Drug updated on 11/5/2024
| Dosage Form | Injection (subcutaneous; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL) |
| Drug Class | Glucagon-like peptide 1 (GLP-1) receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity)
- Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).
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Summary
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- Weight Loss: Tirzepatide significantly reduced body weight, BMI, and waist circumference compared to placebo, GLP-1 receptor agonists (GLP-1 RAs), and insulin. Weight loss was dose-dependent, with mean differences in body weight percentage change ranging from -8.07% to -11.83%, and absolute weight loss ranging from -7.5 kg to -11.5 kg, depending on the dose.
- Glycaemic Control: Tirzepatide led to significant reductions in HbA1c and fasting serum glucose (FSG) levels compared to placebo and other antihyperglycaemic drugs, demonstrating its efficacy in improving glycaemic outcomes.
- Metabolic Markers: Tirzepatide improved various metabolic markers, including reductions in blood pressure, triglycerides, and increases in HDL cholesterol. It also showed improvements in fasting blood glucose and lipid profiles, particularly in higher dose groups.
- Cardiovascular Outcomes: Tirzepatide showed no significant increase in the risk of major cardiovascular events (MACE-4) compared to controls, with potential advantages in reducing cardiovascular outcomes among GLP-1 RAs.
- Tirzepatide was associated with higher risks of nausea (Odds Ratio (OR) 4.26), vomiting (OR 8.35), and diarrhea (OR 3.57) compared to placebo.
- Gastrointestinal side effects were the most frequently reported, generally mild-to-moderate and transient.
- No significant increase in the risk of pancreatitis but a noted increase in composite gallbladder or biliary diseases.
- The reviewed documents included overweight/obese adults with and without type 2 diabetes, with subgroup analyses showing stronger effects of tirzepatide at higher doses for weight loss and metabolic outcomes, as well as an increased risk of hypoglycemia and composite gallbladder or biliary diseases at higher doses.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zepbound (tirzepatide) Prescribing Information. | 2024 | Lilly USA, LLC., Indianapolis, IN |