search
Back to results

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

Primary Purpose

Obesity, Metabolic Syndrome

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
INV-202
Placebo
Sponsored by
Inversago Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 Active substance abuse including inhaled, oral, or injection drugs in the past 12 months Use of cannabis or cannabinoid-containing compounds within 90 days prior to screening Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study History of significant liver disease or evidence of moderate to severe hepatic impairment History of epilepsy or intracranial surgery Diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary) 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 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) Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded) 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 Score on the 9-question Patient Health Questionnaire (PHQ-9) of 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 A history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection QTc > 500 ms at baseline 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 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 Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit Previous use of INV-202 Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment

Sites / Locations

  • Office of David H. Shu, MDRecruiting
  • Centricity Research -New MinasRecruiting
  • Aggarwal and Associates, LimitedRecruiting
  • Wharton Medical Clinic (WMC) - TorontoRecruiting
  • Milestone Research IncRecruiting
  • Centricity Research - OshawaRecruiting
  • Bluewater Clinical Research Group IncRecruiting
  • Canadian Phase Onward Inc.Recruiting
  • Dr. Anil K. Gupta Medicine Professional CorporationRecruiting
  • Dr. Sameh Fikry Medicine Professional CorporationRecruiting
  • Clinical Research SolutionsRecruiting
  • Ecogene-21Recruiting
  • DIEX Research JolietteRecruiting
  • Centricity Research - LevisRecruiting
  • Centricity Research - MirabelRecruiting
  • 9109-0126 Quebec IncRecruiting
  • Centricity Research - Pointe-ClaireRecruiting
  • DIEX Research QuebecRecruiting
  • Centre des maladies lipidique deq Quebec, CMLQ Inc.Recruiting
  • Alpha Recherche Clinique - LebourgneufRecruiting
  • Alpha Recherche Clinique Val-BélairRecruiting
  • Diex Recherche SherbrookeRecruiting
  • Diex Recherche Trois-RivieresRecruiting
  • Diex Recherche VictoriavilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Low dose

High dose

Placebo

Middle Dose

Arm Description

INV-202, 10 mg

INV-202, 50 mg

Placebo Matching size and number of tablets

INV-202, 20 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
May 17, 2023
Last Updated
September 27, 2023
Sponsor
Inversago Pharma Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05891834
Brief Title
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of 3 Doses of INV-202 With an Optional Open-Label Extension in Patients With Obesity and Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inversago Pharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
INV-202, 10 mg
Arm Title
High dose
Arm Type
Experimental
Arm Description
INV-202, 50 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Matching size and number of tablets
Arm Title
Middle Dose
Arm Type
Experimental
Arm Description
INV-202, 20 mg
Intervention Type
Drug
Intervention Name(s)
INV-202
Intervention Description
tablet, once daily, oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, once daily, oral
Primary Outcome Measure Information:
Title
To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome
Description
Mean change from baseline in body weight at Week 16 for INV-202 versus placebo
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
To evaluate the effect of INV-202 on weight (marker of metabolic syndrome)
Description
Mean percent change from baseline at each site visit for the following: Percent change in weight
Time Frame
Week 16
Title
To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome)
Description
Mean change from baseline at each site visit for the following: Change in waist circumference
Time Frame
Week 16
Title
To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome)
Description
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
Time Frame
Week 16
Title
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
Description
Mean change from baseline at each site visit for the following: Change in markers of glucose control (HgbA1C) results by central laboratory testing
Time Frame
Week 16
Title
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
Description
Mean change from baseline at each site visit for the following: Change in markers of glucose control (insulin) results by central laboratory testing
Time Frame
Week 16
Title
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
Description
Mean change from baseline at each site visit for the following: Change in markers of glucose control (C-peptide) results by central laboratory testing
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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 Active substance abuse including inhaled, oral, or injection drugs in the past 12 months Use of cannabis or cannabinoid-containing compounds within 90 days prior to screening Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study History of significant liver disease or evidence of moderate to severe hepatic impairment History of epilepsy or intracranial surgery Diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary) 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 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) Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded) 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 Score on the 9-question Patient Health Questionnaire (PHQ-9) of 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 A history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection QTc > 500 ms at baseline 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 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 Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit Previous use of INV-202 Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glenn Crater
Phone
919-371-8411
Email
clinicalstrials-inquiries@inversago.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karine Lalonde
Phone
438-300-2550
Email
clinicalstrials-inquiries@inversago.com
Facility Information:
Facility Name
Office of David H. Shu, MD
City
New Westminster
State/Province
British Colombia
ZIP/Postal Code
V3L 3W5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Shu
First Name & Middle Initial & Last Name & Degree
David Shu
Facility Name
Centricity Research -New Minas
City
New Minas
State/Province
Nova Scotia
ZIP/Postal Code
B4N 3R7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mindrum
First Name & Middle Initial & Last Name & Degree
Michael Mindrum
Facility Name
Aggarwal and Associates, Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naresh Aggarwal
First Name & Middle Initial & Last Name & Degree
Naresh Aggarwal
Facility Name
Wharton Medical Clinic (WMC) - Toronto
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Wharton
First Name & Middle Initial & Last Name & Degree
Sean Wharton
Facility Name
Milestone Research Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Dzongowski
First Name & Middle Initial & Last Name & Degree
Peter Dzongowski
Facility Name
Centricity Research - Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Handa Rishi
First Name & Middle Initial & Last Name & Degree
Handa Rishi
Facility Name
Bluewater Clinical Research Group Inc
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Peterson
First Name & Middle Initial & Last Name & Degree
Sean Peterson
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 0K2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lew Pliamm
First Name & Middle Initial & Last Name & Degree
Lew Pliamm
Facility Name
Dr. Anil K. Gupta Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Gupta
First Name & Middle Initial & Last Name & Degree
Anil Gupta
Facility Name
Dr. Sameh Fikry Medicine Professional Corporation
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadia El Boreky
First Name & Middle Initial & Last Name & Degree
Fadia El Boreky
Facility Name
Clinical Research Solutions
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2T 0C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivinder Jolly
First Name & Middle Initial & Last Name & Degree
Shivinder Jolly
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gaudet
First Name & Middle Initial & Last Name & Degree
Daniel Gaudet
Facility Name
DIEX Research Joliette
City
Joliette
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Sebastien Paquette
First Name & Middle Initial & Last Name & Degree
Jean-Sebastien Paquette
Facility Name
Centricity Research - Levis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6W OM5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Vallieres
First Name & Middle Initial & Last Name & Degree
Gerald Vallieres
Facility Name
Centricity Research - Mirabel
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Tellier
First Name & Middle Initial & Last Name & Degree
Guy Tellier
Facility Name
9109-0126 Quebec Inc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Akhras
First Name & Middle Initial & Last Name & Degree
Ronald Akhras
Facility Name
Centricity Research - Pointe-Claire
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveen Garg
First Name & Middle Initial & Last Name & Degree
Naveen Garg
Facility Name
DIEX Research Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Rheaume
First Name & Middle Initial & Last Name & Degree
Caroline Rheaume
Facility Name
Centre des maladies lipidique deq Quebec, CMLQ Inc.
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Weisnagel
First Name & Middle Initial & Last Name & Degree
John Weisnagel
Facility Name
Alpha Recherche Clinique - Lebourgneuf
City
Québec
State/Province
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Naccache
First Name & Middle Initial & Last Name & Degree
Maya Naccache
Facility Name
Alpha Recherche Clinique Val-Bélair
City
Québec
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Walsh
First Name & Middle Initial & Last Name & Degree
Camille Walsh
Facility Name
Diex Recherche Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ginette Girard
First Name & Middle Initial & Last Name & Degree
Ginette Girard
Facility Name
Diex Recherche Trois-Rivieres
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
N5W 6A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen Tanfous
First Name & Middle Initial & Last Name & Degree
Mohsen Tanfous
Facility Name
Diex Recherche Victoriaville
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethel Bellavance
First Name & Middle Initial & Last Name & Degree
Ethel Bellavance

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs