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

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inversago Pharma Inc.

Criteria

Inclusion Criteria:

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: 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 in the last 6 months iv. HDL < 40 mg/dL for males or < 50 mg/dL for females in the last 6 months v. Hypertension (systolic >130 mmHg and/or diastolic > 85 mmHg)

Exclusion Criteria:

1. 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

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

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

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

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

6. History of epilepsy or intracranial surgery

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

8. 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

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 in combination with bupropion)

10. Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded)

11. 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

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, or nonmelanoma skin cancer, such as basal cell or squamous cell carcinoma that has been completely resected

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

15. QTc > 500 ms at baseline

16. 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

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 of the study

18. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, 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 study or unlikely to comply with all study procedures and treatment