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

Prior treatment

• Have a prior or planned surgical treatment for obesity.
• 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.
• Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
• 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.

Other illness

• 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).
• Diabetes.
• Have a history of acute or chronic pancreatitis.
• Have current symptomatic gallbladder disease or biliary disease.
• Have known liver disease other than MASLD.
• Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.

Lab values

• Have a serum calcitonin ≥20 pg/mL.
• Have an eGFR \<30 mL/min/1.73 m², as determined by the central laboratory at screening.

Other

• 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).

• Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
• Hemoglobin A1c (HbA1c) \<6.5% at screening.
• BMI ≥30 kg/m².
• BMI ≥27 kg/m² and \<30 kg/m² with at least 1 weight-related comorbidity:
  • hypertension
  • dyslipidemia
  • cardiovascular (CV) disease
  • obstructive sleep apnea
• Have a stable body weight (\< 5% change) for the 3 months prior to randomization.