Study to Evaluate ARD-101 in Adults With Obesity

Inclusion Criteria

• Male and female subjects, 18-75 years of age
• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
• BMI of 30-45 kg/m2
• Stable body weight by subject report (± 5%) in the previous 6 months prior to randomization
• No abnormal findings or abnormalities of clinical significance in vital signs, physical examination, clinical laboratory tests (complete blood count (CBC), urinalysis, blood biochemistry, coagulation, pregnancy test (females of child bearing potential), urine drug test, nicotine test, etc.), 12-lead electrocardiogram (ECG) during the Screening Period.
• Serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and total bilirubin (unless the subject has documented Gilbert syndrome) not exceeding 1.5-fold the upper laboratory norm and estimated glomerular filtration rate (eGFR) >30 mL/min
• Standard 12-lead ECG parameters after 10 minutes resting in supine position in the following ranges; 120 ms 126 mg/dL OR HbA1c > 6.5% at screening
• Patients with type 2 diabetes treated with metformin may be enrolled. However, patients with type 2 diabetes on any other therapy will be excluded
• Female subjects must have negative serum pregnancy test and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single barrier method (i.e., sponge), or a double-barrier method of birth control (i.e., condom with spermicide) or abstinence must be used/practiced throughout the study and for 90 days following last dose of study medication; for effective form of birth control
• Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusion) or post-menopausal for at least 12 months (may be confirmed with a screening follicle stimulating hormone (FSH) level in the post-menopausal lab range), do not require contraception during the study
• Males with female partners of childbearing potential must agree to a double-barrier method if they become sexually active during the study and for 90 days following the last dose of the study medication. Male subjects must not donate sperm for 90 days following their participation in the study

Exclusion Criteria

• History of significant drug hypersensitivity or anaphylaxis
• Prior bariatric or GI surgery (excluding cholecystectomy, hysterectomy or appendectomy)
• Participation in a weight loss program or clinical trial for weight loss within 30 days prior to randomization
• Diabetes treatment (unless metformin as outlined), or chronic oral steroids, or treatment with immune modulators, anti-obesity drugs, chronic opiate therapy, or antipsychotic medications
• Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to randomization
• Currently receiving any drug-based therapy for weight management
• Thyroid-stimulating hormone (TSH) level is outside of normal limit
• The presence of diseases with abnormal clinical manifestations that need to be excluded based on their possible contribution to weight loss or weight gain, including but not limited to nervous, cardiovascular, blood and lymphatic system, immune, renal, hepatic, gastrointestinal, respiratory, metabolic and skeletal diseases
• History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 6 months prior to Visit 1
• Any malignancy not considered cured (except focal, treated basal cell carcinoma and squamous cell carcinoma of the skin); a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years
• History of major depressive disorder or history of other