Tirzepatide studies

The SURMOUNT-4 trial has shown remarkable results for eco-friendly weight management. Our analysis of this landmark study reveals that participants lost an impressive 25.3% of their weight with tirzepatide, whereas the placebo group achieved only 9.9%.

Weight loss has always been challenging to maintain. This clinical trial demonstrates a significant breakthrough in tackling this challenge. Participants (mean age 48 years, 71% women) lost a substantial 20.9% of their weight during the 36-week lead-in period. The results were even better, as 89.5% of people taking tirzepatide successfully maintained at least 80% of their original weight loss. The placebo group saw only 16.6% of participants achieve this milestone.

The results between the two groups couldn't be more different. The tirzepatide group lost an additional 5.5% of their weight from week 36 to week 88. The placebo group gained back 14% of their body weight. This resulted in a significant 19.4% difference between the groups. These tirzepatide clinical trials offer strong evidence that could revolutionize long-term weight management. In this piece, we'll get into the SURMOUNT-4 trial design, participant criteria, dosing protocols, and detailed outcomes. These findings could reshape the future of obesity treatment completely.

SURMOUNT-4 stands out as a phase 3 clinical trial that aimed to assess tirzepatide's effectiveness over time. Researchers conducted the study  from March 2021 to May 2023. The researchers designed this trial with two distinct phases. The first phase lasted 36 weeks, during which participants received tirzepatide in an open-label lead-in period. The second phase lasted 52 weeks, conducted as a double-blind, placebo-controlled study. A 4-week safety follow-up period completed the trial.at 70 sites across Argentina, Brazil, Taiwan, and the United States

The open-label phase started with 783 adults who received weekly tirzepatide injections under their skin. Each participant started with 2.5 mg doses that increased by 2.5 mg every four weeks until they reached their maximum tolerated dose (MTD) of either 10 mg or 15 mg. The trial proceeded with 670 participants following the lead-in phase. These participants split equally into two groups - one continued tirzepatide (n=335) while the other switched to placebo (n=335).

The team carefully divided participants based on: Country, Sex (female enrollment capped at 70%), Maximum tolerated dose (10 mg or 15 mg), Weight reduction response (<10% or ≥10%). The study welcomed adults 18 years or older who met these weight requirements:

or BMI ≥27 kg/m² (overweight) with at least one weight-related complication such as hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. The researchers excluded people with diabetes from the trial. They also excluded anyone who had undergone weight-loss surgery or planned to undergo one. People who had used weight-loss medications within the three months preceding their participation could not participate. Other exclusions applied to individuals with obesity due to endocrine disorders or those whose weight changed by more than 5 kg in the three months preceding screening.BMI ≥30 kg/m² (obesity)

The trial adhered to Good Clinical Practice guidelines and the principles outlined in the Declaration of Helsinki. Each participating site received approval from independent ethics committees. Every participant provided written informed consent.

The SURMOUNT-4 trial used a specific dose-escalation protocol for tirzepatide administration during both study phases. Patients received  in their abdomen, thigh, or upper arm.once-weekly subcutaneous injections

The protocol started with 2.5 mg tirzepatide doses that increased by 2.5 mg every four weeks. This careful approach continued until patients reached their maximum tolerated dose (MTD) of either 10 mg or 15 mg. Patients who handled 15 mg well stayed at that level. Those who managed 10 mg but struggled with 15 mg kept the 10 mg as their MTD.

The 36-week open-label lead-in period saw all 783 participants receiving tirzepatide under this protocol. After this phase ended,  who had successfully reached their MTD were randomly assigned to either continue their established tirzepatide dose or switch to a matching placebo for the next 52-week double-blind period. The protocol had clear guidelines for missed doses. Patients needed to take their injection within 4 days of missing it. After 4 days, they had to skip that dose and wait for their next scheduled injection. Please note that patients should not take two doses within 3 days of each other.670 participants

Additionally, qualified healthcare professionals provided lifestyle counseling throughout the study. They guided participants to: follow a healthy 500 kcal/day deficit diet, engage in at least 150 minutes of physical activity weekly, Rotate injection sites with each weekly dose

This carefully designed dosing protocol enabled researchers to assess the effectiveness of continued tirzepatide treatment compared to stopping it after the initial weight loss period.