Study of INV-202 in Patients With Obesity and Metabolic Syndrome

Prior treatment

• Active substance abuse including inhaled, oral, or injection drugs in the past 12 months
• Use of cannabis or cannabinoid-containing compounds within 90 days prior to screening
• Bariatric surgery, use of a GLP-1 agonists or other weight-loss drug, or significant weight change (\> 5 kg or 11 pounds) in the past 3 months
• Participants taking any drug that may be used for weight loss (eg, liraglutide, semaglutide, tirzepatide, orlistat sibutramine phenylpropanolamine , mazindol , phentermine alone or in combination with topiramate, lorcaserin , naltrexone in combination with bupropion)
• Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded)
• Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6, or 2C19 by screening; these medications are prohibited during the entire duration of the study
• Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit
• Previous use of INV-202

Other illness

• Significant medical condition, that in the opinion of the investigator, will place the participant at risk during the study or that will confound the study endpoints
• History of significant liver disease or evidence of moderate to severe hepatic impairment
• History of epilepsy or intracranial surgery
• Diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary)
• Participants with an active diagnosis or history of a significant psychiatric disorder, including but not limited to the following:
  • Major depression within the last 2 years
  • Any history of a suicide attempt or suicidal ideation
  • A history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
  • Taking any of the following medications: antidepressants, atypical antipsychotics and mood stabilizers such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium
• Current or active malignancy within the past 5 years, except for cancer in situ, or nonmelanoma skin cancer, such as basal cell or squamous cell carcinoma that has been completely resected
• A history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection

Lab values

• QTc \> 500 ms at baseline
• Any chronic medications with effects on blood pressure, lipids, or blood glucose started or changed within the past 3 months or at risk of requiring a change during the study

Other

• Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study
• Score on the 9-question Patient Health Questionnaire (PHQ-9) of
• Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment

• 1\. Male and female participants from 18 to 75 years of age 2. Able and willing to provide informed consent and to comply with scheduled visits and study procedures 3. BMI ≥ 30 kg/m2 4. Presence of at least 3 of the 5 following criteria at screening: i. Increased waist circumference (males, ≥40 inches; females, ≥35 inches) ii. Fasting glucose ≥ 100 mg/dL in the last 3 months or an HgbA1C \> 5.7% iii. Triglycerides ≥ 150 mg/dL or 1.69 mmol/L iv. HDL \< 40 mg/dL or 1.03 mmol/L for males or \< 50 mg/dL or 1.29 mmol/L for females v. Hypertension (systolic \>130 mmHg and/or diastolic \> 85 mmHg) or treated for hypertension