Completed

ATOHSAD981 Treatment for Obesity Hypoventilation Syndrome

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Study Aim

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.

What is being tested

AD981

+ Placebo

DrugOther
Who is being recruted

Apnea+14

+ Hypoventilation

+ Nervous System Diseases

From 18 to 75 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2022
See protocol details

Summary

Principal SponsorIstituto Auxologico Italiano
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleCrossover, Double-blind, Phase 2 Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome
Principal SponsorIstituto Auxologico Italiano
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

ApneaHypoventilationNervous System DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesityObesity Hypoventilation SyndromeRespiration DisordersRespiratory InsufficiencyRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomniasOvernutritionOverweight

Criteria

4 inclusion criteria required to participate
Be able to understand the nature of the study and sign the informed consent

BMI > 35 kg/m2 and presence of nocturnal hypoventilation

Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment

If in treatment, CPAP or BPAP or mandibular advancement device or positional therapy intolerance or poor compliance

18 exclusion criteria prevent from participating
Narcolepsy, craniofacial malformation, renal failure, hepatic disease, schizophrenia, schizoaffective disorder or bipolar disorder, cognitive dysfunction, severe neurological disorder, pheochromocytoma, adrenocortical insufficiency, hyperchloremic acidosis.

Respiratory (COPD, ILD, oxygen therapy) or cardiac (Heart Failure, Atrial fibrillation, established severe peripheral arterial disease) disease or hypertension requiring more than 3 medications for control

Cardiomyopathies, heart malformation or structural heart alterations, severe rhythm disorders, established coronary heart disease or other cardiac conditions, which could determine sudden death

Attempted suicide or suicidal ideation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
AD981

Group II

Placebo
Placebo

Study 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

Suspended

Istituto Auxologico Italiano,Ospedale San Luca

Milan, ItalyOpen Istituto Auxologico Italiano,Ospedale San Luca in Google Maps
CompletedOne Study Center