In recent years, the quest for effective treatments for obesity has been rapidly progressing. Surmount 1 clinical trial is joining the quest and is a crucial study in this field. Zepbound (Tirzepatide) is the medication evaluated in this trial. It is a medication aimed at addressing the growing global obesity epidemic. In Surmount 1, Eli Lilly and Company explores the efficacy and safety of Zepbound (Tirzepatide) in managing weight and related health conditions.
What is SURMOUNT-1?
Surmount 1 is the first phase 3 clinical trial for Zepbound (Tirzepatide). This study assessed the effectiveness and safety of Zepbound (Tirzepatide) in individuals with obesity. Phase 3 trials are the SURMOUNT-1 trial, a multicenter, double-blind (neither the participants nor the researcher know which treatment or intervention participants are receiving until the clinical trial is over), placebo-controlled study. Participants were randomly assigned to receive either Zepbound or a placebo.
The Surmount 1 clinical trial was conducted on participants who are obese (BMI of 30 or higher, or a BMI of 27 or higher) with at least one comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease). The trial was conducted on 119 sites in nine countries and lasted 72 weeks.
2539 adult participants with a mean age of 44.9 years were treated with once-weekly subcutaneous Tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks, including a 20-week dose-escalation period.
Results and Findings
The results from the SURMOUNT-1 trial were promising and highlighted the potential of Zepbound as an additional transformative treatment for obesity. Participants started with a baseline to determine the change in body weight and waist circumference after the 72-week trial. The mean body weight was 104.8 kg, and the mean waist circumference was 114.1 cm.
These weight loss outcomes are recorded on week 72. The efficacy estimand for the mean weight loss percentages and their corresponding value in pounds/kg are the following: 16.0% (35.5 lb. or 16.1 kg), 21.4% (48.9 lb. or 22.2 kg), 22.5% (52 lb. or 23.6 kg), 2.4% (5.3 lb. or 2.4 kg).
Participants receiving Zepbound (tirzepatide) experienced a significant reduction in body weight and waist circumference compared to those on placebo.
Other benefits
Although the study focuses on weight loss they have observed that Zepbound-treated patients showed improvements in metabolic markers, including reductions in blood sugar levels, improvements in lipid profiles, and blood pressure levels. At week 72, most (95.3%) of the participants with prediabetes at baseline in the Tirzepatide groups had reverted to normoglycemia (normal blood sugar levels), compared with 61.9% of participants in the placebo group. The mean reduction in total body fat mass was 33.9% with Tirzepatide, compared with 8.2% with placebo.
Safety Profile
Tirzepatide's overall safety and tolerability profile matched that of other incretin-based treatments that have been authorized for the management of obesity. The most common side effects were gastrointestinal-related issues and generally mild to moderate in severity, it usually occurred during the dose escalation period and decreased over time. Overall, 78.9 to 81.8% of patients receiving Tirzepatide reported at least one side effect that occurred while they were receiving the medication, compared to 72.0% of patients receiving a placebo.
Serious side effects were reported by 160 participants (6.3%). Coronavirus was the most prevalent case of adverse effects because the trial was initiated in December 2019 and conducted entirely during the Covid-19 pandemic. More than 20% have serious adverse events judged to be related to Covid-19 and nearly 11 deaths are directly attributed to Covid-19.
Implications for Obesity Treatment
The success of the SURMOUNT-1 trial represents a major advancement in obesity treatment. The positive results of Zepbound's clinical trial to help with weight loss and improve metabolic health offer a new option for practitioners to prescribe to individuals who are struggling with obesity, particularly those who have not seen enough improvement in their weight management through lifestyle adjustments alone.
The trial's results suggest that sustained use of Zepbound could lead to long-term weight management and associated health benefits, potentially reducing the risk of obesity-related complications such as diabetes and cardiovascular disease.
Conclusion
The SURMOUNT-1 clinical trial shows potential as a revolutionary treatment for obesity. Zepbound is a promising new tool for healthcare providers in the fight against obesity. The clinical trial suggests that Zepbound can play a role in long-term weight management and reduce the risk of developing obesity-related health conditions like diabetes, high cholesterol, and cardiovascular diseases. As the global burden of obesity continues to grow, the success of Zepbound in the SURMOUNT 1 trial is a significant step towards providing more effective solutions for the growing health issue. This also opens a way for further research into exploring the long-term safety and effectiveness in different populations (e.g., children, the elderly, and patients with severe obesity and diabetes) and combination therapies with other weight loss medications or lifestyle interventions.
