ObesityPhase 2NCT05891834
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
A Phase 2 study testing INV-202 in people with Obesity and Metabolic Syndrome, run by Inversago Pharma Inc. at 24 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- INV-202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 24 sitesCanada
- Study dates
- 8 Sep 2023to 14 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Canada24 sites
Aggarwal and Associates, Limited
Brampton, Ontario, L6T 0G1
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
Wharton Medical Clinic (WMC) - Toronto
Hamilton, Ontario, L8L 5G8
DIEX Research Joliette
Joliette, Quebec, J6E 2B4
Centricity Research - Levis
Lévis, Quebec, G6W OM5
Milestone Research Inc
London, Ontario, N5W 6A2
Centricity Research - Mirabel
Mirabel, Quebec, J7J 2K8
9109-0126 Quebec Inc
Montreal, Quebec, H4N 2W2
Centricity Research -New Minas
New Minas, Nova Scotia, B4N 3R7
Office of David H. Shu, MD
New Westminster, British Colombia, V3L 3W5
Centricity Research - Oshawa
Oshawa, Ontario, L1J 2K9
Centricity Research - Pointe-Claire
Pointe-Claire, Quebec, H9R 4S3
DIEX Research Quebec
Québec, Quebec, G1N 4V3
Centre des maladies lipidique deq Quebec, CMLQ Inc.
Québec, Quebec, G1V 4W2
Alpha Recherche Clinique - Lebourgneuf
Québec, Quebec, G2J 0C4
Alpha Recherche Clinique Val-Bélair
Québec, Quebec, G3K 2P8
Bluewater Clinical Research Group Inc
Sarnia, Ontario, N7T 4X3
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, N5W 6A2
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 6P6
Dr. Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, N2J 1C4
Clinical Research Solutions
Waterloo, Ontario, N2T 0C1
About this study
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
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.
Read the 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
- Being tested
- INV-202, Placebo
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-202Drug
tablet, once daily, oral
PlaceboDrug
tablet, once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | INV-202, 10 mg Receives: Drug: INV-202 |
| High dose | Experimental | INV-202, 50 mg Receives: Drug: INV-202 |
| Placebo | Placebo comparator | Placebo Matching size and number of tablets Receives: Drug: Placebo |
| Middle Dose | Experimental | INV-202, 20 mg Receives: Drug: INV-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 16
Secondary outcomes (6)
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
Measured: Week 16
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start8 Sep 2023
- Primary completion13 Jun 2024
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inversago Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891834
- Sponsor's protocol ID
- INV-CL-107
- Status last verified
- Jun 2025
- First submitted
- 17 May 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41038215
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05891834
- Acronym / sponsor ID
- INV-CL-107
- Conditions
- Obesity, Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Inversago Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: INV-202INV-202, 10 mg |
| High dose | Experimental | Drug: INV-202INV-202, 50 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Matching size and number of tablets |
| Middle Dose | Experimental | Drug: INV-202INV-202, 20 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INV-202tablet, once daily, oral | Drug | High dose, Low dose, Middle Dose |
| Placebotablet, once daily, oral | Drug | Placebo |
Primary outcome
To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome
Time frame: Week 16
Mean change from baseline in body weight at Week 16 for INV-202 versus placebo
6 secondary outcomes
To evaluate the effect of INV-202 on weight (marker of metabolic syndrome)
Time frame: Week 16
To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome)
Time frame: Week 16
To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome)
Time frame: Week 16
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
Time frame: Week 16
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
Time frame: Week 16
To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 41038215Knop 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INV-202 in people with Obesity and Metabolic Syndrome, run by Inversago Pharma Inc. at 24 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.