Effects of CB1R inverse agonist, INV ‐202, in patients with features of metabolic syndrome. A randomized, placebo‐controlled, double‐blind phase 1b study
Authors' conclusion
INV-202 was well tolerated, producing a signal for rapid weight loss with improvements in other metabolic syndrome markers in this population. These findings support further exploration and long-term assessment of cardiometabolic effects.
Study context
- Population
- Adults aged 18 to 65 years with features of metabolic syndrome and glucose intolerance (46% female, mean age 55 years, HbA1c 5.7% [39 mmol/mol], BMI 38.1 kg/m²)
- Participants
- 37 adults
- Comparison
- INV-202 25 mg once daily vs placebo
- Primary endpoint
- Clinical safety, tolerability, pharmacokinetic and pharmacodynamic profile
- Follow-up
- 28 days
Methodological detailsmulticentre, double-blind, placebo-controlled, parallel-group, phase 1b, 28-day repeat-dose, post hoc statistical comparisons
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel-group
- Phase 1b
- 28-day repeat-dose
- Post hoc statistical comparisons
Primary result
As reported in the abstract
Safety and tolerability
- INV-202 well tolerated; no serious or severe treatment-emergent adverse events
- Most common events related to known effects of CB1R blockade in the gastrointestinal tract
Further findings
OGTT 0- to 3-hour AUC · no significant difference
ratio 97.1% (90.2–105.6) · P = 0.43
| Outcome | INV-202 | Placebo |
|---|---|---|
| Weight changePost hoc comparison | mean 3.5 kg weight loss (3.3%) | mean 0.6 kg weight gain (0.5%) |
- Waist circumference and BMI · significant reductions with INV-202
- P ≤ 0.03
Weight change
- Significant weight loss with INV-202 vs placebo
Safety
- No serious or severe treatment-emergent adverse events with INV-202; most common events gastrointestinal, related to CB1R blockade
Original publication
Effects of CB1R inverse agonist, INV ‐202, in patients with features of metabolic syndrome. A randomized, placebo‐controlled, double‐blind phase 1b study. Diabetes Obes Metab. Published 8 November 2023. doi:10.
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