This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.

Inclusion Criteria:

1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent.

2. Hemoglobin A1c (HbA1c) <6.5% at screening.

3. BMI ≥30 kg/m².

4. BMI ≥27 kg/m² and <30 kg/m² with at least 1 weight-related comorbidity:

   • hypertension
   • dyslipidemia
   • cardiovascular (CV) disease
   • obstructive sleep apnea

5. Have a stable body weight (< 5% change) for the 3 months prior to randomization.

Exclusion Criteria (Obesity Related):

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.

Exclusion Criteria (Medical Conditions)

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.

The Sponsor recognizes that sharing anonymized data and other information from clinical trials can enhance biomedical research. The Sponsor is following ongoing discussions among industry, academia, and other stakeholders regarding data sharing. Industry and academic partners hold various positions on the amount, types, and forms of data that will be useful l to the research community, the public, and the process for sharing. As a small, young company, the Sponsor awaits further guidance and input from industry participants on best practices before issuing a comprehensive data sharing plan. For now, Sponsor defers a description of what data will be shared and the process for doing so.