Tirzepatide not only aids in appetite suppression but also improves insulin sensitivity, particularly in a person's fat tissue.
Published Jul 22, 2024 | 7:00 AM ⚊ Updated Jul 22, 2024 | 7:00 AM
Tirzepatide/Mounjaro injections. (Eli Lilly and Company)
Recently, the Central Drugs Standard Control Organisation’s (CDSCO) subject expert committee approved pharmaceutical giant Eli Lilly’s Tirzepatide — an active ingredient in their blockbuster drugs Mounjaro and Zepbound – known for its weight loss benefits.
However, the approval for it in India is specifically for diabetes treatment, not for weight loss, despite its known benefits in weight management.
Eli Lilly’s Tirzepatide has been approved by India’s drug regulator CDSCO for import and marketing in the country, allowing Indians to access this injectable ingredient for the first time.
Both drugs that use the ingredient, Mounjaro and Zepbound, will be available as pre-filled pens for subcutaneous injection. Eli Lilly is expected to launch Mounjaro in India as early as 2025, contingent upon the successful completion of regulatory reviews.
Earlier this year, Eli Lilly announced its expectation to introduce Mounjaro, its widely acclaimed diabetes and weight loss medication, in the Indian market as early as next year. Speaking to Reuters, CEO David Ricks had mentioned that this launch depends on the successful completion of an ongoing regulatory review process.
Imagine your body as a car, with food serving as the fuel that powers it. Just as a car transforms fuel into motion, your body converts food into energy. Here’s how tirzepatide helps optimize this process:
Insulin: This hormone acts like a helper, transporting sugar (fuel) from your food into your cells for energy. Tirzepatide boosts insulin production when you eat, effectively lowering your blood sugar levels.
Glucagon: This hormone raises blood sugar when your body needs extra energy. Tirzepatide reduces glucagon levels, preventing blood sugar from becoming too high.
Tirzepatide slows down the emptying of your stomach, allowing you to feel full for a long time after meals. This helps curb hunger and may lead to reduced food intake. Tirzepatide mimics two natural signals in your body: GLP-1 and GIP. These hormones help regulate blood sugar and appetite. By imitating their effects, tirzepatide enhances sugar utilisation and promotes satiety.
Tirzepatide is an innovative medication that mimics the natural hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) to effectively regulate appetite and blood sugar levels, promoting weight loss.
By acting on these hormones, tirzepatide enhances insulin secretion from the pancreas in response to meals, suppresses glucagon release (which raises blood sugar), and slows gastric emptying. This combination leads to a prolonged sensation of fullness and reduced food intake.
“We have other medicines, but tirzepatide is being introduced for the first time. We do have other weight loss drugs, and we actually prescribe them, and patients do lose a lot of weight. So it’s not like for the first time there is one medicine. This class of drug is called a dual GLP-1 and GIP analog. One of the major mechanisms for weight loss is that it reduces appetite. People don’t feel like eating, and specifically, the craving for junk food, like carbohydrate-rich and fat-rich food, comes down. I have patients who are on other other GLP-1 analogs available in India. There are three molecules in that class. Out of those, one is approved for weight loss. They all started as diabetes drugs, but they caused a lot of weight loss. For some of these molecules, they tested them in non-diabetic obese patients and got good results, leading to approval. In India, Victoza has been available for around seven years and causes a good amount of weight loss,” Consultant Endocrinologist at Yashoda Hospital in Hyderabad Dr. Vidya Tickoo texplained to South First.
The dual action of tirzepatide not only aids in appetite suppression but also improves insulin sensitivity, particularly in fat tissue, which can enhance fat metabolism. Clinical trials have demonstrated that patients using tirzepatide can achieve significant weight loss—averaging a reduction of 10 to 20 percent of body weight—making it a powerful tool for those struggling with obesity or type 2 diabetes.
Administered via subcutaneous injection once a week, tirzepatide is available in pre-filled pens for convenience. While it offers substantial benefits in weight management and blood sugar control, ongoing use may be necessary to maintain results, as discontinuation can lead to weight regain. Overall, tirzepatide represents a significant advancement in obesity treatment and metabolic health management.
Approval in India is based on global clinical trials, which included a significant number of Indian participants.
Tirzepatide has emerged as a significant advancement in weight management and diabetes control, demonstrating impressive efficacy in clinical trials. It functions as a dual incretin receptor agonist, targeting GLP-1 and GIP hormones, which play crucial roles in regulating appetite and blood sugar levels.
1. Adults with diabetes: In a trial focused on participants with type 2 diabetes, those treated with teriparatide experienced an average weight loss of 12 percent over the same duration. Specifically, participants lost up to 15.7 percentage of their body weight, equating to approximately 34.4 lbs (15.6 kg) for those on the higher dose.
2. SURMOUNT-1 Trial: This pivotal trial involved over 2,500 participants with obesity or overweight, revealing that tirzepatide led to a mean weight reduction of approximately 20% over 72 weeks. Notably, 36.2% of participants in the 15 mg group achieved a weight loss of 25% or more, showcasing its effectiveness compared to existing treatments.
3. Long-term effects: The SURMOUNT-4 trial assessed the long-term maintenance of weight loss. Participants who continued tirzepatide for an additional year lost an average of 5.5% more weight, while those on placebo regained about 14% of their lost weight, emphasising the necessity of ongoing treatment for sustained results.
“The advantage with tirzepatide is that it is more potent. In a study conducted on non-diabetic obese patients, it resulted in up to 20% weight loss, which is significant. For Indian patients, we find that using medications like Victoza typically leads to more than the expected weight loss. This isn’t a taboo topic anymore. Many patients have been asking for such medicines for a long time, especially in endocrinology where I work,” said Dr. Tickoo.
“I see this demand daily. Patients often inquire about these medications, especially since drugs like Ozempic have become popular in the US. People have friends there who have lost weight and ask if similar treatments are available in India. The sudden weight loss observed in their friends has made them aware of these options. The potential demand for tirzepatide is massive, and there is some uncertainty about meeting this demand when it launches in India,” Dr. Tickoo continued.
“In India, many people are obese or overweight, and the BMI criteria is lower compared to Western populations. For instance, a BMI of 23.5 is considered overweight here. Additionally, we have a condition called normal weight obesity, where the BMI might be normal but body fat is high, especially abdominal fat. This predisposes individuals to various diseases. Nowadays, awareness about obesity and its consequences has increased, partly due to social media. People know what obesity is and its potential health impacts,” explains the doctor.
She further sexplained, “lifestyle modifications like diet and exercise are always the first line of treatment. However, for patients who fail to achieve results through these methods, medications like tirzepatide can be very effective. These drugs can prevent complications associated with obesity, such as heart disease, diabetes, hypertension, and certain cancers. So, if a drug can help where lifestyle changes have failed, why not use it?”
Dr Tickoo said that in the Indian context, the problem with the drug is twofold. “First, they need to ensure they can meet the entire demand before introducing it. It shouldn’t happen that the drug is introduced and then there is a shortage, leaving many patients without it. So, I think thats why they are also taking time to introduce this in India,” told the doctor to South First.
She said that another problem is the cost. It is very costly, and not many people will be able to afford it monthly. “We don’t know the exact cost in India yet, but it will definitely be expensive. Additionally, with obesity drugs, there is no endpoint. You can’t take it for two years, stop, and expect everything to remain normal. These drugs must be continued to maintain benefits, or there is a risk of rebound weight gain. Some amount of weight might come back once the drug is stopped, even if it doesn’t return to the original level,” said Dr Tickoo.
She however pointed out that the long-term impact and cost-effectiveness are significant concerns. “While the drug might not be pocket-friendly, it could be cost-effective in the long run by preventing more expensive treatments like angioplasty or bypass surgery. For diabetics, who already need the medication, this drug could provide additional benefits,” she said.
Currently, we have other similar drugs like Trulicity (dulaglutide), Victoza (liraglutide), and Ozempic (semaglutide) available in India. “These drugs are approved for diabetic patients and have shown significant weight loss benefits, with some of my patients losing 10-15 kg,” concluded Dr. Tickoo.
Tirzepatide can cause a range of side effects, which can be categorised into common and serious reactions.
Common side effects
The most frequently reported side effects include:
– Nausea and Vomiting: These are among the most common reactions, particularly at the start of treatment or after dosage increases.
– Diarrhoea: A significant number of users experience diarrhea, which may lead to dehydration if it gets severe.
– Abdominal Pain and Bloating: Many users report discomfort or swelling in the abdominal area.
– Constipation: Some individuals may experience slower digestion, leading to constipation.
– Fatigue: Tiredness can occur, although it is less commonly reported.
– Injection Site Reactions: Redness, swelling, or itching may occur at the site of injection.
Serious Side Effects
While most side effects are manageable, some may require immediate medical attention:
– Pancreatitis: Symptoms include severe abdominal pain, nausea, and vomiting. Patients should seek emergency care if these occur.
– Allergic Reactions: Signs include hives, difficulty breathing, and swelling of the face or throat.
– Thyroid Tumours: There is a potential risk of thyroid C-cell tumors, particularly in individuals with a history of thyroid cancer or Multiple Endocrine Neoplasia (MEN) syndrome.
– Kidney Problems: Symptoms such as reduced urination, swelling in the legs, and fatigue may indicate kidney issues.
– Vision Changes: Blurred vision or other eye-related symptoms can occur, particularly in patients with diabetic retinopathy.
Patients should be monitored for symptoms of low blood sugar, such as sweating, dizziness, and confusion, especially if they are also on diabetes medications. It is advisable to consult a healthcare provider regarding any persistent or severe side effects.
“Like any new molecule, the long-term effects and side effects are unknown. We’ll only know about it after it has been on the market for 20, 30, or 50 years. For instance, the trial for tirzepatide lasted 72 weeks, and while some side effects like gallstones and pancreatitis were identified, long-term effects will only be evident with time,” said Dr Tickoo.
She said that when a new drug is introduced, there are several phases, with the last one being post-marketing surveillance. Even after a drug is deemed safe for market introduction, surveillance continues to monitor long-term effects. “Retrospective data analysis over decades helps identify any increase in particular diseases among those prescribed the medication. This data will only emerge with time,” explained Dr. Tickoo.
(Edited by Neena)
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