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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome

Secondary outcome measures

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 more

Trial 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 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inversago Pharma Inc.Lead Sponsor

3 Previous Clinical Trials

317 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an upper age limit of 75 years?

"The criteria for participation in this study stipulates that the minimum age of enrolment is 18, while the maximum should be no more than 75."

Answered by AI

Are there any available slots for volunteers to participate in this experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is currently enrolling participants, and the research was initiated on September 8th 2023 before being updated on September 20th 2023. The study aims to collect data from 240 patients at 24 different sites."

Answered by AI

How widely dispersed are the sites conducting this experiment?

"Patients are currently being recruited from 24 different clinical trial sites, including Centricity Research -New Minas in New Minas, Aggarwal and Associates Limited in Brampton, and Wharton Medical Clinic (WMC) - Toronto in Hamilton."

Answered by AI

How hazardous is Middle Dose to individuals?

"The estimated safety of Middle Dose is rated a 2, as data suggests potential effectiveness has yet to be confirmed and only early assurance regarding its security."

Answered by AI

What is the maximum capacity of participants in this experiment?

"Affirmative. According to information on the clinicaltrials.gov website, this research project is presently enrolling patients. It was initiated by investigators on September 8th 2023 and recently updated on September 20th 2023; they seek a total of 240 participants from 24 sites across America."

Answered by AI

Could I partake in this experiment?

"This clinical study is recruiting two-hundred and forty individuals who have been diagnosed with obesity, whose ages are between 18 and 75. To be eligible for enrolment, participants must meet the following criteria: 1. Male or female aged between 18 to 75 years old 2. Capable of providing informed consent in addition to adhering to all hospital visits and procedures related to this trial 3. Having a BMI that surpasses 30 kg/m2 4. Demonstrating at least three out of five conditions including an elevated waist circumference (men = 40 inches; women = 35 inches), glucose levels above 100 mg/dL within the"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of INV-202 in Patients With Obesity and Metabolic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05891834.

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