Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions

Exclusion Criteria

• •1. Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
• •2. Have a prior or planned surgical treatment for obesity.
• •3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner.
• •4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
• •1. Diabetes.
• •2. Have a history of acute or chronic pancreatitis.
• •3. Have current symptomatic gallbladder disease or biliary disease.
• •4. Have known liver disease other than MASLD.
• •5. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
• •6. Have a serum calcitonin ≥20 pg/mL.
• •7. Have an eGFR \<30 mL/min/1.73 m², as determined by the central laboratory at screening.
• •8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
• •9. Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1.