WEIGHT
WEEKS
The only registered single agent for Chronic Weight Management that activates both GIP and GLP-1 receptors 1, 3
SURMOUNT-1 SURMOUNT-4 SURMOUNT-1 & 4
WEIGHT
Superior
-22.5 % body weight reduction vs placebo(– 2.4 %) 1 *
88
WEEKS
Significant
-26.0 % body weight reduction vs placebo(– 9.5 %) 4 ‡
Improved key cardiometabolic § parameters vs placebo 4, 5 ¶
62.9 %
Achieved ≥20 % body weight reduction vs placebo( 1.3 %) 1 †
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* Percentage body weight change from baseline to week 72 with Mounjaro 15 mg maintenance dose, p < 0.001;-20.1 % difference from placebo, p < 0.001, adjusted for multiplicity( mITT population). 1
† Percentage of participants achieving ≥20 % body weight reduction with Mounjaro 15 mg maintenance dose vs placebo, p < 0.001, adjusted for multiplicity. 1
‡ Additional secondary endpoint: p < 0.001 for percentage body weight change vs placebo for weeks 0 to 88, not adjusted for multiplicity. Efficacy estimand, MMRM analysis, data are LS means( treatment-regimen estimand =-25.3%, p < 0.001, data are observed mean values). 4 All primary and secondary endpoints met statistical significance, p < 0.001. 4
§
Mounjaro is not indicated to improve key cardiometabolic parameters, including waist circumference, blood pressure( systolic and diastolic), cholesterol( total, non-HDL, HDL, and LDL) and triglycerides. 1 Cardiometabolic parameters were secondary endpoints in SURMOUNT-1 and SURMOUNT-4. 4, 5
¶
SURMOUNT-1: Waist circumference: Mounjaro 5 mg, 10 mg and 15 mg vs placebo, p < 0.001( 5 mg not adjusted for multiplicity). 1 Triglycerides, HDL and non-HDL cholesterols, and systolic blood pressure: pooled Mounjaro groups vs placebo, p < 0.001; diastolic blood pressure and total and LDL cholesterols, p-values not reported. 5 Key secondary endpoints were adjusted for multiplicity. 5 SURMOUNT-4: systolic and diastolic blood pressure, triglycerides and LDL cholesterol, p < 0.001, Mounjaro MTD vs placebo, not adjusted for multiplicity; HDL cholesterol, p = 0.014, Mounjaro MTD vs placebo, not adjusted for multiplicity. 4
SURMOUNT-1 was powered to show superiority of Mounjaro( 10 mg, 15 mg, or both) to placebo with respect to the coprimary endpoints from baseline to week 72. 5
Studied in adults with obesity( BMI of ≥30 kg / m 2) or with overweight( BMI of ≥27 kg / m 2 to < 30 kg / m 2) with at least 1 weight-related complication, excluding type 2 diabetes. 1 All participants in SURMOUNT-1 and SURMOUNT-4 received lifestyle intervention, including a reduced-calorie diet and increased physical activity. 1, 4, 5
SURMOUNT-4 was a Phase 3 clinical trial with a 36-week lead-in period, in which all participants received Mounjaro maximum tolerated dose( 10 mg or 15 mg), and a 52-week double-blind period, in which participants were randomised to MTD or placebo. 4
Safety profile: Common adverse events with Mounjaro in SURMOUNT-1 and SURMOUNT-4 included nausea, diarrhoea, constipation and vomiting. 4, 5 These adverse events were mostly mild or moderate in severity, occurred more often during dose escalation, and decreased over time. 1, 4, 5
PBS Information: Mounjaro ®( tirzepatide) is not listed on the PBS.
Please refer to the full Product Information before prescribing. Product Information can be accessed at www. lilly. com. au / en / products, or by scanning the QR code, or on request by calling 1800 454 559.
This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www. tga. gov. au / reporting-problems.
© Eli Lilly Australia Pty Limited. Mounjaro ® is a registered trademark of Eli Lilly and Company. Eli Lilly Australia Pty Limited. ABN 39 000 233 992. Level 9, 60 Margaret St, Sydney NSW 2000. Telephone: 1800 454 559. Date of preparation: October 2024. PP-TR-AU-0430. 2007101.