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

Inclusion Criteria:

1. Male and female participants from 18 to 75 years of age 2. Able and willing toprovide 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 malesor < 50 mg/dL or 1.29 mmol/L for females v. Hypertension (systolic >130 mmHg and/ordiastolic > 85 mmHg) or treated for hypertension

Exclusion Criteria:

1. Significant medical condition, that in the opinion of the investigator, will placethe participant at risk during the study or that will confound the study endpoints

2. Active substance abuse including inhaled, oral, or injection drugs in the past 12months

3. Use of cannabis or cannabinoid-containing compounds within 90 days prior toscreening

4. Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, orunwillingness to use highly effective birth control during the study

5. History of significant liver disease or evidence of moderate to severe hepaticimpairment

6. History of epilepsy or intracranial surgery

7. Diabetes requiring medication for management (a diagnosis of diabetes that is wellcontrolled with diet and exercise is not exclusionary)

8. Bariatric surgery, use of a GLP-1 agonists or other weight-loss drug, or significantweight change (> 5 kg or 11 pounds) in the past 3 months

9. 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 incombination with bupropion)

10. Use of systemic corticosteroids (topical and inhaled corticosteroids are notexcluded)

11. Participants with an active diagnosis or history of a significant psychiatricdisorder, 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, bipolardisorder)

• Taking any of the following medications: antidepressants, atypicalantipsychotics and mood stabilizers such as imipramine, amitriptyline,mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine,olanzapine, valproic acid, lithium

12. Score on the 9-question Patient Health Questionnaire (PHQ-9) of

13. Current or active malignancy within the past 5 years, except for cancer in situ, ornonmelanoma skin cancer, such as basal cell or squamous cell carcinoma that has beencompletely resected

14. A history thyroid disease; the only exception would be a participant who hasundergone a complete thyroid ablation/resection

15. QTc > 500 ms at baseline

16. Any chronic medications with effects on blood pressure, lipids, or blood glucosestarted or changed within the past 3 months or at risk of requiring a change duringthe study

17. Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6, or 2C19 by screening; these medications are prohibited during the entire duration ofthe study

18. Having taken any investigational compound within 30 days, or 5 half-lives of thedrug, whichever is longer, before the screening visit

19. Previous use of INV-202

20. Participants that, in the opinion of the investigator, are unsuitable for the studyor unlikely to comply with all study procedures and treatment