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AD981

Phase 2

Obesity Hypoventilation Syndrome (OHS) | Small molecule | Other |Apnimed, Inc.|Trials Updated: Feb 27, 2025

AD981 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

AD981 clinical trials

AD981 · 1 trial · 1 indication

Phase 2 1
NCT05448443Study of AD981 Versus Placebo in Obesity Hypoventilation SyndromeObesity Hypoventilation Syndrome (OHS)
COMPLETED15 Analytics
PHASE2COMPLETED
Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome
Obesity Hypoventilation Syndrome (OHS)
NCT0544844315
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Study Endpoints

Primary Endpoints

Nocturnal transcutaneous CO2 pressure (PtcCO2)
From baseline to the last day of treatment (14 days after the start of each treatment period)

Secondary Endpoints

Proportion of participants without nocturnal hypoventilation
From baseline to the last day of treatment (14 days after the start of each treatment period)
Apnea-Hypopnea Index (AHI)
From baseline to the last day of treatment (14 days after the start of each treatment period)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AD981EXPERIMENTALAD981
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AD981DRUGOral administration of AD981 in the morning and before sleep for 14 days
PlaceboOTHEROral administration of placebo in the morning and before sleep for 14 days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 de...

Countries:Italy
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