ATOHSAD981 Treatment for Obesity Hypoventilation Syndrome
This phase 2 study aims to evaluate the effectiveness of AD981 treatment in reducing nocturnal transcutaneous CO2 pressure (PtcCO2) in individuals with Obesity Hypoventilation Syndrome.
AD981
+ Placebo
Apnea+14
+ Hypoventilation
+ Nervous System Diseases
Treatment Study
Summary
Study start date: June 21, 2022
Actual date on which the first participant was enrolled.This study is a phase 2 trial that explores the effectiveness of a drug called AD981 in treating obesity hypoventilation syndrome, a condition where individuals with obesity have difficulty breathing properly, leading to higher levels of carbon dioxide in the blood. The study focuses on patients who have this condition confirmed through a sleep study (polysomnography) and overnight measurement of carbon dioxide levels through the skin (transcutaneous overnight measurement of CO2). The goal is to find a potential new treatment that could help manage this condition better. In this study, participants receive either AD981 or a placebo, a substance that looks like the drug but has no active ingredients. Neither the participants nor the researchers know who gets which, ensuring the results are unbiased. This is a 'cross-over' study, meaning participants who initially receive the placebo will later receive AD981, and vice versa. The main outcome measured is the change in carbon dioxide levels in the blood overnight, which helps determine if AD981 is effective in managing obesity hypoventilation syndrome.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Istituto Auxologico Italiano,Ospedale San Luca
Milan, ItalyOpen Istituto Auxologico Italiano,Ospedale San Luca in Google Maps