A Study to Investigate the Efficacy and Safety of Two Different Doses of Twice Daily Distal Jejunal-release Dextrose Beads Formulations Combined With a Gel Composition Compared to Placebos in Obese Subjects With Weight Related Comorbidities
Trial Parameters
Brief Summary
The goal of this randomized, double-blind, placebo-controlled, phase IIa study is to demonstrate superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (APHD 012 and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (APHP 012 and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities.
Eligibility Criteria
Inclusion Criteria: * Male and female subjects between an age of 18 (or the legal age of consent in the jurisdiction where the study is conducted) and 75 at the time of signing Informed Consent Form (ICF). 2\. Body Mass Index (BMI) of 1. ≥30 kg/m2 2. ≥27 kg/m2 and \<30 kg/m2 with at least 1 of the following weight-related comorbidities * hypertension: on blood-pressure (BP)-lowering medication or having systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg at Screening * dyslipidaemia: on lipid-lowering medication or having low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) \<40 mg/dL (1.0 mmol/L) for men or HDL \<50 mg/dL (1.3 mmol/L) for women at Screening * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association \[NYHA\] Functional Classification Class I-II heart failure.) * obstructive sleep apnoea (only in participants \>30 years of age) 3. Stable body weigh