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

NCT ID: NCT05891834

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2025-02-14

Brief Summary

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.

Detailed Description

This will be a 2-part study. Part A will be a randomized, double-blind, placebo-controlled, dose ranging, multicenter study assessing the efficacy, safety, tolerability, and PK of INV-202 for the treatment of adult participants with obesity (BMI 30 kg/m2) and metabolic syndrome.

An informed consent form (ICF) must be signed by the participant before any study-related procedures are performed.

Each participant will be allowed 1 retest during the screening period if they have an abnormal test result not meeting eligibility criteria that is deemed transient by the investigator. Participants who did not meet all eligibility criteria may be re-screened once, with approval of the medical monitor.

Participants will return to the study site at Weeks 4, 8, 12 and 16. At these visits, the same assessment as baseline will be completed.

During Part A, a subset of approximately 20 to 30 participants from an estimated 3 to 4 study sites will have DEXA performed at baseline and Week 16 for exploratory assessments of change in total body fat percentage and skeletal muscle mass. Additional exploratory measures will include lung function with oscillometry. Any participant who withdraws from Part A before completing treatment will be requested to return for an early termination visit, at which time the procedures normally scheduled for the Week 16 visit will be conducted.

Participants completing Part A will be eligible to enroll to the open-label extension (OLE), Part B, if they did not have significant noncompliance with study drug, visits, or procedures, and did not meet any withdrawal criteria. During Part B, the efficacy and safety of INV-202 20 mg daily (pending results of chronic toxicology studies and/or findings from this and other ongoing clinical studies, the alternative dose would be 10 mg) will be further evaluated over an additional 36 weeks, through Week 52.

Conditions

Obesity; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose

INV-202, 10 mg

Group Type: EXPERIMENTAL

INV-202

Intervention Type: DRUG

tablet, once daily, oral

High dose

INV-202, 50 mg

Group Type: EXPERIMENTAL

INV-202

Intervention Type: DRUG

tablet, once daily, oral

Placebo

Placebo Matching size and number of tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

tablet, once daily, oral

Middle Dose

INV-202, 20 mg

Group Type: EXPERIMENTAL

INV-202

Intervention Type: DRUG

tablet, once daily, oral

Interventions

INV-202

tablet, once daily, oral

Intervention Type: DRUG

Placebo

tablet, once daily, oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female participants from 18 to 75 years of age 2. Able and willing to provide informed consent and to comply with scheduled visits and study procedures 3. BMI ≥ 30 kg/m2 4. 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

Exclusion Criteria

1. 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

2. Active substance abuse including inhaled, oral, or injection drugs in the past 12 months

3. Use of cannabis or cannabinoid-containing compounds within 90 days prior to screening

4. Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study

5. History of significant liver disease or evidence of moderate to severe hepatic impairment

6. History of epilepsy or intracranial surgery

7. Diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary)

8. 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

9. Participants 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)

10. Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded)

11. Participants with 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

12. Score on the 9-question Patient Health Questionnaire (PHQ-9) of

13. 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

14. A history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection

15. QTc > 500 ms at baseline

16. 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

17. Participants taking 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

18. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit

19. Previous use of INV-202

20. Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inversago Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Office of David H. Shu, MD

New Westminster, British Colombia, Canada

Centricity Research -New Minas

New Minas, Nova Scotia, Canada

Aggarwal and Associates, Limited

Brampton, Ontario, Canada

Wharton Medical Clinic (WMC) - Toronto

Hamilton, Ontario, Canada

Milestone Research Inc

London, Ontario, Canada

Centricity Research - Oshawa

Oshawa, Ontario, Canada

Bluewater Clinical Research Group Inc

Sarnia, Ontario, Canada

Canadian Phase Onward Inc.

Toronto, Ontario, Canada

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

Dr. Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, Canada

Clinical Research Solutions

Waterloo, Ontario, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

DIEX Research Joliette

Joliette, Quebec, Canada

Centricity Research - Levis

Lévis, Quebec, Canada

Centricity Research - Mirabel

Mirabel, Quebec, Canada

9109-0126 Quebec Inc

Montreal, Quebec, Canada

Centricity Research - Pointe-Claire

Pointe-Claire, Quebec, Canada

DIEX Research Quebec

Québec, Quebec, Canada

Centre des maladies lipidique deq Quebec, CMLQ Inc.

Québec, Quebec, Canada

Alpha Recherche Clinique - Lebourgneuf

Québec, Quebec, Canada

Alpha Recherche Clinique Val-Bélair

Québec, Quebec, Canada

Diex Recherche Sherbrooke

Sherbrooke, Quebec, Canada

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, Canada

Diex Recherche Victoriaville

Victoriaville, Quebec, Canada

Countries

Canada

References

Knop FK, Kunos G, Dicker D, Paquette JS, Aronne L, Frenkel O, Holst-Hansen T, Lalonde K, Lee J, Crater G; trial investigators. Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial. Lancet Diabetes Endocrinol. 2025 Sep 29:S2213-8587(25)00216-5. doi: 10.1016/S2213-8587(25)00216-5. Online ahead of print.

Reference Type: DERIVED

PMID: 41038215 (View on PubMed)

Other Identifiers

INV-CL-107

Identifier Type: -

Identifier Source: org_study_id