Background and Objective: Plenity is a non-systemic oral superabsorbent hydrogel which promotes fullness by increasing the volume and elasticity of ingested food in the stomach and small intestine. The efficacy and safety of the oral hydrogel have been demonstrated in clinical trials. This study evaluated weight change in people with overweight or obesity following treatment with the oral hydrogel in a real-world setting.
Research Design and Methods: Data was analyzed using chart records from a national telehealth platform. Demographic and health information and anthropometric measures were self-reported by patients during online visits. Patients were included in the analysis if they had received a prescription for the oral hydrogel, had a follow-up visit at 180 ± 30 days, reported having access to treatment for ≥ 75% of days, and reported taking it at least 1 day per week. Descriptive statistical analysis and tests of differences (χ2, t-tests) were performed in R Version 4.2.2.
Results: Patients (n=894) were 74% female, aged 50 ± 11 years, with a mean pre-treatment body weight of 90 ± 16 kg and BMI of 32.0 ± 4.1 kg/m2. One-third (35%) of patients had overweight (BMI 25-30 kg/m2) at baseline and mean treatment duration was 160 ± 16 days. Weight loss of any amount (>0 kg) was reported by 85.9% of patients, with a mean weight change of -6.1 ± 3.9% (-5.6 ± 3.8 kg) in this group. About half (48%) of all patients achieved clinically significant weight loss of ≥ 5%. Among these treatment responders, mean weight loss was 8.7 ± 3.3% (8.0 ± 3.4 kg). Clinically significant weight loss response ≥ 5% was more likely among people that reported poor baseline diet quality (P = 0.02).
Conclusions: Treatment with an oral superabsorbent hydrogel in people with overweight and mild obesity in a real-world environment was associated with clinically significant weight loss response at 6 months. People with self-assessed poor baseline diet quality, in particular, were more likely to have a meaningful response to therapy.
D. Bialonczyk: Employee; Gelesis. M. S. Zhou: Employee; Ro. L. Broffman: Employee; Roman Health Adventures. T. Y. Doron: Employee; Roman Health Adventures. J. Bowles: Employee; MCPHS University, Gelesis. E. Chiquette: Consultant; Gelesis.