NCT05448443

Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome

Crossover, Double-blind, Phase 2 Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, placebo-controlled, cross-over, phase II, single center efficacy study of AD981 in patients with obesity hypoventilation syndrome documented by polysomnography (PSG) and transcutaneous, overnight measurement of CO2 (PtcCO2).

Conditions

• Obesity Hypoventilation Syndrome (OHS)

Interventions

Type	Name	Description
DRUG	AD981	Oral administration of AD981 in the morning and before sleep for 14 days
OTHER	Placebo	Oral administration of placebo in the morning and before sleep for 14 days

Timeline

• Start date: 2022-06-21
• Primary completion: 2024-05-08
• Completion: 2024-05-08
• First posted: 2022-07-07
• Last updated: 2025-02-27

Locations

1 site across 1 country: Italy