Are you Struggling With Obesity, or Being Overweight?
This clinical research study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202; an investigational drug for the treatment of adult participants with obesity or metabolic syndrome.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with obesity, and whether it will be made widely available to all Canadians trying to manage obesity. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are male or female participants from 18 to 75 years of age
- Are able and willing to provide informed consent and to comply with scheduled visits and study procedures
- BMI ≥ 30 kg/m2
- Have the 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
You may not qualify to participate if you:
- Have any 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
- Participate in any active substance abuse including inhaled, oral, or injection drugs in the past 12 months
- Use cannabis or cannabinoid-containing compounds within 90 days prior to screening
- Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study
- Have a history of significant liver disease or evidence of moderate to severe hepatic impairment
- Have a history of epilepsy or intracranial surgery
- Have diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary)
- Have had 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
- Are 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 systemic corticosteroids (topical and inhaled corticosteroids are not excluded)
- Have 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
- Have had a 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
- Have a history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection
- Have QTc > 500 ms at baseline
- Take 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
- Take 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
- Have taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit
- Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.