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NCT05891834 (INV-202 in Obesity and Metabolic Syndrome): BVCT ex-ante prediction vs. reported outcome

On 17 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 20 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to tirzepatide in both efficacy and toxicity).

Clinical Trial

NCTID
NCT05891834
Drug Name
INV-202 (Monlunabant)
Drug MoA
peripherally selective beta-arrestin-2-biased CB1 inverse agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Obesity and Metabolic Syndrome
Human Patients
243
Sponsor
Novo Nordisk
Phase
Phase 2

Prediction of , index 1682

Prospective Prediction
Prediction Index
1682
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in weight reduction and adverse effect both inferior to semaglutide)
Technical Prediction
partial SUCCESS (statistically significant yet weak clinical benefit in weight reduction against placebo with moderate toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
65 days in advance
Readout Data Interpretation
monlunabant achieved 5.8% placebo-adjusted weight reduction in week 16; inferior to tirzepatide 9% placebo-adjusted weight reduction in week 16 (see 10.1056/NEJMoa2206038); Reporting mild-to-moderate psychiatric side effects in additional to typical GI adverse effects.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to tirzepatide in both efficacy and toxicity)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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
Phase
Phase 2
Status
Completed
Enrollment
243
Lead sponsor
Inversago Pharma Inc.
Conditions
Obesity; Metabolic Syndrome
Interventions
DRUG: INV-202; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-09-08
Primary completion
2024-06-13
Completion
2025-02-14
Primary outcomes
  • To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome (Week 16)

NCT05891834 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials