Tirzepatide Weight Loss Trial
Obesity is one of the biggest health challenges of our time. The chronic disease impairs the quality of life increasing the risk of other serious conditions such as
In addition, it also increases the risk of several types of cancer.
Surgery that reduces the patient’s stomach, combined with lifestyle changes, is the most effective obesity treatment. But in recent years, several drugs for chronic diseases have also been developed. There are currently four approved anti-obesity drugs in the EU; orlistat, liraglutide, naltrexone/bupropion and semaglutide.
The former works by reducing fat absorption in the intestine and the remaining three by controlling the appetite.
Tirzepatide FDA Approval
In the current study, the researchers examined tirzepatide, a so-called GIP / GLP 1 agonist. It stimulates receptors for glucose-dependent insulin-releasing peptide GIP and glucagon-like peptide 1, GLP 1. One of them affects food intake and energy consumption. And the other amplifies the effect. Tirzepatide was recently approved in the United States as a treatment for type 2 diabetes.
The study was a randomized, placebo-controlled phase III study with 2,539 adult participants. They had a body mass index, BMI of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes. The mean age was 44.9 years, and 67 per cent of the participants were women. The study started in December 2019 and was conducted in nine countries.
For 72 weeks, participants received either tirzepatide (5 mg, 10 mg or 15 mg) or a placebo once a week. The treatment period was up to 20 weeks. Participants would also eat balanced meals with a deficit of 500 calories per day and engage in physical activity for at least 150 minutes per week.
In total, 86 per cent of the participants completed the treatment. At the study’s end, the weight loss percentage was:
-15 per cent in those who received 5 mg of tirzepatide
-19.5 per cent of those who had received 10 mg
-29 per cent of those who had received 15 mg.
In the placebo group, the average weight loss was 3.1 per cent.
The results also showed improvements in, among other things, waist measurements, blood pressure, fasting insulin levels and lipid levels. 95.3 per cent of participants with prediabetes at the beginning of the study had returned to normal blood sugar levels after 72 weeks. The corresponding figure in the placebo group was 61.9 per cent.
About 10% of participants who had received tirzepatide reported at least one side effect.
This can be compared with 72 per cent in the placebo group. The most common side effects were nausea, diarrhoea and constipation with mild or moderate severity. More side effects occurred when tirzepatide was increased.
Six% of participants reported severe side effects. These were evenly distributed across the drug groups and the placebo group. In total, 21% of these were related to covid-19. Eleven deaths were reported, seven in the drug group and four in the placebo group.
What Are Tirzepatide Side Effects?
According to the researchers, tirzepatide shows an “unusually significant degree” of weight loss. They also note that there was an expected effect on the occurrence of side effects, as the study was conducted almost entirely during the corona pandemic.
The researchers point out, among other things, the sample size and that the vast majority completed the treatment as some of the study’s strengths. They make the results relatively generalizable, they say.
One limitation they mention is that the participants in the study may represent a subpopulation with a more significant commitment to losing weight than the general population with obesity.
They also mention that only 5.5% of the participants had a BMI between 27 and 30, which counts as overweight. Therefore, further studies are needed in this patient group.
Tirzepatide Weight Loss Trials: A Breakthrough In Obesity Management
In a groundbreaking clinical trial published in The New England Journal of Medicine (NEJM), Tirzepatide has emerged as a game-changer in weight management. This innovative medication, initially developed to combat type 2 diabetes, has shown remarkable efficacy in promoting substantial weight loss, offering newfound hope to those grappling with obesity.
The study, available at https://www.nejm.org/doi/full/10.1056/NEJMoa2206038, showcases the results of a rigorous investigation into Tirzepatide’s effects on body weight and overall health. Here’s a glimpse of the key findings:
- Significant Weight Reduction: Tirzepatide participants experienced substantial weight loss throughout the trial. This effect was particularly notable, considering many individuals’ challenges in achieving and maintaining healthy weight.
- Enhanced Metabolic Control: Beyond weight loss, Tirzepatide demonstrated its prowess in improving metabolic parameters, including better glycemic control and reduced waist circumference. These improvements are crucial for overall health and well-being.
- Tolerability: The trial assessed the safety and tolerability of Tirzepatide, a vital aspect of any medication. While some side effects were observed, they were manageable and did not diminish the medication’s potential benefits.
- Long-Term Potential: The study’s duration allowed researchers to assess Tirzepatide’s performance over a more extended period, offering insights into its sustainability as a weight loss intervention.
These findings suggest that Tirzepatide has the potential to revolutionize the approach to obesity management. It represents a new frontier in weight loss therapeutics, offering hope to millions of individuals struggling with this complex and pervasive health issue.
As the research on Tirzepatide continues to evolve, it holds promise not only in the fight against obesity but also in addressing related conditions, such as type 2 diabetes and cardiovascular health. Stay tuned for further developments in the exciting journey of Tirzepatide research and its transformative impact on healthcare.
Is there an expected approval date for tirzepatide for weight loss in 2023?
On November 8, 2023, Eli Lilly and Company’s Zepbound™ (tirzepatide) received approval from the U.S. Food and Drug Administration (FDA). It marks a significant milestone as it becomes the first and only obesity treatment to activate both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide).
How quickly does Tirzepatide induce weight loss?
Clinical trials show Tirzepatide’s weight loss effects become noticeable over time as it gradually increases. Many individuals observe changes in their weight within 4 to 6 weeks after starting the treatment. Incorporating a healthy diet and exercise regimen alongside Tirzepatide treatment can maximize its effectiveness for optimal results.