The SURMOUNT-3 clinical trial is the third phase in the series of studies designed to assess Zepbound (tirzepatide) as a treatment for obesity and related health conditions. With the success of its predecessors, SURMOUNT 3 is looking to provide a more comprehensive understanding of how tirzepatide can be used among different demographics and health profiles.

The participants for this trial were ≥18 (mean age of 45.6 years). They were obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) excluding type 2 diabetes. The trial enrolled 806 participants and tested them at 62 sites across the U.S., including Puerto Rico, Argentina, and Brazil. The clinical trial has a 12-week lead-in period wherein participants are subjected to lifestyle modifications (diet and exercise) and 72 weeks of treatment with either Zepbound (10 mg or 15 mg) or placebo.

This trial is particularly significant as it addresses some limitations and questions asked in the previous studies. For instance, while SURMOUNT-1 and SURMOUNT-2 demonstrated the effectiveness of Zepbound in achieving weight loss, SURMOUNT-3 aims to explore its long-term effects, safety, and efficacy in maintaining weight loss over an extended period.

Surmount 3's clinical trial results are very comparable to their predecessors. During the 12-week lead-in period of lifestyle modifications, 579 (71.8%) participants lost ≥5% of their weight. They were qualified for the next step, which is the treatment of tirzepatide (10 mg or 15 mg) or placebo for the next 72 weeks. At the start of the study, the mean body weight was 241.4 lb. (109.5 kg). At the end of the 12-week lead-in period, participants achieved 6.9% (7.6 kg or 16.8 lb.) mean weight loss. In a co-primary endpoint, tirzepatide-taking participants lost an extra 21.1% mean weight after the lead-in period.

Participants reached a total mean weight loss of 26.6% (29.2 kg or 64.4 lb) over 84 weeks of study enrollment, according to a secondary endpoint. Over 84 weeks, the placebo group's participants lost a total of 3.8% (4.1 kg or 9.0 lb) in weight.

Tirzepatide's overall safety profile in SURMOUNT-3 was comparable to that of the SURMOUNT and SURPASS trials, which were previously published. In SURMOUNT-3, gastrointestinal-related adverse events were most frequently recorded, and they were typically mild to moderate in severity. 2.1% of participants using a placebo and 10.5% of persons getting tirzepatide discontinued their trial therapy due to adverse events.

When the SURMOUNT-3 trial is still in progress, there is a great deal of anticipation surrounding the results. Many individuals are doubtful about whether an obese person has to take medication to lose weight, according to Beverly Tchang, DABOM, M.D. an assistant professor of clinical medicine at Weill Cornell Medicine. Many continue to question, "Why don't you just follow a diet and exercise regimen? This trial provides evidence to refute the doubters. After three months, just 7% of the highly motivated individuals recruited in SURMOUNT-3 lost weight despite receiving all the recommended tools, including food, exercise, and behavioral therapy. While seven percent is still a respectable amount, most people desire more, and it's not in the slightest comparable to the 20% weight reduction that medications are causing. Early indications suggest that tirzepatide continues to demonstrate its potential as a powerful tool in the fight against obesity. Participants in the trial have reportedly experienced significant weight loss and improvements in other health markers, such as blood pressure and cholesterol levels.

In the final results of SURMOUNT-3, aligned with these early trends, Zepbound solidified its position as a leading treatment for obesity, just like in the previous SURMOUNT trials. Moreover, the broader patient population and longer study duration will provide critical data that could influence treatment guidelines and recommendations for obesity management.

The SURMOUNT-3 clinical trial’s result is crucial proof of the quest to develop effective and sustainable treatments for obesity. As obesity rates continue to rise globally, there is an urgent need for therapies that can help individuals achieve and maintain a healthy weight over the long term.

Zepbound's potential to address this need is significant, and the results of SURMOUNT-3 could have far-reaching implications for the future of obesity treatment. If successful, the trial could lead to wider approval and adoption of tirzepatide as a standard treatment for obesity, benefiting millions of people worldwide.

The SURMOUNT-3 clinical trial is a crucial study that seeks to expand our understanding of Zepbound (tirzepatide) as a treatment for obesity. By adding a lifestyle modification focusing on a more diverse patient population, and assessing long-term outcomes, the trial has the potential to provide valuable insights into the efficacy and safety of tirzepatide in managing obesity.

The SURMOUNT-3 continues the trend that tirzepatide is effective and safe for long-term weight management. It also showed an impressive average weight loss of 25%, similar to Surmount 1 and Surmount 2, with average weight losses of 23% and 15%, respectively. The success of SURMOUNT-3 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.