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INV-202

Phase 2

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jun 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment243
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05891834Study of INV-202 in Patients With Obesity and Metabolic SyndromePHASE2 COMPLETED 243Sep 8, 2023Feb 14, 2025Jun 5, 202524 Canada
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Study Endpoints
Primary Endpoints
To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome
Week 16

Mean change from baseline in body weight at Week 16 for INV-202 versus placebo

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low doseEXPERIMENTALINV-202, 10 mg
High doseEXPERIMENTALINV-202, 50 mg
PlaceboPLACEBO_COMPARATORPlacebo Matching size and number of tablets
Middle DoseEXPERIMENTALINV-202, 20 mg
Interventions
NameTypeDescription
INV-202DRUGtablet, once daily, oral
PlaceboDRUGtablet, once daily, oral
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

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 circumfer...

Countries:Canada
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