INV-202 for Obesity and Metabolic Syndrome

No longer recruiting at 24 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial is studying an experimental drug called INV-202 to determine its effectiveness in treating obesity and metabolic syndrome. Researchers aim to assess the drug's safety and efficacy in the body. Participants will receive either a low, middle, or high dose of INV-202, or a placebo (a non-active pill that looks the same). The trial seeks adults with obesity who also have conditions such as high blood pressure, high blood sugar, or high cholesterol. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial requires you to stop certain medications, especially those used for weight loss, diabetes management, and some psychiatric conditions. If you're taking drugs that affect blood pressure, lipids, or blood glucose, they should not have been started or changed in the past 3 months. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that INV-202 is likely to be safe for humans?

Research has shown that INV-202 has promising safety results from earlier studies. Most participants in these studies tolerated INV-202 well. One study found that participants lost weight quickly and showed improvements in metabolic health, indicating the drug worked well without major issues. Another study confirmed that INV-202 did not cause serious side effects, and participants also lost a significant amount of weight in a short time. These findings suggest that INV-202 is both effective and safe for treating obesity and metabolic syndrome. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity and metabolic syndrome?

Unlike the standard treatments for obesity and metabolic syndrome, which often include lifestyle changes, medications like orlistat, or hormone-based therapies, INV-202 offers a novel approach. INV-202 is particularly exciting because it targets the condition with a new mechanism of action, potentially providing a more direct method of addressing the underlying metabolic issues. Researchers are intrigued by its potential to offer improved efficacy and safety over existing options, making weight management and metabolic health more achievable for patients.

What evidence suggests that INV-202 might be an effective treatment for obesity and metabolic syndrome?

Research has shown that INV-202 could benefit people with obesity and metabolic syndrome. Early studies found it safe and led to noticeable weight loss quickly, sometimes in just 28 days. Participants also experienced improvements in factors related to heart disease and diabetes. INV-202 works by blocking CB1 receptors, which affect appetite and metabolism. This action aids weight loss and improves other health measures. Overall, the early results are promising for INV-202's potential to address obesity and related health issues. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15353

Effects of CB1R inverse agonist, INV‐202, in patients with ... INV-202 was well tolerated, producing a signal for rapid weight loss with improvements in other metabolic syndrome markers in this population.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05891834

NCT05891834 | Study of INV-202 in Patients With Obesity ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37941317/

Effects of CB1R inverse agonist, INV-202, in patients with ... INV-202 was well tolerated, producing a signal for rapid weight loss with improvements in other metabolic syndrome markers in this population.

4. inversago.com inversago.com/en/2023/inversago-pharma-presents-data-from-phase-1b-trial-of-inv-202-a-peripheral-cb1r-blocker-for-metabolic-syndrome-at-the-83rd-american-diabetes-association-scientific-sessions/

Inversago Pharma Presents Data from Phase 1b Trial of ... -Study results demonstrated favorable safety, tolerability, and PK profile -Clinically significant weight loss was observed in only 28 days

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05891834/study-of-inv-202-in-patients-with-obesity-and-metabolic-syndrome

Study of INV-202 in Patients With Obesity and Metabolic ... The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/inversago-metabolic-syndrome-trial/

Inversago begins dosing with INV-202 in Phase Ib ... The trial will analyse the safety profile and pharmacokinetics of INV-202 in 40 subjects with metabolic syndrome. Topline data from the trial is ...