Are you intrigued by the potential of Tirzepatide (Mounjaro® and Zepbound), a rising star in the field of medical weight management? If you’re eager to revolutionize your approach and offer patients a comprehensive solution, you’re about to delve into the right resource. Welcome to a world of insights that could reshape your medical practice – a comprehensive Tirzepatide (Mounjaro® and Zepbound) protocol for medical weight loss. In this article, we unravel the science behind this groundbreaking protocol, arming you with knowledge that might redefine your strategy and amplify patient success. If you’re ready to explore the potential of Tirzepatide (Mounjaro® and Zepbound) as a powerful tool for weight loss, this read is your guide.
I. Introduction to Tirzepatide as a Medical Weight Loss Treatment Option
Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, represents an emerging treatment option in the management of type 2 diabetes mellitus and obesity.
According to the article published by Frias et al. in The Lancet (2021), tirzepatide has shown significant reductions in HbA1c levels and body weight in individuals with type 2 diabetes compared with placebo or insulin glargine. Its unique action of simultaneously stimulating both GIP and GLP-1 receptors enhances glucose-dependent insulin secretion, reduces glucagon secretion, and slows gastric emptying, ultimately resulting in significant weight loss and better glycemic control.
Further, Coskun et al. (2020) in Cell Metabolism explained the superior weight loss effects of tirzepatide could be attributed to its ability to induce satiety, reduce food intake and possibly increase energy expenditure].
Clinical trials have also shown promising safety profiles of tirzepatide. The most common side effects are gastrointestinal, primarily nausea and diarrhea, and are usually mild and transient.
Overall, the preliminary results related to tirzepatide suggest its potential to become a new cornerstone in the therapeutic algorithm for obesity and diabetes management. However, further research and long-term studies are needed to elucidate the full extent of its clinical benefits and safety.
Understanding Glucagon & GLP-1
Glucagon and glucagon-like peptide-1 (GLP-1) are two peptide hormones that regulate glucose homeostasis.
Glucagon, a 29-amino-acid hormone, is secreted by the alpha cells of the pancreatic islets in response to low blood glucose levels. It raises blood glucose levels by stimulating glycogenolysis and gluconeogenesis in the liver. Also, glucagon promotes lipolysis in adipose tissue, providing free fatty acids as an alternative energy source during periods of low glucose availability. Since insulin promotes glucose uptake and storage, glucagon is a counter-regulatory hormone.
GLP-1, a 30-amino-acid hormone, is secreted by the L-cells of the gastrointestinal tract in response to food intake. GLP-1 helps in glucose homeostasis by enhancing glucose-dependent insulin secretion from the pancreatic beta cells, inhibiting glucagon secretion, and delaying gastric emptying. These actions result in reduced postprandial glycemia and improved overall glycemic control. GLP-1 also has central effects on the regulation of appetite and body weight, as it acts on the hypothalamus to promote satiety and reduce food intake.
FDA approval and indications
Tirzepatide was first approved by the FDA in May 2022 as Mounjaro, a once-weekly injectable medication for the treatment of adults with type 2 diabetes. The approval was based on data from nine clinical trials involving 7,769 patients with type 2 diabetes. In these trials, Mounjaro was shown to be more effective than other diabetes therapies at improving blood sugar control.
In addition to its effectiveness in treating diabetes, Mounjaro has also been shown to be effective for weight loss. In the SURMOUNT-1 trial, patients who received Mounjaro at a dose of 15 mg lost an average of 22.5% of their body weight over a period of 68 weeks. This was significantly more weight loss than was seen in patients who received placebo or other diabetes therapies.
2017: Eli Lilly and Company begins clinical trials of tirzepatide for the treatment of type 2 diabetes.
2022: The FDA approves tirzepatide as Mounjaro for the treatment of type 2 diabetes.
2023: The FDA approved tirzepatide as Zepbound for the treatment for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obesity) or
- 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).
II. Understanding Tirzepatide
Mechanism of action
Tirzepatide, as a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, exerts its effects by interacting with both these incretin hormone receptors, exhibiting a broad range of physiological actions beneficial for glucose homeostasis and weight loss.
According to the study published by Coskun et al. in Cell Metabolism (2020), tirzepatide’s dual agonist action enhances glucose-dependent insulin secretion from pancreatic beta cells, reduces glucagon secretion from alpha cells, and slows gastric emptying. These actions collectively contribute to improved glycemic control.
Additionally, by activating GLP-1 and GIP receptors in the brain, it promotes satiety and reduces food intake, which in combination with the slowed gastric emptying, leads to weight loss.
Interestingly, tirzepatide might also enhance energy expenditure, contributing to its weight-lowering effects, although the exact mechanism of this action is still not fully understood.
In summary, the mechanism of action of tirzepatide is multifaceted, operating through both glycemic and non-glycemic pathways to improve blood glucose levels and reduce body weight, positioning it as a promising therapeutic agent in managing type 2 diabetes and obesity.
Clinical trial outcomes and safety profile
Tirzepatide’s clinical efficacy and safety profile are largely established through the results from the SURPASS clinical trial program.
Frias et al. in The Lancet (2021) reported results from the SURPASS-2 trial that showed tirzepatide to be significantly superior in reducing HbA1c levels and body weight in patients with type 2 diabetes inadequately controlled with metformin, compared to a group treated with insulin glargine. They found mean HbA1c reductions from baseline of up to 2.46% and mean weight reductions of up to 13.1 kg with the highest dose of tirzepatide.
In another phase 3 trial, SURPASS-3, published by Rosenstock et al. in The New England Journal of Medicine (2021), tirzepatide was compared to insulin in patients with type 2 diabetes inadequately controlled with metformin, with or without SGLT2 inhibitors. The results showed superior reductions in HbA1c and body weight with tirzepatide.
CONTRAINDICATIONS
According to the package insert, Mounjaro® and Zepbound is contraindicated in patients with the following:
personal or family history of Medullary Thyroid Carcinoma
patients with Multiple Endocrine Neoplasm type 2
patients with a prior serious hypersensitivity reaction to tirzepatide or to any of the excipients in Mounjaro®and Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with Mounjaro® and Zepbound.
LIMITATIONS OF USE
According to the package insert, Mounjaro® and Zepbound has not been studied in patient with a history of pancreatitis. Also, it is not indicated for use in type 1 Diabetes.
WARNINGS AND PRECAUTIONS
The safety profile of tirzepatide in the treatment of obesity has been investigated through several clinical trials. Here are the top warnings based on its clinical trial:
Risk of ThyroidTumors: Patient’s initial work up and maintanence physical exam should include the thyroid exam and neck imaging.
Acute Pancreatitis: Patients should be monitored for signs and symptoms of acute pancreatitis.
Acute Gallbladder Disease: Patients should be monitored for signs and symptoms of acute gallbladder disease.
Hypoglycemia: There is an increased risk of hypoglycemia in patients who take tirzepatide with other hypoglycemic medication, such as sulfonylurea or insulin. Patients should be warned of the risk of hypoglycemia and blood glucose should be monitored in diabetic patients.
Acute Kidney Injury: Patients have experienced acute kidney injury or worsening renal failure requiring dialysis. Renal function should be monitored when initiating or escalating doses of tirzepatide.
Hypersensitivity Reactions: Anaphylaxis or angioedema has been reported in clinical trials. Patients with a history of hypersensitivity reaction to other GLP-1 receptor agonist should not be started on tirzepatide.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Temporary worsening of diabetic retinopathy has been associated with rapid improvement in glucose control.
ADVERSE EVENTS
According to clinical studies, gastrointestinal adverse events are the most common and tend to be mild to moderate, decreasing over time.
The most common adverse events reported in more than 5% of the patients treated with tirzepatide include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia and abdominal pain.
III. Tirzepatide Protocol Implementation
Starting dose and titration schedule
Mounjaro is the FDA approved tirzepatide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The dosage and strength include the following. 2.5 mg, 5 milligrams, 7.5 mg, 10 mg. 12.5 mg, or 15 mgper 0.5 ML in a single dose pen.
The recommended starting dose is 2.5 milligrams injected subcutaneously once a week. After four week, you can increase to 5 milligrams subcutaneous once weekly. If additional weight loss control was needed, then you increase the dose in 2.5 milligrams increments, after at least four weeks of the current dosage use.
The maximum dosage is 15 milligrams subcutaneous once weekly. You are to administer once weekly at any time of the day with or without meals. You inject subcutaneously in the abdomen thigh or the upper arm rotating the injection site with each dose
If a dose is missed, it should be administered as soon as possible, wiithin four days after the missed dose. If more than four days have passed, the missed dose should be skipped. And the next dose should be administered on the regularly scheduled day.
Monitoring patient progress and side effects
The American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) guidelines recommend that patients receiving treatments for obesity be evaluated every 4-12 weeks. During the first few months of the treatment when dosing titration occurs, it is essential to maintain close monitoring for side effects. Once the patient has reached the maintanence dose, follow up appointments can be scheduled according to the needs of the patient and the physician’s discretion. More frequent follow ups may be required if the patient is experiencing side effects.
Use in Pregnancy
Tirzepatide has not been testing in pregnant women. Discontinue tirzepatide when the patient is pregnant.
HOW TO INCORPORATE TIRZEPATIDE INTO YOUR MEDICAL WEIGHT LOSS PRACTICE?
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- Management of Obesity
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- Business Models
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BONUS
Medical Weight Loss Certification Training Manual
Semaglutide Protocol for Effective Medical Weight Loss
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