A Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation in Subjects With a Pathological Oral Glucose Tolerance Test

Inclusion Criteria:

• Male and female subjects 18 - 70 years of age

• Fully vaccinated against SARS-CoV-2.

• Body mass index 25-35 kg/m2

• Subjects with an impaired glucose tolerance defined as: HbA1c values ≥5.7% and ≤ 6.4%, and/or, Impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2hours of the Oral Glucose Tolerance Test (OGTT)) with or without impaired fastingglucose (fasting glucose between 100 and 125 mg/dL)

• Stable body weight: gain or loss in body weight ≤ 5% body weight over last 3 months

• History of at least one unsuccessful effort of lifestyle modification to loose >5%of body weight, completed at least 3 months prior to screening. Subject may havebeen treated with either diet or exercise alone.

• Willingness to undergo screening and all study procedures and examinations (i.e.,physical examinations and laboratory investigations before and after the treatmentperiods) and to wear a flash glucose monitoring device.

• Ability to comprehend subject information and willingness to sign the informedconsent.

Exclusion Criteria:

• Evidence of type 2 diabetes defined by fasting plasma glucose ≥ 126 mg/dL; 2-hourOGTT glucose ≥ 200 mg/dL

• Type I diabetes mellitus

• HbA1c ≥ 6.5%

• History of proliferative retinopathy or maculopathy

• Active COVID-19 infection proven by antigen positive Covid Test

• Treatment with any medication for weight loss within the past 3 months beforescreening.

• Prior or planned weight loss surgery for obesity

• Recent (within past 12 months) or planned endoscopic treatment for obesity.

• Proven history of bulimia or anorexia nervosa

• Eating habits consisting of eating relevant amounts of food throughout the night (after 10 p.m.; except if working on night shifts)

• Treatment with injectable anti-diabetic medications in the last 3 months (e.g.,GLP-1 receptor agonists, insulin)

• Treatment with dipeptidyl peptidase-4 inhibitors in the last 3 months

• Confirmed medical history of liver cirrhosis

• Positive test on Viral hepatitis (HbsAG, HCV)

• Positive test on Human immunodeficiency virus (HIV)

• Cholestatic disease

• Alcohol-related liver disease including alcoholic fatty liver, alcoholic hepatitisand alcoholic cirrhosis evidenced by confirmed history of alcohol use, abnormalliver function tests defined below, and complete blood count (CBC), and/or liverbiopsy.

• Abnormal liver function tests:

• Transaminases: Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN);or Aspartate aminotransferase (AST) ≥ 3x ULN;

• or Alkaline phosphatase (ALK) ≥2.5 x ULN

• or Total bilirubin ≥2 x ULN

• Stage 4 hypertension (systolic blood pressure (SBP) ≥ 180, diastolic BP (DBP) ≥ 110)

• History or presence of any uncontrolled cardiovascular, pulmonary, hepatobiliary,renal, hematological, gastrointestinal, endocrinologic, immunologic, dermatologic,neurological, psychiatric, metabolic, musculoskeletal, or malignant disease (exceptconditions accepted for inclusion) which the clinical investigator considers adisqualification for participation in the study.

• Prior or current treatment with drugs aimed to treat abnormal glucose homeostasisincluding oral antidiabetics, incretin analogues and/or insulin.

• History of uncontrolled illness (e.g. depression, psychosis) or behaviour that atthe discretion of the investigator might confound the study results or poseadditional risk in administering the study procedures.

• Illicit drug abuse

• Alcohol abuse

• Participation in another investigational drug/biologic or medical device studywithin 30 days of screening or will be enrolled in another investigational drug ormedical device study or any study in which active subject participation is requiredoutside normal hospital data collection during the course of the study.

• Failure to provide informed consent.

• Unwillingness or inability to comply with the study protocol or study-relatedprocedures.