A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes

Inclusion criteria

• ✓. Males \& females between 18 years of age or older
• ✓. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
• ✓. Individuals eligible for, but not currently taking, semaglutide therapy as per standard-of-care including adults with:
• ✓. Prediabetes (HbA1c 6.0-6.5%) who are treatment naïve
• ✓. Type 2 Diabetes (HbA1c 6.5-7.5%) who are treatment naïve and metformin is inappropriate due to contraindication or intolerance
• ✓. Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline
• ✓. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, use of nicotine, tobacco and cannabinoid products) as much as possible throughout the study
• ✓. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits

Exclusion criteria