Mounjaro results
In SURMOUNT-1, mean weight change was -20.9% at 72 wks at 15 mg weekly (Zepbound); in SURPASS-2, A1c fell -2.3% at 40 wks. Below is what Mounjaro's own FDA label reports. Source.
Section 14, word for word, from the FDA label on DailyMed (Eli Lilly and Company), revised , version 40. Read every day: a new FDA version updates this page by itself.
What Mounjaro's clinical studies found
Overview of Clinical Studies
The effectiveness of MOUNJARO as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus was established in five trials. In these trials, MOUNJARO was studied as monotherapy (SURPASS-1); as an add-on to metformin, sulfonylureas, and/or sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors) (SURPASS-2, -3, and -4); and in combination with basal insulin with or without metformin (SURPASS-5). In these trials, MOUNJARO (5 mg, 10 mg, and 15 mg given subcutaneously once weekly) was compared with placebo, semaglutide 1 mg, insulin degludec, and/or insulin glargine [see Clinical Studies (14.2, 14.3, 14.4)] .
In adult patients with type 2 diabetes mellitus, treatment with MOUNJARO produced a statistically significant reduction from baseline in HbA1c compared to placebo. The effectiveness of MOUNJARO was not impacted by age, gender, race, ethnicity, region, or by baseline BMI, HbA1c, diabetes duration, or renal function.
MOUNJARO 5 mg and 10 mg was studied in pediatric patients 10 years of age and older with type 2 diabetes in combination with metformin and/or basal insulin [see Clinical Studies (14.5)] .
Monotherapy Use of MOUNJARO in Adult Patients with Type 2 Diabetes Mellitus
SURPASS-1 (NCT03954834) was a 40-week double-blind trial that randomized 478 adult patients with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise to subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, MOUNJARO 15 mg, or placebo once weekly.
Patients had a mean age of 54 years, and 52% were men. The mean duration of type 2 diabetes mellitus was 4.7 years, and the mean BMI was 32 kg/m 2 . Overall, 36% were White, 35% were Asian, 25% were American Indians/Alaska Natives, and 5% were Black or African American; 43% identified as Hispanic or Latino ethnicity.
Monotherapy with MOUNJARO 5 mg, 10 mg and 15 mg once weekly for 40 weeks resulted in a statistically significant reduction in HbA1c compared with placebo (see Table 4 ).
| Placebo | MOUNJARO 5 mg | MOUNJARO 10 mg | MOUNJARO 15 mg | |
| Modified Intent-to-Treat (mITT) Population (N) | 113 | 121 | 121 | 120 |
| HbA1c (%) | ||||
| Baseline (mean) | 8.1 | 8.0 | 7.9 | 7.9 |
| Change at Week 40 | -0.1 | -1.8 | -1.7 | -1.7 |
| Difference from placebo (95% CI) | -- | -1.7 (-2.0, -1.4) | -1.6 (-1.9, -1.3) | -1.6 (-1.9, -1.3) |
| Patients (%) achieving HbA1c <7% | 23 | 82 | 85 | 78 |
| Fasting Serum Glucose (mg/dL) | ||||
| Baseline (mean) | 155 | 154 | 153 | 154 |
| Change at Week 40 | 4 | -40 | -40 | -39 |
| Difference from placebo (95% CI) | -- | -43 (-55, -32) | -43 (-55, -32) | -42 (-54, -30) |
| Body Weight (kg) | ||||
| Baseline (mean) | 84.5 | 87.0 | 86.2 | 85.5 |
| Change at Week 40 | -1.0 | -6.3 | -7.0 | -7.8 |
| Difference from placebo (95% CI) | -- | -5.3 (-6.8, -3.9) | -6.0 (-7.4, -4.6) | -6.8 (-8.3, -5.4) |
a The modified intent-to-treat population consists of all randomly assigned participants who were exposed to at least 1 dose of study drug. Patients who discontinued study treatment because they did not meet study enrollment criteria were excluded. During the trial, rescue medication (additional antihyperglycemic medication) was initiated by 25%, 2%, 3%, and 2% of patients randomized to placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. At Week 40 the HbA1c data were missing for 12%, 6%, 7%, and 14% of patients randomized to placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. Missing Week 40 data were imputed using placebo-based multiple imputation.
b Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
c p<0.001 (two-sided) for superiority versus placebo, adjusted for multiplicity.
d Analyzed using logistic regression adjusted for baseline value and other stratification factors.
MOUNJARO Use in Combination with Metformin, Sulfonylureas, and/or SGLT2 Inhibitors in Adult Patients with Type 2 Diabetes Mellitus
Add-on to metformin
SURPASS-2 (NCT03987919) was a 40-week open-label trial (double-blind with respect to MOUNJARO dose assignment) that randomized 1,879 adult patients with type 2 diabetes mellitus with inadequate glycemic control on stable doses of metformin alone to the addition of subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, or MOUNJARO 15 mg once weekly or subcutaneous semaglutide 1 mg once weekly.
Patients had a mean age of 57 years and 47% were men. The mean duration of type 2 diabetes mellitus was 8.6 years, and the mean BMI was 34 kg/m 2 . Overall, 83% were White, 4% were Black or African American, and 1% were Asian; 70% identified as Hispanic or Latino ethnicity.
Treatment with MOUNJARO 10 mg and 15 mg once weekly for 40 weeks resulted in a statistically significant reduction in HbA1c compared with semaglutide 1 mg once weekly (see Table 5 and Figure 2 ).
| Semaglutide 1 mg | MOUNJARO 5 mg | MOUNJARO 10 mg | MOUNJARO 15 mg | |
| Modified Intent-to-Treat (mITT) Population (N) | 468 | 470 | 469 | 469 |
| HbA1c (%) | ||||
| Baseline (mean) | 8.3 | 8.3 | 8.3 | 8.3 |
| Change at Week 40 | -1.9 | -2.0 | -2.2 | -2.3 |
| Difference from semaglutide (95% CI) | -- | -0.2 (-0.3, -0.0) | -0.4 (-0.5, -0.3) | -0.5 (-0.6, -0.3) |
| Patients (%) achieving HbA1c <7% | 79 | 82 | 86 | 86 |
| Fasting Serum Glucose (mg/dL) | ||||
| Baseline (mean) | 171 | 174 | 174 | 172 |
| Change at Week 40 | -49 | -55 | -59 | -60 |
| Body Weight (kg) | ||||
| Baseline (mean) | 93.7 | 92.5 | 94.8 | 93.8 |
| Change at Week 40 | -5.7 | -7.6 | -9.3 | -11.2 |
| Difference from semaglutide (95% CI) | -- | -1.9 (-2.8, -1.0) | -3.6 (-4.5, -2.7) | -5.5 (-6.4, -4.6) |
a The modified intent-to-treat population consists of all randomly assigned participants who were exposed to at least 1 dose of study drug. Patients who discontinued study treatment because they did not meet study enrollment criteria were excluded. During the trial, rescue medication (additional antihyperglycemic medication) was initiated by 3%, 2%, 1%, and 1% of patients randomized to semaglutide 1 mg, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. At Week 40 the HbA1c endpoint was missing for 5%, 4%, 5%, and 5% of patients randomized to semaglutide 1 mg, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. Missing Week 40 data were imputed using multiple imputation with retrieved dropout.
b Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
c p<0.05 (two-sided) for superiority versus semaglutide, adjusted for multiplicity.
d p<0.001 (two-sided) for superiority versus semaglutide, adjusted for multiplicity.
e Analyzed using logistic regression adjusted for baseline value and other stratification factors.
f p<0.01 (two-sided) for superiority versus semaglutide, adjusted for multiplicity.
Figure 2: Mean HbA1c (%) Over Time - Baseline to Week 40
| Number of patients | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MOUNJARO 5mg | 470 | 451 | 470 | |||||||||
| MOUNJARO 10mg | 469 | 445 | 469 | |||||||||
| MOUNJARO 15mg | 469 | 447 | 469 | |||||||||
| Semaglutide 1mg | 468 | 443 | 468 |
Note: Displayed results are from modified Intent-to-Treat Full Analysis Set. (1) Observed mean value from Week 0 to Week 40, and (2) least-squares mean ± standard error at Week 40 multiple imputation (MI).
Add-on to metformin with or without SGLT2 inhibitor
SURPASS-3 (NCT03882970) was a 52-week open-label trial that randomized 1,444 adult patients with type 2 diabetes mellitus with inadequate glycemic control on stable doses of metformin with or without SGLT2 inhibitor to the addition of subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, MOUNJARO 15 mg once weekly, or insulin degludec 100 units/mL once daily. In this trial, 32% of patients were on SGLT2 inhibitor. Insulin degludec was initiated at 10 units once daily and adjusted weekly throughout the trial using a treat-to-target algorithm based on self-measured fasting blood glucose values. At Week 52, 26% of patients randomized to insulin degludec achieved the fasting serum glucose target of <90 mg/dL, and the mean daily insulin degludec dose was 49 U (0.5 U per kilogram).
Patients had a mean age of 57 years, and 56% were men. The mean duration of type 2 diabetes mellitus was 8.4 years, and the mean baseline BMI was 34 kg/m 2 . Overall, 91% were White, 3% were Black or African American, and 5% were Asian; 29% identified as Hispanic or Latino ethnicity.
Treatment with MOUNJARO 10 mg and 15 mg once weekly for 52 weeks resulted in a statistically significant reduction in HbA1c compared with daily insulin degludec (see Table 6 ).
| Insulin Degludec | MOUNJARO 5 mg | MOUNJARO 10 mg | MOUNJARO 15 mg | |
| Modified Intent-to-Treat (mITT) Population (N) | 359 | 358 | 360 | 358 |
| HbA1c (%) | ||||
| Baseline (mean) | 8.1 | 8.2 | 8.2 | 8.2 |
| Change at Week 52 | -1.3 | -1.9 | -2.0 | -2.1 |
| Difference from insulin degludec (95% CI) | -- | -0.6 (-0.7, -0.5) | -0.8 (-0.9, -0.6) | -0.9 (-1.0, -0.7) |
| Patients (%) achieving HbA1c <7% | 58 | 79 | 82 | 83 |
| Fasting Serum Glucose (mg/dL) | ||||
| Baseline (mean) | 167 | 172 | 170 | 168 |
| Change at Week 52 | -51 | -47 | -50 | -54 |
| Body Weight (kg) | ||||
| Baseline (mean) | 94.0 | 94.4 | 93.8 | 94.9 |
| Change at Week 52 | 1.9 | -7.0 | -9.6 | -11.3 |
| Difference from insulin degludec (95% CI) | -- | -8.9 (-10.0, -7.8) | -11.5 (-12.6, -10.4) | -13.2 (-14.3, -12.1) |
a The modified intent-to-treat population consists of all randomly assigned participants who were exposed to at least 1 dose of study drug. Patients who discontinued study treatment because they did not meet study enrollment criteria were excluded. During the trial, rescue medication (additional antihyperglycemic medication) was initiated by 1%,1%, 1%, and 2% of patients randomized to insulin degludec, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. At Week 52 the HbA1c endpoint was missing for 9%, 6%, 10%, and 5% of patients randomized to insulin degludec, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. Missing Week 52 data were imputed using multiple imputation with retrieved dropout.
b Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
c p<0.001 (two-sided) for superiority versus insulin degludec, adjusted for multiplicity.
d Analyzed using logistic regression adjusted for baseline value and other stratification factors.
Add-on to 1-3 oral anti-hyperglycemic agents (metformin, sulfonylurea, or SGLT-2 inhibitor)
SURPASS-4 (NCT03730662) was a 104-week open-label trial (52-week primary endpoint) that randomized 2002 adult patients with type 2 diabetes mellitus with increased CV risk to subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, MOUNJARO 15 mg once weekly, or insulin glargine 100 units/mL once daily (1:1:1:3 ratio) on a background of metformin (95%) and/or sulfonylureas (54%) and/or SGLT2 inhibitors (25%).
Patients had a mean age of 64 years, and 63% were men. The mean duration of type 2 diabetes mellitus was 11.8 years, and the mean baseline BMI was 33 kg/m 2 . Overall, 82% were White, 4% were Black or African American, and 4% were Asian; 48% identified as Hispanic or Latino ethnicity. Across all treatment groups, 87% had a history of CV disease. At baseline, eGFR was ≥90 mL/min/1.73 m 2 in 43%, 60 to 90 mL/min/1.73 m 2 in 40%, 45 to 60 mL/min/1.73 m 2 in 10%, and 30 to 45 mL/min/1.73 m 2 in 6% of patients.
Insulin glargine was initiated at 10 U once daily and adjusted weekly throughout the trial using a treat-to-target algorithm based on self-measured fasting blood glucose values. 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 per kilogram).
Treatment with MOUNJARO 10 mg and 15 mg once weekly for 52 weeks resulted in a statistically significant reduction in HbA1c compared with insulin glargine once daily (see Table 7 ).
| Insulin Glargine | MOUNJARO 5 mg | MOUNJARO 10 mg | MOUNJARO 15 mg | |
| Modified Intent-to-Treat (mITT) Population (N) | 998 | 328 | 326 | 337 |
| HbA1c (%) | ||||
| Baseline (mean) | 8.5 | 8.5 | 8.6 | 8.5 |
| Change at Week 52 | -1.4 | -2.1 | -2.3 | -2.4 |
| Difference from insulin glargine (95% CI) | -- | -0.7 (-0.9, -0.6) | -0.9 (-1.1, -0.8) | -1.0 (-1.2, -0.9) |
| Patients (%) achieving HbA1c <7% | 49 | 75 | 83 | 85 |
| Fasting Serum Glucose (mg/dL) | ||||
| Baseline (mean) | 168 | 172 | 176 | 174 |
| Change at Week 52 | -49 | -44 | -50 | -55 |
| Body Weight (kg) | ||||
| Baseline (mean) | 90.2 | 90.3 | 90.6 | 90.0 |
| Change at Week 52 | 1.7 | -6.4 | -8.9 | -10.6 |
| Difference from insulin glargine (95% CI) | -- | -8.1 (-8.9, -7.3) | -10.6 (-11.4, -9.8) | -12.2 (-13.0, -11.5) |
a The modified intent-to-treat population consists of all randomly assigned participants who were exposed to at least 1 dose of study drug. Patients who discontinued study treatment because they did not meet study enrollment criteria were excluded. During the trial, rescue medication (additional antihyperglycemic medication) was initiated by 1%, 0%, 0%, and 1% of patients randomized to insulin glargine, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. At Week 52 the HbA1c endpoint was missing for 9%, 9%, 6%, and 4% of patients randomized to insulin glargine, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. Missing Week 52 data were imputed using multiple imputation with retrieved dropout.
b Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
c p<0.001 (two-sided) for superiority versus insulin glargine, adjusted for multiplicity.
d Analyzed using logistic regression adjusted for baseline value and other stratification factors.
MOUNJARO Use in Combination with Basal Insulin with or without Metformin in Adult Patients with Type 2 Diabetes Mellitus
SURPASS-5 (NCT04039503) was a 40-week double-blind trial that randomized 475 adult patients with type 2 diabetes mellitus with inadequate glycemic control on insulin glargine 100 units/mL, with or without metformin, to subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, MOUNJARO 15 mg once weekly, or placebo. The dose of background insulin glargine was adjusted using a treat-to-target algorithm based on self-measured fasting blood glucose values, targeting <100 mg/dL.
Patients had a mean age of 61 years, and 56% were men. The mean duration of type 2 diabetes mellitus was 13.3 years, and the mean baseline BMI was 33 kg/m 2 . Overall, 80% were White, 1% were Black or African American, and 18% were Asian; 5% identified as Hispanic or Latino ethnicity.
The mean dose of insulin glargine at baseline was 34, 32, 35, and 33 units/day for patients receiving MOUNJARO 5 mg, 10 mg, 15 mg, and placebo, respectively. At randomization, the initial insulin glargine dose in patients with HbA1c ≤8.0% was reduced by 20%. At week 40, mean dose of insulin glargine was 38, 36, 29, and 59 units/day for patients receiving MOUNJARO 5 mg, 10 mg, 15 mg, and placebo, respectively.
Treatment with MOUNJARO 5 mg once weekly, 10 mg once weekly and 15 mg once weekly for 40 weeks resulted in a statistically significant reduction in HbA1c compared with placebo (see Table 8 ).
| Placebo | MOUNJARO 5 mg | MOUNJARO 10 mg | MOUNJARO 15 mg | |
| Modified Intent-to-Treat (mITT) Population (N) | 119 | 116 | 118 | 118 |
| HbA1c (%) | ||||
| Baseline (mean) | 8.4 | 8.3 | 8.4 | 8.2 |
| Change at Week 40 | -0.9 | -2.1 | -2.4 | -2.3 |
| Difference from placebo (95% CI) | -- | -1.2 (-1.5, -1.0) | -1.5 (-1.8, -1.3) | -1.5 (-1.7, -1.2) |
| Patients (%) achieving HbA1c <7% | 35 | 87 | 90 | 85 |
| Fasting Serum Glucose (mg/dL) | ||||
| Baseline (mean) | 164 | 163 | 163 | 160 |
| Change at Week 40 | -39 | -58 | -64 | -63 |
| Difference from placebo (95% CI) | -- | -19 (-27, -11) | -25 (-32, -17) | -23 (-31, -16) |
| Body Weight (kg) | ||||
| Baseline (mean) | 94.2 | 95.8 | 94.6 | 96.0 |
| Change at Week 40 | 1.6 | -5.4 | -7.5 | -8.8 |
| Difference from placebo (95% CI) | -- | -7.1 (-8.7, -5.4) | -9.1 (-10.7, -7.5) | -10.5 (-12.1, -8.8) |
a The modified intent-to-treat population consists of all randomly assigned participants who were exposed to at least 1 dose of study drug. Patients who discontinued study treatment because they did not meet study enrollment criteria were excluded. During the trial, rescue medication (additional antihyperglycemic medication) was initiated by 4%, 1%, 0%, and 1% of patients randomized to placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. At Week 40 the HbA1c endpoint was missing for 2%, 6%, 3%, and 7% of patients randomized to placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. Missing Week 40 data were imputed using placebo-based multiple imputation.
b Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
c p<0.001 (two-sided) for superiority versus placebo, adjusted for multiplicity.
d Analyzed using logistic regression adjusted for baseline value and other stratification factors.
MOUNJARO Use in Combination with Metformin or Basal Insulin, or Both in Pediatric Patients 10 Years of Age and Older with Type 2 Diabetes Mellitus
SURPASS-PEDS (NCT05260021) was a 30-week double-blind, placebo-controlled trial with a 22-week open-label extension that randomized 99 pediatric patients 10 years of age and older with type 2 diabetes mellitus with inadequate glycemic control on metformin (69%), or basal insulin (8%), or both (23%) to receive subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, or placebo once weekly as add-on therapy.
Patients had a mean age of 15 years, and 61% were female. The mean duration of type 2 diabetes mellitus was 2.4 years, mean HbA1c was 8.0%, mean weight was 97 kg, and the mean baseline BMI was 35 kg/m 2 . Overall, 58% were White, 11% were Black or African American, 6% were Asian, 20% were American Indian or Alaska Native, and 5% were other races; 66% identified as Hispanic or Latino ethnicity.
Treatment with MOUNJARO 5 mg once weekly and 10 mg once weekly for 30 weeks, both pooled and individually, resulted in a statistically significant reduction in HbA1c compared with placebo (see Table 9 ).
| Placebo | MOUNJARO 5 mg | MOUNJARO 10 mg | MOUNJARO 5 mg/10 mg pooled | |
| Modified Intent-to-Treat (mITT) Population (N) | 34 | 32 | 33 | 65 |
| HbA1c (%) | ||||
| Baseline (mean) | 8.0 | 8.2 | 7.9 | 8.1 |
| Change at Week 30 | -0.2 | -1.9 | -2.2 | -2.0 |
| Difference from placebo (95% CI) | -- | -1.7 (-2.4, -1.0) | -2.0 (-2.7, -1.3) | -1.8 (-2.4, -1.2) |
| Patients (%) with HbA1c ≤6.5% at Week 30 | 28 | 68 | 81 | 75 |
| Fasting Serum Glucose (mg/dL) | ||||
| Baseline (mean) | 156 | 148 | 152 | 150 |
| Change at Week 30 | -5 | -35 | -51 | -43 |
| Difference from placebo (95% CI) | -- | -30 (-53, -8) | -46 (-68, -24) | -38 (-57, -19) |
| BMI (kg/m) | ||||
| Baseline (mean) | 34.7 | 33.9 | 37.7 | 35.8 |
| Percent Change at Week 30 | -0.5 | -6.9 | -10.8 | -8.8 |
| Difference from placebo (%) (95% CI) | -- | -6.4 (-9.5, -3.2) | -10.3 (-13.5, -7.1) | -8.3 (-11.0, -5.6) |
a The modified intent-to-treat population consists of all randomly assigned participants who were exposed to at least 1 dose of study drug. During the trial, rescue medication (additional antihyperglycemic medication) was initiated by 6%, 0%, and 0% of patients randomized to placebo, MOUNJARO 5 mg, and 10 mg, respectively. At Week 30 the HbA1c endpoint was missing for 6%, 9%, and 18% of patients randomized to placebo, MOUNJARO 5 mg, and 10 mg, respectively. Missing Week 30 data were imputed using multiple imputation with placebo wash-out or with assumption of missing at random.
b Least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
c p<0.001 (two-sided) for superiority versus placebo, adjusted for multiplicity.
d Response in (%) is calculated by combining proportion of participants achieving target in imputed datasets using Rubin's rule.
e p<0.01 (two-sided) for superiority versus placebo, adjusted for multiplicity.
f Any missing values at baseline were imputed as missing at random.
Cardiovascular Outcomes Trial of MOUNJARO in Adults with Type 2 Diabetes Mellitus and Established Cardiovascular Disease
SURPASS-CVOT (NCT04255433) was a Phase 3, event-driven, multicenter, international, randomized, double-blind, active comparator controlled, parallel-group study. In this trial, 13,299 patients with inadequately controlled type 2 diabetes mellitus and established CV disease were randomized to once weekly subcutaneous MOUNJARO (up to 15 mg) versus once weekly subcutaneous dulaglutide (1.5 mg), a GLP-1 receptor agonist indicated for glycemic control and to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes mellitus who have established CV disease or multiple CV risk factors. MOUNJARO was initiated at a dosage of 2.5 mg once weekly and increased by 2.5 mg every 4 weeks to a maximum dosage of 15 mg once weekly or the maximum tolerated dose. The dose of dulaglutide was initiated and maintained at 1.5 mg once weekly. The primary endpoint was the time to first occurrence of a three-part composite MACE outcome of CV death, MI, or stroke (MACE-3).
Patients eligible to enroll in the trial had type 2 diabetes mellitus and established CV disease, were 40 years of age or older, had a HbA1c of ≥7.0% and ≤10.5%, and a BMI ≥ 25 kg/m 2 . The mean age was 64 years, the mean duration of type 2 diabetes mellitus was 15 years, the mean HbA1c concentration was 8.4%, and the mean BMI was 33 kg/m 2 . Overall, 71% of patients enrolled were male; 82% were White, 2% were Black or African American, and 9% were Asian; 30% identified Hispanic or Latino ethnicity.
Patients reported the following types of CV disease at baseline: coronary artery disease (65%); prior coronary revascularization (57%); prior MI (47%); peripheral arterial disease (25%); prior lower extremity arterial revascularization (6%); prior stroke (19%); prior carotid revascularization (3%); and prior heart failure (20%). Of patients enrolled in the study, 20% had diabetic neuropathy, 2% had proliferative diabetic retinopathy, and 29% had non-proliferative diabetic retinopathy. The percentage of patients with an eGFR < 60 mL/min/1.73 m 2 was 23%.
The most common antihyperglycemic medications taken at baseline were: metformin (81%), sodium-glucose cotransporter-2 (SGLT-2) inhibitors (31%), sulfonylureas (22%), and insulins (49%). At baseline CV disease and CV risk factors were managed with: statins (86%), antiplatelet therapies (83%), beta blockers (65%), angiotensin-converting enzyme (ACE) inhibitors (40%), and angiotensin receptor blockers (40%). During the trial, investigators were to modify anti-hyperglycemic and CV medications to achieve local standard of care treatment targets with respect to blood glucose, lipids, and blood pressure.
Over a median follow-up of 210.1 weeks, MOUNJARO was non-inferior to dulaglutide for reducing the occurrence of MACE-3. The estimated hazard ratio for time to first MACE was 0.92 (95.3% CI: 0.83, 1.01) for MOUNJARO compared to dulaglutide. Superiority to dulaglutide was not established. In this trial, 98% of participants had a complete assessment for the primary endpoint and 99.7% had vital status established. Refer to Figure 3 and Table 10 .
Figure 3: Kaplan-Meier Curve: Time to First Occurrence of a MACE-3 (CV death, non-fatal MI, or non-fatal stroke) in the SURPASS-CVOT Trial
| Dulaglutide N=6,647 (%) | MOUNJARO N=6,647 (%) | Hazard ratio vs Dulaglutide (95% CI) | |
| MACE-3 (Composite of time to first occurrence of CV death, non-fatal MI, or non-fatal stroke) | 863 (13.0) | 803 (12.1) | 0.92 (0.83, 1.01) |
| CV Death | 409 (6.2) | 367 (5.5) | 0.89 (0.77, 1.02) |
| Non-Fatal MI | 310 (4.7) | 292 (4.4) | 0.93 (0.80, 1.09) |
| Non-Fatal Stroke | 221 (3.3) | 215 (3.2) | 0.97 (0.80, 1.16) |
| Fatal or Non-Fatal MI | 358 (5.4) | 313 (4.7) | 0.87 (0.74, 1.01) |
| Fatal or Non-Fatal Stroke | 249 (3.7) | 229 (3.4) | 0.91 (0.76, 1.09) |
| All-Cause Death | 670 (10.1) | 567 (8.5) | 0.84 (0.75, 0.94) |
a 95.3% confidence interval for the MACE-3 composite endpoint of CV death, non-fatal MI, or non-fatal stroke
b Cox-proportional hazards models with treatment as a factor and stratified for SGLT2i use.
c p=0.007 for noninferiority of MOUNJARO to dulaglutide
d Not controlled for family-wise type I error rate
Reductions from baseline in HbA1c and body weight were observed with MOUNJARO and dulaglutide treatment at Month 36.
Source: Mounjaro prescribing information (FDA label on DailyMed), revised 2026-08-27
Mounjaro results: common questions
How much weight can you lose on Mounjaro?
In SURMOUNT-1, people on 15 mg weekly (Zepbound) had a mean weight change of -20.9% at 72 wks. That is an average across a trial, not a prediction for one person, and it depends on the dose reached and how long treatment continued.
How long does Mounjaro take to work?
The dose steps up first. On the schedule in its FDA label: 5 mg from week 5 if needed, up to 15 mg from week 21. Weight trials then measure results at a year or more. How long each GLP-1 takes, week by week
How long does Mounjaro stay in your system?
Mounjaro's FDA label gives a half-life of approximately 5 days and no figure for how long it stays. By the usual rule of five half-lives, that is about 25 days, which is our arithmetic and not the label's.
Can Mounjaro stop working?
Weight loss on these medicines levels off rather than continuing for good. The clearest measure comes from tirzepatide's trials: among adherent people who lost at least 5%, half had plateaued by about 24 to 36 weeks, depending on starting BMI. Talk to your prescriber if weight comes back while you are still taking it. When weight loss reaches a plateau
Trial averages do not predict what one person will experience.