INV-202 for Obesity and Metabolic Syndrome

Recruiting at 23 trial locations

Overseen By Karine Lalonde

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inversago Pharma Inc.

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Substance abuse, Diabetes, Psychiatric disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

243 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Inclusion Criteria

You have a body mass index (BMI) of 30 or higher.

Able and willing to provide informed consent and to comply with scheduled visits and study procedures

I meet at least 3 of the criteria for metabolic syndrome.

Exclusion Criteria

You have a current or past serious mental health condition.

My medications for blood pressure, cholesterol, or blood sugar have been stable for the last 3 months.

I am not taking medication that strongly affects certain liver enzymes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person), with possible retest

Treatment

Participants receive INV-202 or placebo with assessments at Weeks 4, 8, 12, and 16

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue receiving INV-202 for further evaluation of efficacy and safety

36 weeks

Regular visits (in-person)

Treatment Details

Interventions

• INV-202

Trial Overview 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.

Participant Groups

Group I: Middle Dose Experimental Treatment 1 Intervention

INV-202, 20 mg

Group II: Low dose Experimental Treatment 1 Intervention

INV-202, 10 mg

Group III: High dose Experimental Treatment 1 Intervention

INV-202, 50 mg

Group IV: Placebo Placebo Group 2 Interventions

Placebo Matching size and number of tablets

Who Is Running the Clinical Trial?

Inversago Pharma Inc.

Lead Sponsor

Trials

4

Recruited

590+