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Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome

NCT05448443 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Apnimed Inc.

    collaborator UNKNOWN

  • VIS Ethic Research Srl

    collaborator UNKNOWN

  • University of Florence

    collaborator OTHER

  • STM Pharma PRO srl

    collaborator UNKNOWN

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Elisa Perger, MD · Istituto Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2024-05-08
Completion
2024-05-08

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05448443 on ClinicalTrials.gov