeks1#
#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 ||| mounjaro-purple
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 ||| mounjaro-purple
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
Percentage of patients who discontinued treatment due to GI Adverse Events4
Hypoglycemic Adverse Events in a 40-Week Trial of Mounjaro vs Ozempic 1 mg3
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.
bOne 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-purple
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 Adverse Reactions ||| mounjaro-purple
Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%). Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Discover Lilly Play
Watch videos about Mounjaro and how to help your patients get started.
Unmatched weight reduction* across all 3 doses vs Ozempic 1 mg1 | mounjaro-ozempic-wgt-data
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
IN ADULT PATIENTS WITH T2D ON METFORMIN
*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; and for comparators, mean change was -2 lb and +4 lb for placebo, +4 lb for Tresiba®, and +4 lb for insulin glargine.1
Select Important Safety Information
Severe Gastrointestinal Adverse Reactions ||| mounjaro-purple
Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%). Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Drug Interactions ||| mounjaro-purple
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 weeks1,3,6*†
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
IN ADULT PATIENTS WITH T2D ON METFORMIN
†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.
mITT=modified intent to treat
ANCOVA=analysis of covariance
MMRM=mixed model repeated measures
Select Important Safety Information
Pregnancy ||| mounjaro-purple
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.
Request a peer-to-peer education on clinical data | request-peer
https://main--ewi-mounjaro-aem-us--elilillyco.aem.page/fragments/forms/clinical-data
Percentage of patients with weight reduction at 40 weeks3
Mounjaro is not indicated for weight loss.
IN ADULT PATIENTS WITH T2D ON METFORMIN
Mounjaro is not indicated for weight loss
†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.1
Select Important Safety Information
Lactation ||| mounjaro-purple
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.
Subgroup analysis of mean weight change by baseline BMI7
Mounjaro is not indicated for weight loss.
Post Hoc Analysis: Mean weight change from baseline (40 weeks)7
Patients With Baseline BMI <30 kg/m2
Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use: Mounjaro has not been studied in patients with a history of pancreatitis. Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.1
In SURPASS-2, change in weight by baseline BMI at 40 weeks was a secondary endpoint not controlled for type I error.
LSM change was estimated using MMRM with treatment, visit, treatment-by-visit interaction, pooled country, baseline A1C group, baseline OAM (when appropriate), and baseline weight as fixed effects, and patient as random effect.8
BMI=body mass index; LSM=least-squares mean; MMRM=mixed model for repeated measures; OAM=oral antihyperglycemic medication.
Help get your patients started on Mounjaro
Composite endpoint of A1C ≤6.5%, weight reduction ≥10%, and no clinically significant or severe hypoglycemia3,9* | composite-endpoint
Mounjaro is not indicated for weight loss.
aClinically 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.3
*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) and may not represent a real-world setting. The number of patients included in the efficacy analysis data set for Mounjaro 5 mg, 10 mg, 15 mg and Ozempic 1 mg were 470, 469, 469, and 468, respectively. Only participants with baseline value and at least one post-baseline value for the response variables were included in the analysis.9
Select Important Safety Information
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin ||| mounjaro-purple
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 oncomitantly 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 delivered superior A1C reductions when studied across a range of background therapies and comparators1* | cross-trial-data
Data represent least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.1
aAt 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
bAt 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
cp<0.001 for superiority vs comparator, adjusted for multiplicity.
dp<0.05 for superiority vs Ozempic 1 mg, adjusted for multiplicity.
*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
ANCOVA=analysis of covariance; OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor; T2D=type 2 diabetes.
Mounjaro demonstrated significant weight results across 5 clinical trials1
Mounjaro is not indicated for weight loss.
Change in weight was a secondary endpoint.
Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
a<0.001 for superiority vs comparator, adjusted for multiplicity.
b<0.05 for superiority vs comparator, adjusted for multiplicity.
OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor.
Select Important Safety Information
Pregnancy ||| mounjaro-purple
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.
Explore Clinical Trial Results and Real-World Data for Mounjaro | real-world-evidence
Mounjaro real-world evidence: Mean changes in A1C and weight with Mounjaro and Ozempic® in adults with T2D10-12
Doses were pooled for Mounjaro up to 15 mg and for Ozempic up to 2 mg
Patients with No Evidence of Previous GLP-1 RA Use
Patients with Previous GLP-1 RA Use
Effectiveness should be interpreted in the context of the limitations of this retrospective, observational study
Mounjaro is not indicated for weight loss.
Data from real-world evidence (RWE) study. RWE differs from evidence derived from interventional clinical trials in terms of study design and methodology, patient population, treatment assignment, outcomes assessed, and source of data. RWE should be viewed as complementary to interventional clinical trial results. Retrospective observational cohort study of adults with type 2 diabetes with commercial or Medicare Advantage (excluding Medicare Supplement Part D and California HMO) coverage initiating Mounjaro or Ozempic between May 13, 2022 and May 29, 2023 in the Healthcare Integrated Research Database (HIRD®). Patients were required to have six months of continuous medical and pharmacy benefit enrollment prior to and 12 months after initiation of Mounjaro or Ozempic. Patients were stratified according to prior use of oral or injectable GLP-1 RA in the 6 months prior to initiation of the index treatment (index). Doses of Mounjaro (2.5 mg to 15 mg) and Ozempic (0.25 mg to 2 mg) were pooled for analysis. Baseline characteristics were balanced using propensity score matching across cohorts. Patients with ≥1 valid A1C or weight value during the baseline and outcome assessment periods were included in the analyses of A1C and weight outcomes. Analyses were performed on the subgroup of patients with non-missing baseline and follow-up data.
A1C=glycated hemoglobin; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HMO=health maintenance organization; T2D=type 2 diabetes.
Select Important Safety Information
Lactation ||| mounjaro-purple
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.
Study Designs | 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)1,13
- 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 weeks13
- 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 weight13
- Study participants had a mean baseline A1C of 7.9% and mean T2D duration of 4.7 years1,13
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)1,14
- 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.14
- 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 weeks14
- 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%14
- Study participants had a mean baseline A1C of 8.2% and a mean T2D duration of 8.4 years14
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%)1,15
- 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)15
- 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 weeks15
- 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%15
- Study participants had a mean baseline A1C of 8.5% and a mean duration of T2D of 11.8 years15
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)1,16
- 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, respectively16
- 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 weeks16
- 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 weight1,16
- Study participants had a mean baseline A1C of 8.3% and mean T2D duration of 13.3 years1,16
Real-World Use of Mounjaro and Ozempic®10-12 | real-world-evidence-sd
- Retrospective, observational, US cohort study of adults with commercial or Medicare Advantage (excluding Medicare Supplement Part D and California HMO) coverage with T2D initiating Mounjaro or Ozempic once weekly with or without prior use of GLP-1 RAs in the 6 months prior to index date (initiation of index treatment) in the Healthcare Integrated Research Database (HIRD®)
- Patients were ≥18 years of age on index date, had evidence of T2D diagnosis, had ≥1 pharmacy claim for Mounjaro or Ozempic from 13 May 2022 to 29 May 2023, had continuous enrollment during a 6-month pre-index and 12-month post-index period; and had no claims for other forms of diabetes during the 6-month pre-index period, no claims for bariatric or other procedures for obesity during the full pre-index period and 12-month post-index period, and had no claims for pregnancy, labor, and delivery in the 6-month pre index and 12-month post-index period
- Primary outcome was change in A1C and weight at 12 months of follow-up. Secondary outcomes were percent change in weight, proportion of patients with A1C ≤6.5%, proportion of patients with A1C <5.7%, cost per responder with A1C ≤6.5%, and proportion of patients adherent to medication at 12 months of follow-up
- Patients were stratified according to prior use of oral or injectable GLP-1 RAs in the 6-month pre-index period and then matched using propensity score adjustment. Patients were included in the analyses of A1C and weight if they had ≥1 valid A1C or weight value during the baseline and outcome assessment periods. Missing values were not imputed. Analyses were performed on patients with non-missing data. Doses of Mounjaro (2.5 mg to 15 mg) were pooled and doses of Ozempic (0.25 mg to 2 mg) were pooled for analysis. Changes in A1C and weight were assessed from baseline (90 days before to 14 days after index) to follow-up (index + 320 days to index + 410 days)
- At 12 months, for patients with no evidence of GLP-1 RA use in the prior 6 months, the use of Mounjaro for all eligible patients was 2.5 mg: 2%, 5 mg: 7%, 7.5 mg: 9%, 10 mg: 7%, 12.5 mg: 5%, 15 mg: 5%, and no fill: 66%, and the use of Ozempic for all eligible patients was 0.5 mg: 3%, 1 mg: 7%, 2 mg: 5%, and no fill: 84%
- At 12 months, for patients with previous GLP-1 RA use, the use of Mounjaro for all eligible patients was 2.5 mg: 1%, 5 mg: 5%, 7.5 mg: 8%, 10 mg: 8%, 12.5 mg: 6%, 15 mg: 6%, and no fill 66%, and the use of Ozempic for all eligible patients was 0.5 mg: 1%, 1 mg: 6%, 2 mg: 7%, and no fill: 86%
- Limitations when interpreting the results: propensity-score matching may not account for all potential confounders; this was a retrospective database analysis and not all confounding variables may have been collected in the database; administrative and pharmacy claims may not accurately reflect actual diagnoses and treatments; patients in the study were enrolled in commercial health insurance plans in the US and results may not be generalizable; requirement for continuous enrollment may result in selection bias; a small number of patients were excluded due to post-index events, which may bias results.
References:
- Mounjaro. Prescribing Information. Lilly USA, LLC
- American Diabetes Association. Professional Practice Committee. 6. Glycemic goals and hypoglycemia: Standards of care in diabetes—2024. Diabetes Care. 2024;47(suppl 1):S111-S125.
- 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.
- Data on File. Lilly USA, LLC. DOF-TR-US-0007.
- Data on File. Lilly USA, LLC. DOF-TR-US-0014.
- Data on File. Lilly USA, LLC. DOF-TR-US-0048.
- Kwan A, Maldonado JM, Wang H, Rasouli N, Wilding J. 719-P: Tirzepatide induces weight loss in patients with type 2 diabetes regardless of baseline BMI: a post hoc analysis of SURPASS-1 through -5 studies. Diabetes. 2022;71(suppl 1):719-P.
- Data on File. Lilly USA, LLC. DOF-TR-US-0031.
- Data on File. Lilly USA, LLC. DOF-TR-US-0054.
- Terrell K, Vallarino CR, Maldonado Lozada J, et al. Real-world effectiveness of tirzepatide vs. semaglutide on HbA1c and weight in GLP-1 RA naïve patients with T2D [abstract]. Value Health. 2025;28(Suppl 1):CO23.
- Hoog MM, Vallarino CR, Maldonado Lozada J, et al. Real-world effectiveness of tirzepatide vs. semaglutide on HbA1c and weight in GLP-1 RA experienced patients with T2D [abstract]. Value Health. 2025;28(Suppl 1):CO72.
- 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.