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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05891834
Other study ID # INV-CL-107
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 8, 2023
Est. completion date March 1, 2025

Study information

Verified date May 2024
Source Inversago Pharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 243
Est. completion date March 1, 2025
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
INV-202
tablet, once daily, oral
Placebo
tablet, once daily, oral

Locations

Country Name City State
Canada Aggarwal and Associates, Limited Brampton Ontario
Canada Ecogene-21 Chicoutimi Quebec
Canada Wharton Medical Clinic (WMC) - Toronto Hamilton Ontario
Canada DIEX Research Joliette Joliette Quebec
Canada Centricity Research - Levis Lévis Quebec
Canada Milestone Research Inc London Ontario
Canada Centricity Research - Mirabel Mirabel Quebec
Canada 9109-0126 Quebec Inc Montréal Quebec
Canada Centricity Research -New Minas New Minas Nova Scotia
Canada Office of David H. Shu, MD New Westminster British Colombia
Canada Centricity Research - Oshawa Oshawa Ontario
Canada Centricity Research - Pointe-Claire Pointe-Claire Quebec
Canada Alpha Recherche Clinique - Lebourgneuf Québec Quebec
Canada Alpha Recherche Clinique Val-Bélair Québec Quebec
Canada Centre des maladies lipidique deq Quebec, CMLQ Inc. Québec Quebec
Canada DIEX Research Quebec Québec Quebec
Canada Bluewater Clinical Research Group Inc Sarnia Ontario
Canada Diex Recherche Sherbrooke Sherbrooke Quebec
Canada Canadian Phase Onward Inc. Toronto Ontario
Canada Dr. Anil K. Gupta Medicine Professional Corporation Toronto Ontario
Canada Diex Recherche Trois-Rivieres Trois-Rivières Quebec
Canada Diex Recherche Victoriaville Victoriaville Quebec
Canada Clinical Research Solutions Waterloo Ontario
Canada Dr. Sameh Fikry Medicine Professional Corporation Waterloo Ontario

Sponsors (1)

Lead Sponsor Collaborator
Inversago Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome Mean change from baseline in body weight at Week 16 for INV-202 versus placebo Week 16
Secondary To evaluate the effect of INV-202 on weight (marker of metabolic syndrome) Mean percent change from baseline at each site visit for the following:
Percent change in weight
Week 16
Secondary To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome) Mean change from baseline at each site visit for the following:
Change in waist circumference
Week 16
Secondary To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome) Mean change from baseline at each site visit for the following:
Change in lipids (LDL, VLDL, HDL, total cholesterol, ApoB) results by central laboratory testing
Week 16
Secondary To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome) Mean change from baseline at each site visit for the following:
Change in markers of glucose control (HgbA1C) results by central laboratory testing
Week 16
Secondary To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome) Mean change from baseline at each site visit for the following:
Change in markers of glucose control (insulin) results by central laboratory testing
Week 16
Secondary To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome) Mean change from baseline at each site visit for the following:
Change in markers of glucose control (C-peptide) results by central laboratory testing
Week 16
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