The newest weight loss med on the block is tirzepatide. As with any new drug, information about its benefits and risks can be hard to find. If you’re considering whether tirzepatide is right for you, you probably have lots of questions.
In this article, we’ll explore the most important clinical trials for tirzepatide so you can make an informed decision. We’ll look at how much weight different groups of people lost, how quickly it worked, potential side effects, and whether compounded tirzepatide is a good option for you.
SURMOUNT Trials
Over the past few years, the maker of tirzepatide (Eli Lilly) has conducted the SURMOUNT clinical trials to test tirzepatide's effectiveness as a weight loss medication. This group of four major trials, which wrapped up in 2023, aimed to evaluate tirzepatide in various populations struggling with obesity and excess weight. 1
In this section, we’ll discuss the results that emerged from three of the most interesting SURMOUNT trials.
SURMOUNT-1: Weight Loss Effectiveness in People without Type 2 Diabetes
The SURMOUNT-1 clinical trial set out to determine if tirzepatide could effectively and safely reduce body weight in adults without type 2 diabetes who were: 1
- Obese (BMI greater than 30)
OR
- Overweight (BMI greater than 27) with the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. 1
Participants from several countries were enrolled and then randomly assigned to receive either a placebo or one of three doses of tirzepatide (5 mg, 10 mg or 15 mg) in addition to making lifestyle changes like eating less and exercising more. 1
Participants in the tirzepatide groups started at 2.5 mg per week, gradually increasing the dose each month until reaching their target level. After 72 weeks, the results showed that tirzepatide led to significant weight loss compared to the placebo. 1
- Tirzepatide 5 mg: Participants experienced a body weight reduction of 15%.
- Tirzepatide 10 mg: Participants experienced body weight reductions of 19.5%
- Tirzepatide 15 mg: Participants experienced body weight reductions of 20.9%
- Placebo: Participants achieved body weight reductions of 3.1% 1
The results show that tirzepatide led to substantial reductions in body weight compared to the placebo, with higher doses of tirzepatide leading to even more significant weight loss.
SURMOUNT-2: Weight Loss Effectiveness in People with Type 2 Diabetes
In the 72-week SURMOUNT-2 trial, researchers wanted to see if tirzepatide could help overweight or obese adults with type 2 diabetes lose weight. They recruited participants from eight countries, including the United States, and randomly assigned them to one of three groups: 2
- Tirzepatide 10 mg
- Tirzepatide 15 mg
- Placebo 2
Participants in the tirzepatide groups started at 2.5 mg per week, gradually increasing the dose every month until reaching their assigned amount. 2
At the end of the 72 weeks, researchers found promising results:
- Tirzepatide 10 mg: Participants experienced body weight reductions of 12.8%
- Tirzepatide 15 mg: Participants experienced body weight reductions of 14.7%
- Placebo: Participants achieved body weight reductions of 3.2% 2
The results demonstrate that tirzepatide, at either dose, led to meaningful weight loss for people with type 2 diabetes. Interestingly, the weight loss was slightly less for this group compared to people without diabetes in the SURMOUNT-1 trial. While the reason for this is unclear, the effectiveness of tirzepatide in producing significant weight loss in both groups is substantial. 2
SURMOUNT-3: Weight Loss Effectiveness after Lifestyle Modifications
The SURMOUNT-3 trial took a different approach compared to the first two phases of the study. Before starting treatment with tirzepatide, participants first went through a 12-week intensive lifestyle intervention program. 3 This "boot camp" armed participants with new knowledge and skills, including:
- Learning about low-calorie diets and healthy food choices
- Starting exercise regimens and fitness plans
- Attending weekly counseling sessions 3
After this jumpstart, participants were ready to begin the 72-week treatment phase. The participants were overweight or obese adults from the U.S., Argentina, Brazil, and Puerto Rico. 3 They were randomly divided into three groups:
- Tirzepatide 10 mg
- Tirzepatide 15 mg
- Placebo 3
The results showed that the lifestyle intervention gave participants a head start on their weight loss journey.
- After completing the 12-week program, participants had already lost an average of 6.9% of their body weight.
- By the end of the 72-week treatment, tirzepatide patients lost an additional 21.1% of their body weight. Those receiving a placebo actually regained 3.3% of their weight. 3
This study shows that tirzepatide works best when paired with informed lifestyle and behavior changes. After the intensive training, participants lost more weight than in SURMOUNT-1, where they did not receive counseling and education. 1
How Quickly Does Tirzepatide Work for Weight Loss?
When you first start taking tirzepatide, don't expect to shed pounds overnight. In month one, your doctor will start you on a low dose to minimize side effects. You'll move up to a therapeutic dose over the next few months. The doses that typically lead to weight loss are 5 mg to 15 mg. Your doctor will gradually increase your dosage by 2.5 mg each month until you find your sweet spot. 4
Some people respond to lower doses, while others need more tirzepatide to see results. Work with your doctor to tailor your dosage to your body. The more time you spend at an effective dose, the more weight you’ll lose.
To accelerate your weight loss, pair tirzepatide with healthy habits. Eat nutritious foods, cut calories modestly, and stay active. Tirzepatide works with you, not for you. Combining the medication with lifestyle changes leads to the most weight loss. 4
In studies, people taking tirzepatide 10 mg for 72 weeks lost:
- 19.5% of their body weight (without diabetes) 1
- 12.8% of their body weight (with diabetes) 2
- 21.1% of their body weight with lifestyle counseling 3
Tirzepatide Safety
When it comes to weight loss, we all want to shed pounds safely. That's why clinical trials are so important - they help ensure new medications are effective and don't cause concerning side effects.
In clinical trials with over 2,500 participants, researchers evaluated tirzepatide's safety profile. They gave adults with obesity three different doses - 5 mg, 10 mg, or 15 mg taken once weekly - for 72 weeks. The results? Tirzepatide led to weight loss, but also some temporary tummy troubles. 4
The most common side effects were:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Indigestion 4
Generally, more people reported these issues at higher doses. The side effects also tended to pop up when first starting tirzepatide or after dose increases. 4
However, the good news is that for most people, the side effects were temporary. Over time, the body seemed to adjust to tirzepatide, and the side effects diminished or went away completely. 4
What is Compounded Tirzepatide?
Compounding is a specialized process where a pharmacist mixes ingredients to create a customized medication for an individual patient. Compounding pharmacies work directly with patients to determine the best treatment options based on their allergies and medical needs. 5
The main benefit of compounded tirzepatide is significant cost savings compared to expensive brand name drugs. Compounded drugs cut out the middlemen - avoiding the high marketing and branding costs built into most pharmaceuticals. 6
Conclusion
The introduction of a new medication can be both exciting and overwhelming. With tirzepatide hitting the market, it's only natural to have questions and concerns. However, it's important to keep in mind that clinical trials offer valuable insights into the medication's effectiveness and potential side effects.
If you're considering tirzepatide, clinical trials can help you make an informed decision. Based on current research, it's been shown to be most effective when combined with lifestyle changes such as diet and exercise. To learn more about how tirzepatide works and other related topics, visit mailMymeds' tirzepatide blog today.
The content in this article is intended for informational purposes only. This website does not provide medical advice. In all circumstances, you should always seek the advice of your physician and/or other qualified health professionals(s) for drug, medical conditions, or treatment advice. The content provided on this website is not a substitute for professional medical advice, diagnosis, or treatment.
