Library / Weight and metabolic
Tirzepatide
Also known as Mounjaro, Zepbound
Approved medicine
Dual GIP and GLP-1 receptor agonist peptide given by weekly injection. Approved for type 2 diabetes and for chronic weight management.
Prescription medicine. Only a prescriber can decide whether a medicine suits you and at what dose. This page is information, not a recommendation.
Background
Synthetic 39 amino acid peptide developed by Eli Lilly, built on the sequence of the gut hormone GIP with added GLP-1 activity and a fatty acid chain for once weekly dosing. FDA approved it as Mounjaro for type 2 diabetes in 2022 and as Zepbound for weight management in 2023.
How it is thought to work
Activates both GIP and GLP-1 receptors. This increases insulin release when glucose is high, lowers glucagon, slows stomach emptying and reduces appetite.
What is claimed, and the evidence
| Claim | Evidence | Notes |
|---|---|---|
| Improves blood sugar control in type 2 diabetes (adults and children 10 and over) | Approved use | Mounjaro label. |
| Chronic weight management in adults with obesity, or overweight with a weight related condition | Approved use | Zepbound label. SURMOUNT-1: mean weight change of minus 15% to minus 21% at 72 weeks versus minus 3% on placebo. |
| Treats moderate to severe obstructive sleep apnoea in adults with obesity | Approved use | Zepbound label. |
| Reduces major cardiovascular events in type 2 diabetes at high cardiovascular risk | Approved use | Current Mounjaro label. |
| 'Research' or compounded tirzepatide is equivalent to the approved medicine | No published evidence | FDA warns such products are of unknown quality; compounding of GLP-1 medicines is banned in Australia since 1 October 2024. |
Side effects
| Effect | How often | Notes |
|---|---|---|
| Nausea | Common | Most common on the label; mainly during dose increases. |
| Diarrhoea, vomiting, constipation, indigestion and abdominal pain | Common | Label lists these at 5% or more. |
| Decreased appetite | Common | Label. |
| Gallbladder disease Serious | Uncommon | Label warning. |
| Acute pancreatitis Serious | Rare | Label warning. |
| Low blood sugar with insulin or sulfonylureas Serious | Common | Label warning. |
| Acute kidney injury from dehydration Serious | Rare | Label warning. |
| Serious allergic reactions including anaphylaxis and angioedema Serious | Rare | Label warning. |
| Worsening diabetic eye disease Serious | Uncommon | Label warning in people with existing retinopathy. |
| Aspiration during anaesthesia or sedation Serious | Rare | Label warning. |
Warnings
- Boxed warning: causes thyroid C-cell tumours in rats; human relevance unknown. Not for people with a personal or family history of medullary thyroid cancer or MEN 2.
- Can cause pancreatitis, gallbladder disease and kidney injury from dehydration; not recommended with severe gastroparesis.
- Tell the treating team before surgery or sedation because of aspiration risk.
- FDA has warned about dosing errors with compounded tirzepatide and illegal online 'research' products; pharmacy compounded GLP-1 products are not permitted in Australia.
Phase 3 trials
SURMOUNT-5
Phase 3b, Completed, published. 751 participants, 72 weeks, open label. NCT05822830
- Population
- Adults with obesity without type 2 diabetes.
- Arms
- Tirzepatide up to 10 or 15 mg weekly, starting at 2.5 mg and stepping up every 4 weeks; Semaglutide up to 1.7 or 2.4 mg weekly
- Primary outcome
- Percentage change in body weight at week 72.
- Results
- Body weight changed by minus 20.2% on tirzepatide against minus 13.7% on semaglutide.
- Safety
- Gastrointestinal effects were the most common, mostly during dose escalation. Treatment discontinuation for adverse events is not given in the abstract.
- Source
- Aronne LJ et al. N Engl J Med 2025;393:26-36.
Doses in these trials were given under medical supervision.
Regulatory status
- Australia
- Approved (ARTG, Mounjaro). Schedule 4. Pharmacy compounding of GLP-1 receptor agonists has been prohibited since 1 October 2024.
- United States
- FDA approved (Mounjaro 2022 for type 2 diabetes; Zepbound 2023 for chronic weight management and obstructive sleep apnoea with obesity). Removed from the FDA drug shortage list in December 2024.
Sources
- DailyMed: Mounjaro (tirzepatide) prescribing information
- DailyMed: Zepbound (tirzepatide) prescribing information
- Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1)
- FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss
- TGA: Update on GLP-1 receptor agonist pharmacy compounding changes
- TGA ARTG search: tirzepatide
- Drugs@FDA: Mounjaro (tirzepatide)
Also in Weight and metabolic
From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Tirzepatide.