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

NCT05891834 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: INV-CL-107
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 24

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.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To evaluate the effect of INV-202 on weight (marker of metabolic syndrome)

  Week 16

• To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome)

  Week 16

• To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome)

  Week 16

• To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)

  Week 16

• To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)

  Week 16

Study Arms (4)

Low dose

EXPERIMENTAL

INV-202, 10 mg

Drug: INV-202

High dose

EXPERIMENTAL

INV-202, 50 mg

Drug: INV-202

Placebo

PLACEBO COMPARATOR

Placebo Matching size and number of tablets

Drug: Placebo

Middle Dose

EXPERIMENTAL

INV-202, 20 mg

Drug: INV-202

Interventions

INV-202 DRUG

tablet, once daily, oral

High dose; Low dose; Middle Dose

Placebo DRUG

tablet, once daily, oral

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Inversago Pharma Inc.: lead

Study Sites (24)

Office of David H. Shu, MD

New Westminster, British Colombia, V3L 3W5, Canada

Location

Centricity Research -New Minas

New Minas, Nova Scotia, B4N 3R7, Canada

Location

Aggarwal and Associates, Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Wharton Medical Clinic (WMC) - Toronto

Hamilton, Ontario, L8L 5G8, Canada

Location

Milestone Research Inc

London, Ontario, N5W 6A2, Canada

Location

Centricity Research - Oshawa

Oshawa, Ontario, L1J 2K9, Canada

Location

Bluewater Clinical Research Group Inc

Sarnia, Ontario, N7T 4X3, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3J 0K2, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

Dr. Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, N2J 1C4, Canada

Location

Clinical Research Solutions

Waterloo, Ontario, N2T 0C1, Canada

Location

Ecogene-21

Chicoutimi, Quebec, G7H 7K9, Canada

Location

DIEX Research Joliette

Joliette, Quebec, J6E 2B4, Canada

Location

Centricity Research - Levis

Lévis, Quebec, G6W OM5, Canada

Location

Centricity Research - Mirabel

Mirabel, Quebec, J7J 2K8, Canada

Location

9109-0126 Quebec Inc

Montreal, Quebec, H4N 2W2, Canada

Location

Centricity Research - Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

DIEX Research Quebec

Québec, Quebec, G1N 4V3, Canada

Location

Centre des maladies lipidique deq Quebec, CMLQ Inc.

Québec, Quebec, G1V 4W2, Canada

Location

Alpha Recherche Clinique - Lebourgneuf

Québec, Quebec, G2J 0C4, Canada

Location

Alpha Recherche Clinique Val-Bélair

Québec, Quebec, G3K 2P8, Canada

Location

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, N5W 6A2, Canada

Location

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 6P6, Canada

Location

Related Publications (1)

• 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 Nov;13(11):911-923. doi: 10.1016/S2213-8587(25)00216-5. Epub 2025 Sep 29.

  PMID: 41038215 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 7, 2023
• Study Start: September 8, 2023
• Primary Completion: June 13, 2024
• Study Completion: February 14, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (24)