Obesity Hypoventilation Syndrome (OHS)Phase 2ATOHSNCT05448443
Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome
A Phase 2 study testing AD981 in people with Obesity Hypoventilation Syndrome (OHS), run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- AD981
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2022to 8 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Drugs of abuse or substance use disorder
- A significant illness or infection requiring medical treatment in the past 30 days.
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- Untreated narrow angle glaucoma.
- Women who are pregnant or nursing.
- Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment, allergies to sulfonamides.
- Diabetes with unstable glucose control in the past 15 days.
- > 500 mg/day of Aspirin
- Low sodium or potassium.
- Any condition that in the investigator's opinion would present an unreasonable risk to the participant.
- History of using oral or nasal devices (such as mandibular advancement devices) for the treatment of OSA may enroll as long as the devices are not used during participation in the study for at least 2 weeks prior to study begin.
- History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
- Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
- Patient currently receiving: MAOIs, Serotonin and Norepinephrine Reuptake Inhibitors, Norepinephrine Reuptake Inhibitors, Lithium, Tricyclic antidepressants, strong CYP2D6 inhibitors, other strong inhibitors cytochrome P450, thiazides diuretics, benzodiazepines, opioids, drugs with clinically significant cardiac QT-interval prolonging effects, drugs known to lower seizure threshold, amphetamines, antiepileptics, modafinil or armodafinil, beta2 agonists, antipsychotics, pseudoephedrine, phenylephrine, oxymetazoline, drugs for Parkinson's, Alzheimer's, Huntington's, Amyotrophic Lateral Sclerosis, or drugs for other neurodegenerative diseases, more than 500 mg/day of Aspirin or salicylates, sodium Phosphate.
- Known hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crossover, Double-blind, Phase 2 Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome
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)
- Being tested
- AD981, Placebo
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD981Drug
Oral administration of AD981 in the morning and before sleep for 14 days
PlaceboOther
Oral administration of placebo in the morning and before sleep for 14 days
| Study group | Role | What they receive |
|---|---|---|
| AD981 | Experimental | AD981 Receives: Drug: AD981 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal transcutaneous CO2 pressure (PtcCO2)
Measured: From baseline to the last day of treatment (14 days after the start of each treatment period)
Secondary outcomes (2)
Proportion of participants without nocturnal hypoventilation
Measured: From baseline to the last day of treatment (14 days after the start of each treatment period)
Apnea-Hypopnea Index (AHI)
Measured: From baseline to the last day of treatment (14 days after the start of each treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start21 Jun 2022
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients who meet the eligibility criteria will be randomized equally to receive AD981 or matching placebo. After 14 days of treatment and a washout period, the patients crossover to the other treatment arm for 14 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Apnimed Inc., VIS Ethic Research Srl, University of Florence, STM Pharma PRO srl
- Responsible party
- Sponsor
- Investigators
- Elisa Perger, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448443
- Sponsor's protocol ID
- 09J201
- Acronym
- ATOHS
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perger E, Parati G, Faini A, Gell L, Faverio P, Luppi F, Bertoli S, Brunani A, Bigagli E, Lombardi C, Taranto-Montemurro L. Acetazolamide Plus Atomoxetine for Obesity Hypoventilation Syndrome Treatment. Chest. 2026 Feb;169(2):527-537. doi: 10.1016/j.chest.2025.09.019. Epub 2025 Sep 25.
PubMed 41015199
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover, Double-blind, Phase 2 Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT05448443
- Acronym / sponsor ID
- ATOHS / 09J201
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Apnimed Inc., VIS Ethic Research Srl, University of Florence, STM Pharma PRO srl
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who meet the eligibility criteria will be randomized equally to receive AD981 or matching placebo. After 14 days of treatment and a washout period, the patients crossover to the other treatment arm for 14 days.
| Arm | Type | Receives |
|---|---|---|
| AD981 | Experimental | Drug: AD981AD981 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- Drugs of abuse or substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD981Oral administration of AD981 in the morning and before sleep for 14 days | Drug | AD981 |
| PlaceboOral administration of placebo in the morning and before sleep for 14 days | Other | Placebo |
Primary outcome
Nocturnal transcutaneous CO2 pressure (PtcCO2)
Time frame: From baseline to the last day of treatment (14 days after the start of each treatment period)
2 secondary outcomes
Proportion of participants without nocturnal hypoventilation
Time frame: From baseline to the last day of treatment (14 days after the start of each treatment period)
Apnea-Hypopnea Index (AHI)
Time frame: From baseline to the last day of treatment (14 days after the start of each treatment period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 41015199Perger E, Parati G, Faini A, Gell L, Faverio P, Luppi F, Bertoli S, Brunani A, Bigagli E, Lombardi C, Taranto-Montemurro L. Acetazolamide Plus Atomoxetine for Obesity Hypoventilation Syndrome Treatment. Chest. 2026 Feb;169(2):527-537. doi: 10.1016/j.chest.2025.09.019. Epub 2025 Sep 25.
- Individual participant dataSharing planned: No
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The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Perger, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD981 in people with Obesity Hypoventilation Syndrome (OHS), run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal transcutaneous CO2 pressure (PtcCO2) (time frame: From baseline to the last day of treatment (14 days after the start of each treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.