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jan, 2024  /  3 min. read

Understanding the SURMOUNT-2 Clinical Trial: Zepbound's Continuous Study for Obesity Treatment

With the success of the first Zepbound phase 3 clinical trial, more study openings were being explored. The Surmount 2 clinical trial aims to tackle a different population looking to manage their weight effectively. Zepbound (Tirzepatide) is still used in this trial, focusing on its efficacy and safety in managing weight and related health conditions.

The Surmount 2 Trial: An Overview

Surmount 2 is the second trial for Zepbound (Tirzepatide). While the first phase 3 clinical trial showed promising results, Surmount 2 aims to investigate the potential of Zepbound targeting a different population with different obesity-related health conditions.

Surmount 2 clinical trials were conducted on participants who are obese (BMI ≥27 kg/m2) with type 2 diabetes and HbA1c of 7–10% (53–86 mmol/mol). The clinical trial was conducted on 938 participants with a mean age of 54.2 who were randomly assigned and received at least one dose of Tirzepatide (10 mg), Tirzepatide (15 mg), or placebo weekly in 75 sites in eight countries and lasted for 72 weeks.

Key Objectives and Outcomes

The primary objective of the SURMOUNT-2 trial is to evaluate the efficacy of Zepbound in achieving weight loss in the study population. This is measured by the percentage of body weight lost from baseline throughout the trial. Additionally, the study aims to assess the drug's safety profile by monitoring adverse events and side effects experienced by participants.

Secondary objectives of the trial include evaluating the impact of Zepbound on other health markers, such as blood sugar levels, blood pressure, and lipid profiles. The trial also seeks to determine whether Zepbound can help improve overall quality of life and reduce the risk of developing obesity-related complications.

Results and Findings

SURMOUNT 2 results were again proven effective in managing weight loss versus the placebo group. It is strengthening and solidifying the results of Surmount 1 and broadening the reach of populations that can use the Zepbound (Tirzepatide) drug. The baseline for the mean body weight was 100.7 kg. It is essential to measure the baseline so that they have a basis to see if the medication worked after the 72-week clinical trial.

These weight loss outcomes were recorded on week 72. The efficacy estimand for mean weight loss percentages and their corresponding value in pounds/kg are the following: 13.4% (29.8 lb. or 13.5 kg), 15.7% (34.4 lb. or 15.6), and 3.3% (7.0 lb. or 3.2 kg).

Compared to those on a placebo, participants taking Zepbound (Tirzepatide) saw a significant decrease in their waist circumference and body weight.

Other Benefits

Since Surmount 2’s participants have type 2 diabetes, they also checked if it lowered the HbA1C of the patients, and it is shown that they achieved a <5.7%, considered well-controlled blood sugar levels. 55.3% of the patients took 10 mg and 50.2% took 15 mg, compared to 2.8% taking a placebo. It also reduced their fasting blood glucose. 49.2 mg/dL for patients taking 10 mg and 51.7 mg/dL (15 mg), compared to 2.4 mg/dL with a placebo.

In comparison to the placebo, systolic blood pressure (-7.2 mmHg vs. -1.0 mmHg), fasting triglycerides (-28.6% vs. -5.8%), HDL cholesterol (8.2% vs. 1.1%), and non-HDL cholesterol (-6.6% vs. 2.3%) all showed significantly higher improvements with pooled Tirzepatide doses (10 mg and 15 mg).

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Safety Profile

The overall safety and tolerability profile of tirzepatide was comparable to those of other incretin-based therapies that were approved for the treatment of obesity. The majority of adverse effects were mild to moderate in severity and were connected to the gastrointestinal tract. They mostly happen during the dose escalation phase and gradually go away as your body adjusts to the medication.

Two deaths happened in the Tirzepatide 10 mg group, and 68 individuals (7%) experienced serious adverse events overall. However, the investigator did not believe that the deaths were connected to the research medication.

The Future of Obesity Treatment

The SURMOUNT-2 trial represents a significant step forward in the ongoing quest to develop effective treatments for obesity. The positive result of Surmount 2 is a good basis for helping medical practitioners choose it as an option for patients in need of losing weight.

As the trial progresses, researchers and healthcare providers are patiently waiting for the final results, which could pave the way for new treatment guidelines and expanded access to Zepbound. For patients with type 2 diabetes and struggling with obesity, the SURMOUNT-2 trial offers hope for a brighter, healthier future.

Conclusion

The SURMOUNT-2 clinical trial is a critical study in the ongoing evaluation of Zepbound (Tirzepatide) as a treatment for obesity. By focusing on a diverse population and assessing both efficacy and safety, this trial has the potential to significantly impact the future of obesity treatment. As we await the final results, the promise of Zepbound continues to shine, offering new hope for those seeking effective weight management solutions.

SURMOUNT-1 first demonstrated the significant weight loss (~20%) associated with Tirzepatide up to 15 mg in obese patients without diabetes. W. Timothy Garvey, MD, MACE, MABOM, Professor of Medicine at the University of Alabama at Birmingham (UAB), Director of the UAB Diabetes Research Center and Principal Investigator of SURMOUNT-2. stated that "People living with type 2 diabetes in many cases have been exposed to excess weight for years and often face increased difficulties in achieving weight loss results, typically losing 30% less weight than those who have obesity without type 2 diabetes. They need options to help overcome those challenges and achieve meaningful weight reductions". Despite this, the current data highlight the still-sizable effect of Tirzepatide on weight loss in this more challenging population.

The success of SURMOUNT-2 provides an avenue for additional research on the long-term safety and efficacy of the treatment in other groups (e.g., children, the elderly, patients with severe obesity and diabetes), as well as combination therapies with other drugs for weight loss or lifestyle modifications.

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