View Abstract in the Obesity Journal, Oral-053
Jamy Ard, MD Winston-Salem NC, Donna Ryan, MD, FTOS, MABOM New Orleans LA, Patrick O’Neil, PhD Charleston SC, Robert Kushner, MD Chicago IL, Frank Greenway, MD, FTOS Baton Rouge LA, Harold Bays, MD, FTOS, FOMA, FACC, FNLA, FASPC Louisville KY, Holly Wyatt, MD Birmingham AL, John Jakicic, PhD, FTOS, FACSM Kansas City KS, Damaris Vega, MD, Yael Kenan, PhD, Ruthie Amir, MD Ceasarea, Odd Erik Johansen, MD, PhD Vevey, Thomas Wadden, PhD Philadelphia PA
Background: The Epitomee Capsule (EC) is a novel self-consumed, oral, pH-sensitive medical device for weight loss, composed of polymers and bonding materials, that expands in the stomach to create a transient space-occupying hydrogel based structure. The 24-week, 1:1, double-blind Randomized evaluation of Efficacy and Safety of the Epitomee capsule Trial (RESET) investigates the weight loss potential of the EC before meals versus placebo capsule (both taken with water), along with lifestyle counseling (diet, physical activity, and behavior therapy) in adults (age ≥ 18 years) with BMI 27–40 kg/m2, who previously have attempted medically supervised or self-directed weight reduction and who have normoglycemia or prediabetes. The trial (NCT04222322) initiated Sept 2020.
Methods: The trial involves nine sites across the US. There are two co-primary endpoints at week 24: body weight loss from baseline (BL) and proportion with ≥5% weight loss from BL. The number of participants, required to achieve 90% power for the primary endpoint, was determined by an independently conducted and prespecified interim sample-size re-estimation, with an a priori assumption of a range of n = 230–600. Recruitment was completed Jan 2023.
Results: Mean (SD) age is 49(12) years, and 80% of participants are female. Most self-reported race as White (69%) or Black (23%), with 3% as Asian and 5% other/not reported. BL weight is 96(15) kg, waist circumference 107(11) cm, BMI 33.9(3.3) kg/m2 (BMI 27.0–29.9: 13%; BMI 30.0–34.9: 46%; BMI ≥35: 41%) and eGFR (EPI-CKD) 88.9(17.2) mL/min/1.73 m2. Overall, 40% have prediabetes (HbA1c 5.8(0.3)%, fasting plasma glucose (FPG) 99 (21) mg/dL), and 60% are normoglycemic (HbA1c 5.3 (0.2)%, FPG 87 (7) mg/dL). Systolic/diastolic blood pressure is 121(14)//78(10) mmHg, triglycerides 111 (53) mg/dL, and alanine aminotransferase 23(17) U/L, all higher with increasing categories of BMI. The total score on the Impact of Weight on Quality of Life- Lite questionnaire is 60(18), and is inversely related to BMI.
Conclusions: BL characteristics of participants in RESET are broadly representative of individuals with overweight or obesity seeking weight loss treatment and indicate recruitment of an appropriate population. This will allow an adequate investigation of the safety and effectiveness of the EC for weight-reduction. Results are expected quarter 42,023.