Tirzepatide

(Mounjaro®)

Mounjaro®

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen)
Drug ClassGlucose-dependent insulinotropic polypeptides (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Latest News

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Summary
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  • Mounjaro (tirzepatide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
  • HbA1c Reduction: Tirzepatide 15 mg showed the most significant HbA1c reduction compared to subcutaneous semaglutide 1.0 mg and oral semaglutide 14 mg. It also demonstrated superior HbA1c reduction compared to basal insulin, GLP-1RAs, and placebo, with higher doses (10 mg and 15 mg) being more effective.
  • Body Weight Reduction: Tirzepatide 15 mg was most effective in reducing body weight compared to semaglutide and other comparators. Higher doses (10 mg and 15 mg) showed more significant weight reduction compared to lower doses and other agents.
  • Fasting Plasma Glucose: Tirzepatide effectively lowered fasting plasma glucose levels compared to basal insulin and GLP-1RAs.
  • HbA1c Target Achievement: A higher proportion of patients achieved HbA1c targets with tirzepatide compared to other glucose-lowering agents.
  • Gastrointestinal Adverse Events: Higher incidence of nausea, vomiting, diarrhea, decreased appetite, dyspepsia, and constipation was observed with tirzepatide, with more frequent and severe events at higher doses (10 mg and 15 mg) compared to placebo and other glucose-lowering agents.
  • Hypoglycemia and Cardiovascular Safety: Tirzepatide did not significantly increase the incidence of hypoglycemia compared to placebo, basal insulin, or GLP-1RAs, and there was no significant increase in serious cardiovascular events or mortality.
  • Discontinuation and Injection-Site Reactions: Higher doses (10 mg and 15 mg) of tirzepatide were associated with higher discontinuation rates due to adverse events and more frequent injection-site reactions. Additionally, an increased risk of gallbladder or biliary diseases was noted, though not for pancreatitis.
  • Tirzepatide demonstrated significant effectiveness in reducing HbA1c levels and inducing weight loss among Japanese patients with type 2 diabetes, with consistent efficacy observed across the general type 2 diabetes population when compared to various glucose-lowering agents; however, higher doses required specific attention due to increased rates of gastrointestinal adverse events and discontinuation.

Product Monograph / Prescribing Information

Document TitleYearSource
Mounjaro (tirzepatide) Prescribing Information.2023Lilly USA LLC, Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effect of tirzepatide on glycaemic control and weight loss compared with other glucagon-like peptide-1 receptor agonists in Japanese patients with type 2 diabetes mellitus.2024Diabetes, Obesity & Metabolism
Evaluation and comparison of efficacy and safety of tirzepatide and semaglutide in patients with type 2 diabetes mellitus: A Bayesian network meta-analysis2024Pharmacological Research
Meta-analysis of head-to-head clinical trials comparing incretin-based glucose-lowering medications and basal insulin: An update including recently developed glucagon-like peptide-1 (GLP-1) receptor agonists and the glucose-dependent insulinotropic polypeptide/GLP-1 receptor co-agonist tirzepatide.2023Diabetes Obesity and Metabolism
A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable?2023Frontiers in Endocrinology
Tirzepatide-induced gastrointestinal manifestations: A systematic review and meta-analysis. 2023Cureus
Safety issues of tirzepatide (pancreatitis and gallbladder or biliary disease) in type 2 diabetes and obesity: A systematic review and meta-analysis. 2023Frontiers in Endocrinology
Efficacy and safety of tirzepatide, dual GLP-1/GIP receptor agonists, in the management of type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. 2023Diabetology & metabolic syndrome
Glucometabolic outcomes of GLP-1 receptor agonist-based therapies in patients with type 2 diabetes: A systematic review and network meta-analysis. 2023EClinical Medicine
Impact of a dual glucose-dependent insulinotropic peptide/glucagon-like peptide-1 receptor agonist tirzepatide on heart rate among patients with type 2 diabetes: A systematic review and pairwise and network meta-analysis. 2023Diabetes, Obesity & Metabolism
Semaglutide for the treatment of type 2 diabetes mellitus: A systematic review and network meta-analysis of safety and efficacy outcomes.2022Diabetes & Metabolic Syndrome: Clinical Research & Reviews
Efficacy and safety of tirzepatide in patients with type 2 diabetes mellitus: A Bayesian network meta-analysis. 2022Frontiers in Pharmacology
Semaglutide for the treatment of type 2 diabetes mellitus: A systematic review and network meta-analysis of safety and efficacy outcomes.2022Diabetes & Metabolic Syndrome: Clinical Research & Reviews
Efficacy and safety of tirzepatide as novel treatment for type 2 diabetes: A systematic review and meta-analysis of randomized clinical trials. 2022Diabetes & Metabolic Syndrome: Clinical Research & Reviews
Optimal dose of tirzepatide for type 2 diabetes mellitus: A meta-analysis and trial sequential analysis.2022Frontiers in Cardiovascular Medicine
Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: A systematic review and meta-analysis.2022Diabetologia
Efficacy and safety of tirzepatide in patients with type 2 diabetes: A systematic review and meta-analysis.2022Frontiers in Pharmacology
Efficacy and safety of tirzepatide in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized phase II/III trials.2021Pharmaceuticals