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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Drug: INV-202; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Glenn Crater; Phone Number: 919-371-8411; Email: clinicalstrials-inquiries@inversago.com
• Study Contact Backup: Name: Karine Lalonde; Phone Number: 438-300-2550; Email: clinicalstrials-inquiries@inversago.com

Study Locations

• Canada
  • British Colombia
    • New Westminster, British Colombia, Canada, V3L 3W5
      • Office of David H. Shu, MD
  • Nova Scotia
    • New Minas, Nova Scotia, Canada, B4N 3R7
      • Centricity Research -New Minas
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates, Limited
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Medical Clinic (WMC) - Toronto
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research Inc
    • Oshawa, Ontario, Canada, L1J 2K9
      • Centricity Research - Oshawa
    • Sarnia, Ontario, Canada, N7t 4X3
      • Bluewater Clinical Research Group Inc
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K. Gupta Medicine Professional Corporation
    • Toronto, Ontario, Canada, M3J 0K2
      • Canadian Phase Onward Inc.
    • Waterloo, Ontario, Canada, N2J 1C4
      • Dr. Sameh Fikry Medicine Professional Corporation
    • Waterloo, Ontario, Canada, N2T 0C1
      • Clinical Research Solutions
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Joliette, Quebec, Canada, J6E 2B4
      • DIEX Research Joliette
    • Lévis, Quebec, Canada, G6W OM5
      • Centricity Research - Levis
    • Mirabel, Quebec, Canada, J7J 2K8
      • Centricity Research - Mirabel
    • Montréal, Quebec, Canada, H4N 2W2
      • 9109-0126 Quebec Inc
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Centricity Research - Pointe-Claire
    • Québec, Quebec, Canada, G1N 4V3
      • DIEX Research Quebec
    • Québec, Quebec, Canada, G1V 4W2
      • Centre des maladies lipidique deq Quebec, CMLQ Inc.
    • Québec, Quebec, Canada, G2J 0C4
      • Alpha Recherche Clinique - Lebourgneuf
    • Québec, Quebec, Canada, G3K 2P8
      • Alpha Recherche Clinique Val-Bélair
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke
    • Trois-Rivières, Quebec, Canada, N5W 6A2
      • Diex Recherche Trois-Rivieres
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriaville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose; INV-202, 10 mg	Drug: INV-202; tablet, once daily, oral
Placebo Comparator: Placebo; Placebo Matching size and number of tablets	Drug: Placebo; tablet, once daily, oral
Experimental: High dose; INV-202, 50 mg	Drug: INV-202; tablet, once daily, oral
Experimental: Middle Dose; INV-202, 20 mg	Drug: INV-202; tablet, once daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Inversago Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome
• Other Study ID Numbers: INV-CL-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No