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      Tirzepatide

      What is tirzepatide?

      Tirzepatide is a peptide medication that mimics the actions of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). GLP-1 is a hormone released by the intestines in response to food to aid in glucose metabolism and satiety (feeling full after a meal). GLP-1 decreases the rate at which food empties from the stomach, which reduces calorie intake and promotes weight loss.^1 The body clears GLP-1 made by the intestinal cells within minutes.^2 Tirzepatide is given as a weekly injection because it is slowly removed from the body.^3 


      GIP is another incretin hormone secreted by the intestines in response to nutrient intake. GIP is involved with insulin signaling, fat metabolism, and satiety. Tirzepatide is about five times more potent at mimicking GIP than GLP-1.^4


      How is tirzepatide different from Mounjaro?

      Mounjaro is a brand-name medication that contains tirzepatide. The FDA approved Mounjaro for the management of type 2 diabetes. Clinical studies revealed that patients with diabetes who took Mounjaro lost weight. Subsequent trials in overweight and obese adults demonstrated efficacy as a weight loss agent; however, FDA approval for weight loss is currently pending. The tirzepatide that Nimbus uses is compounded in a specialty pharmacy because tirzepatide is on the FDA shortage list. The FDA shortage list lists medications where demand exceeds the available supply. Compounding pharmacies can compound a therapeutically equivalent tirzepatide and distribute that to patients with a legitimate prescription.^5


      How effective is tirzepatide for weight loss?

      The SURMOUNT-1 trial was a 72-week study done in obese individuals without diabetes. Three doses were compared to placebo: 5 mg, 10 mg, and 15 mg. Weight loss was 15% of body weight with the 5 mg dose, 19.5% of body weight with the 10 mg dose, and 20.9% of body weight with the 15 mg dose compared to 3.1% with placebo.^6 The SURMOUNT-3 trial utilized a 12-week lifestyle intervention lead-in period followed by 72 weeks of tirzepatide or placebo. The tirzepatide group lost 26.6% of their body weight after 12 weeks of lifestyle intervention, followed by 72 weeks of treatment. ^7 However, participants in SURMOUNT-4 showed significant weight regain after stopping tirzepatide. After 36 weeks on the tirzepatide trial, participants lost 21.1% of their body weight. The participants randomized to placebo after that regained 14.8% of their body weight over the next 52 weeks. For this reason, we do not believe in treating with tirzepatide alone. Our Nimbus Health Club has robust information regarding the big five of lifestyle medicine (mindset, nutrition, exercise, stress management, and sleep). These are essential to creating a mindset shift to ensure long-term behavioral changes and sustainable weight loss. 


      Who is not a good candidate for tirzepatide^8?

      Tirzepatide can interact with medications used for diabetes. Patients on diabetes medications other than metformin are at a higher risk of developing low blood sugars. Also, patients with diabetes complications of the eye should not use tirzepatide. Tirzepatide should not be used in patients with a history of pancreatitis, acute kidney injury, or gallbladder disease, as tirzepatide may worsen these conditions. Patients with a family or personal history of multiple endocrine neoplasia syndrome or medullary thyroid cancer are not candidates for tirzepatide therapy. Women who are pregnant or trying to become pregnant are not candidates for tirzepatide therapy. Patients with a history of gastroparesis or slowing of intestinal transit should be cautious when using GLP-1 medications, as tirzepatide may worsen these conditions.

      What are the adverse effects of tirzepatide?

      The most common adverse effects of tirzepatide are nausea, vomiting, abdominal pain and diarrhea. Serious adverse events leading to discontinuation of the medication were reported in 4.3% to 7.1% of participants in the SURMOUNT-1 trial. Serious adverse events were reported in 5.1% to 6.9% of participants. Seroius adverse events included pancreatitis, gallbladder and liver issues, allergic reactions, renal failure, and arrhythmias. 

      The gastrointestinal adverse effects of semaglutide are usually transient, mild, and resolve by the time the maintenance dose is reached. Persistent or severe nausea, vomiting, diarrhea, or abdominal pain is worrisome. Stop taking semaglutide if you experience persistent or severe nausea, vomiting, diarrhea, or abdominal pain, and seek immediate medical attention. Severe abdominal pain, nausea, or vomiting can be a sign of pancreatitis, which may require hospitalization for treatment. Do not “push through” repeated bouts of diarrhea, nausea, and vomiting, as this can lead to severe dehydration with serious consequences such as acute renal failure. Maintaining adequate hydration is essential for clinical success with semaglutide.

      Using GLP-1 medications without strength/resistance training and adequate protein intake can result in a significant loss of muscle mass. In two trials utilizing semaglutide, the participants saw 39% and 40% of their total weight loss be loss of muscle mass. ^9,10

      In September 2023, the FDA issued an alert for semaglutide (a GLP-1 medication like tirzepatide) due to reports of ileus (slowing or stopping flow through the intestines). This advisory is due to voluntary reports received by the FDA; however, at this time, the FDA can not estimate the frequency of ileus or whether the ileus was caused by semaglutide. Nimbus Healthcare will keep up with new information as it is released and update this page accordingly.


      Are there any tips to minimize tirzepatide adverse effects?

      To prevent muscle loss, we recommend maintaining a protein intake of approximately 0.8 g /lb of body weight and performing resistance training two to three times a week for a total of 75 minutes a week. We suggest working with a personal trainer or fitness professional to fine-tune your workout regimens to your individual needs.^11 As we age, sarcopenia (loss of muscle mass) is associated with an increased risk of cardiovascular disease, falls, dementia, diabetes, kidney dysfunction, some cancers, and poor disease prognosis. ^12

      Tirzepatide decreases the rate at which the stomach empties into the intestines, thus increasing satiety and fullness. Overeating can lead to nausea, vomiting, diarrhea, and abdominal pain. Tips to prevent overeating include eating slowly, eating smaller portions, limiting snacking and eating only when hungry, eating until you feel like you are 80% full, eating smaller, more frequent meals, avoiding using a straw to reduce swallowing air, limiting liquid intake during meals or 30 to 60 minutes before or after meals, limiting eating right before bed or eating and then lying down, and trying not to perform vigorous activity directly after a meal. Mint or ginger-based drinks and avoiding strong smells within 30 minutes of taking semaglutide may help to reduce nausea. 

      If an adverse effect persists at a specific dose but is not present at a lower dose, we recommend remaining at the lower dose. 

      Are there additional weight loss resources you recommend?

      I recommend the book Fat Loss Forever by Dr. Layne Norton. It is an excellent book on creating sustainable habits with nutrition and exercise to lose weight and keep it off. The Carbon Diet App is a great app that provides calorie counting and coaching. As you lose weight and gain muscle, your calorie needs will change. The Carbon Diet app offers guidance on calories and macros to maintain muscle mass while eating a diet below maintenance calories (a calorie deficit). Another good book on nutrition is Flexible Dieting by Alan Aragon. 

      How do I use tirzepatide?

      Tirzepatide is given as a subcutaneous (under the skin) injection once a week. Store tirzepatide in the refrigerator away from light, heat, and moisture. Unused or expired medication should be thrown away and not flushed down the toilet or placed down the sink. The starting dose is 2.5 mg per week, which is increased as tolerated every month until the maximum dose of 15 mg per week is achieved.

      How much medication to draw up in the syringe depends on your vial concentration and prescribed dose. See the instructions that come in your Nimbus package for accurate administration instructions.

       

      Citations

       1) Prasad-Reddy L, Isaacs D. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Drugs Context. 2015;4:212283. Published 2015 Jul 9. doi:10.7573/dic.212283

      2) Gupta V. Glucagon-like peptide-1 analogues: an overview. Indian J Endocrinol Metab. 2013;17(3):413–21.

      3) Mounjaro (tirzepatide) [prescribing information]. Indianapolis, IN: Eli Lilly; May 2022.

      4) Fisman, E.Z., Tenenbaum, A. The dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide: a novel cardiometabolic therapeutic prospect. Cardiovasc Diabetol 20, 225 (2021). https://doi.org/10.1186/s12933-021-01412-5

      5) https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

      6) Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038

      7) le Roux CW, Zhang S, Aronne LJ, et al. Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program. Obesity (Silver Spring). 2023;31(1):96-110. doi:10.1002/oby.23612

      8) Mounjaro (tirzepatide) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; May 2022.

      9) Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021;384(11):989-1002. doi:10.1056/NEJMoa2032183

      10) McCrimmon RJ, Catarig AM, Frias JP, et al. Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial. Diabetologia. 2020;63(3):473-485. doi:10.1007/s00125-019-05065-8

      11) Gorgojo-Martínez JJ, Mezquita-Raya P, Carretero-Gómez J, et al. Clinical Recommendations to Manage Gastrointestinal Adverse Events in Patients Treated with Glp-1 Receptor Agonists: A Multidisciplinary Expert Consensus. J Clin Med. 2022;12(1):145. Published 2022 Dec 24. doi:10.3390/jcm12010145

      12) He N, Zhang Y, Zhang L, Zhang S, Ye H. Relationship Between Sarcopenia and Cardiovascular Diseases in the Elderly: An Overview. Front Cardiovasc Med. 2021;8:743710. Published 2021 Dec 9. doi:10.3389/fcvm.2021.743710