About The SURMOUNT-4 Trial
Study Name: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
ClinicalTrials.gov ID: NCT04660643
Sponsor: Eli Lilly and Company
Study Completion: May 2023
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Tirzepatide Results in Superior Mean Percent Change in Body Weight for Those with Obesity
In the phase 3 SURMOUNT-4 trial, investigators included individuals with at least 1 weight-related complication, including hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.
Tirzepatide (Zepbound; Eli Lilly and Company) injection achieved a superior mean percent change in body weight for those with obesity or overweight with weight-related comorbidities, including cardiovascular disease (CVD) but excluding type 2 diabetes, when compared to the placebo, according to results published in JAMA.1,2
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In the phase 3 SURMOUNT-4 trial, individuals receiving tirzepatide also maintained at least 80% weight loss during the lead-in period at week 88 when compared to the placebo at 16.6%, according to the results.2 Tirzepatide met the primary endpoint as well as all key secondary endpoints.1
"Patients, providers, and the public do not always understand obesity is a chronic disease that often requires ongoing treatment, which can mean that treatment is stopped once weight goals are met," Jeff Emmick, MD, PhD, senior vice president of product development at Eli Lilly, said in a statement. "However, studies like SURMOUNT-4 show that continued therapy can help [individuals] living with obesity maintain their weight loss."2
The SURMOUNT-4 trial was intended to evaluate the safety and efficacy of tirzepatide compared to the placebo. It was split into 2 periods: an open-label lead-in period that was 36 weeks long where individuals took tirzepatide at the maximum tolerated dose and a double-blind treatment period where individuals randomly received tirzepatide or switched to the placebo for 52 weeks.2
The maximum tolerated dose was 10 mg or 15 mg once weekly, with the starting dose of 2.5 mg increased by 2.5 mg every 4 weeks until the maximum dose was achieved, according to the press release. Those who tolerated the 15 mg continued that dosage as the maximum tolerated dose, and those who could not tolerate the dose continued on 10 mg as the maximum tolerated dose.2 Secondary endpoints included improved body mass index, fasting insulin, lipids, blood pressure, and health-related quality of life.2
There were 670 individuals included in the study, with 71% women and a mean age of 48 years and mean weight of 107.3 kg.1 Individuals in the study had at least 1 weight-related complication, including hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Exclusion criteria included diabetes, prior or planned surgical treatment for obesity, and treatment with medication resulting in weight loss within 3 months prior to enrollment.1 The study authors reported that individuals in the lead-in period had a mean weight reduction of 20.9%, with a mean percent weight change from week 36 to 88 of -5.5% compared to 14% for the placebo.1
Furthermore, the overall mean weight reduction from 0 weeks to 88 weeks was 25.3% for those receiving tirzepatide and 9.9% for those on the placebo. In the safety analysis, the most common adverse events (AEs) were mostly mild to moderate gastrointestinal (GI) events, occurring more commonly with tirzepatide, according to the study authors.1
The most frequent AEs in the lead-in treatment included nausea, diarrhea, constipation, and vomiting. For the double-blind period, the most frequent AEs were diarrhea, nausea, vomiting, COVID-19, and upper respiratory infection. Discontinuation due to AEs occurred for 7% of those enrolled in the 36-week lead-in period, mainly due to GI events. Discontinuation in double-blinded period occurred in 1.8% for tirzepatide and 0.9% for the placebo.1
References
- Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. Published online December 11, 2023. doi:10.1001/jama.2023.24945
- Lilly’s Zepbound (tirzepatide) achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks. News release. Eli Lilly. December 11, 2023. Accessed December 12, 2023. https://investor.lilly.com/news-releases/news-release-details/lillys-zepboundtm-tirzepatide-achieved-additional-67-weight-loss
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