Title: Patient-Reported Outcomes with Semaglutide Sublingual Suspension for Wellness: A Prospective Observational Study.
Authors: Jonathan Reynolds; Brandon Sucher
Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have increased in use for the treatment of obesity. This class of medications is associated with weight loss through activation of GLP-1 receptors, which delays gastric emptying and increases satiety. While effective for weight loss, injectable GLP-1 RAs are associated with gastrointestinal side effects, high cost, and the need for subcutaneous injections. In December 2025, semaglutide 25 mg oral tablets were approved by the FDA for the treatment of obesity, providing an alternative formulation for patients. The OASIS-4 clinical trial evaluated the use of semaglutide 25 mg oral tablets dosed once daily for 64 weeks in overweight or obese adults. At the conclusion of this study, the mean percent change in body weight from baseline to week 64 was -13.9%, and the proportion of patients with a weight loss greater than 5% was 79.2%. The most common adverse effects were nausea (46.6%), vomiting (30.9%), constipation (20.1%), dyspepsia (18.1%), and diarrhea (17.6%). Allergic reactions occurred in 3.9% of patients. Health care providers have prescribed compounded semaglutide sublingual (SL) suspension as an alternative to injectable GLP-1 RAs. This study aims to evaluate patient-reported outcomes from patients prescribed compounded semaglutide SL suspension.
Methods: This prospective observational study utilized patient reported outcomes obtained from patients prescribed compounded semaglutide SL suspension from March 2025 to February 2026. All adult patients who received a prescription for compounded semaglutide SL suspension within a network of 20 compounding pharmacies were eligible. Eligible patients were emailed a link to complete a patient-reported outcome measure (PROM). Patients who did not initially complete the PROM received up to two reminder emails. There were no exclusion criteria for this study. The primary endpoint was the mean percent change in body weight from baseline. Secondary endpoints included overall satisfaction, post-meal fullness, adverse drug reactions, allergic reactions, and the proportion of patients achieving weight loss greater than 5%. Descriptive statistics were used to report data.
Results: A total of 382 PROMs were emailed to patients, and 47 responses were received (12.3% response rate). The median dose reported was 4 mg SL once daily, and the median duration of therapy was 2 to 3 months. The mean percent change in weight was -1.9%. The median overall satisfaction reported was “somewhat satisfied,” and the median post-meal fullness was “moderately full.” Of the 47 patients, 8 (17%) achieved a weight loss greater than 5%. Two patients (4%) reported adverse reactions. One patient experienced constipation, headache, and fatigue, while the second patient experienced tooth sensitivity. Two patients experienced allergic reactions (4%), with one resulting in treatment discontinuation. One patient reported difficulty performing daily activities. The allergic reactions reported were not life-threatening and did not require hospitalization.
Conclusion: Compounded semaglutide SL suspension at a median dose of 4 mg once daily was associated with a weight loss of 1.9% over a median duration of 2 to 3 months. The proportion of patients achieving weight loss greater than 5% was 17%. Patients reported a median level of overall satisfaction as “somewhat satisfied,” and a median post-meal fullness of feeling “moderately full.” Compounded semaglutide SL suspension demonstrated a favorable safety profile with a low incidence of reported adverse effects (4%) and allergic reactions (4%). While some benefit was seen, higher doses and a longer duration of compounded semaglutide SL suspension may demonstrate more favorable patient-reported outcomes.
