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INV-202 for Obesity and Metabolic Syndrome
Phase 2
Waitlist Available
Research Sponsored by Inversago Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
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
Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6, or 2C19 by screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Summary
This trial will test if an investigational drug is safe and effective at treating obesity and metabolic syndrome in adult participants.
Who is the study for?
Adults aged 18-75 with obesity (BMI ≥ 30) and metabolic syndrome, having at least three of these: large waist size, high fasting glucose or HgbA1C, abnormal triglycerides or HDL levels, hypertension. Must not have had significant weight changes recently, be on certain medications including weight-loss drugs or have serious health issues like liver disease, epilepsy, active substance abuse, severe psychiatric disorders.
What is being tested?
The trial is testing INV-202 against a placebo to see if it's effective and safe for treating obesity and metabolic syndrome. Participants will either receive the investigational drug INV-202 or a placebo without knowing which one they are getting.
What are the potential side effects?
While specific side effects of INV-202 aren't listed here, common ones in trials for new obesity/metabolic treatments may include gastrointestinal discomforts such as nausea or diarrhea; headaches; fatigue; potential allergic reactions; and possibly effects on heart rate/blood pressure.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My medications for blood pressure, cholesterol, or blood sugar have been stable for the last 3 months.
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I am not taking medication that strongly affects certain liver enzymes.
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I have a history of thyroid disease.
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I am currently taking medication for weight loss.
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I haven't had any cancer except for skin cancer or in situ cancer in the last 5 years.
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I am currently taking corticosteroids.
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I have previously used INV-202.
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I haven't had weight loss surgery, used weight loss drugs, or lost more than 11 pounds in the last 3 months.
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I have had epilepsy or brain surgery.
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I have a history of serious liver disease or severe liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome
Secondary study objectives
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome)
To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome)
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Middle DoseExperimental Treatment1 Intervention
INV-202, 20 mg
Group II: Low doseExperimental Treatment1 Intervention
INV-202, 10 mg
Group III: High doseExperimental Treatment1 Intervention
INV-202, 50 mg
Group IV: PlaceboPlacebo Group2 Interventions
Placebo Matching size and number of tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INV-202
2022
Completed Phase 2
~310
Find a Location
Who is running the clinical trial?
Inversago Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
342 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
37 Patients Enrolled for Metabolic Syndrome