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Monlunabant in Obesity and Metabolic Syndrome
NCT05891834Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2023
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- Inversago
- Modality
- Small Molecules
- Drugs
- monlunabant
- Conditions
- obesitymetabolic syndrome
01
Overview
Phase 2, randomised, double-blind trial of monlunabant in obesity and metabolic syndrome (4 arms), sponsored by Inversago. Primary endpoint: Body weight loss at 16 weeks. Started Sep 2023; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Low dose
INV-202 10 mg daily
Middle Dose
INV-202 20 mg daily
High dose
INV-202 50 mg daily
Placebo
Matching placebo daily
03
Who it enrols
Adults aged 18-75 with BMI >= 30 kg/m2 and metabolic syndrome (3 of 5 criteria: waist circumference, fasting glucose/HgbA1C, triglycerides, HDL, hypertension). Excludes patients with diabetes requiring medication, history of bariatric surgery or significant weight change, use of weight loss drugs (including GLP-1s), significant psychiatric disorders, or QTc > 500 ms.
04
Endpoints
Primary
Body weight loss
Secondary
Weight
Waist circumference
Lipid profile
Glucose control parameters
05
Results
Primary endpoints met
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