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A Study of ORX750 for Narcolepsy and Idiopathic Hypersomnia

This study is testing a new drug called ORX750 for people with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH). These conditions cause extreme daytime sleepiness. The study aims to see how safe ORX750 is by tracking any side effects (adverse events), changes in lab tests, and changes in vital signs like blood pressure. You might be able to join if you are 18-65 years old, meet the diagnostic criteria for NT1, NT2, or IH, and are willing to stop your current sleep medications. The study plans to enroll 248 participants.

Study design
This is an interventional study, meaning participants will receive either ORX750 or a matching placebo. The phase of the study is not specified.
What's involved
You would need to be willing and able to discontinue all medications used for narcolepsy or idiopathic hypersomnia and adhere to additional study requirements.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured up to Day 35 after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06752668

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Centessa Pharmaceuticals (UK) Limited
~248 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:ORX750Placebo

At a glance

Recruiting sites
37 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Measured over Up to Day 35
+4 more outcomes measured

Conditions

Narcolepsy Type 1
Narcolepsy Type 2
Idiopathic Hypersomnia

Explore related trials

Idiopathic HypersomniaNarcolepsy type 1Narcolepsy without Cataplexy

Where it's being run

37 sites across 18 states
Florida5
Georgia3
Ohio3
Texas3
Italy3
Spain3
Arizona2
California2

Who to contact

Centessa Pharmaceuticals
[email protected]
+1 617-468-5770
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18-65 years of age
BMI ≥17 and ≤37 kg/m2
Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria
Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia
Is willing and able to adhere to additional protocol requirements

Exclusion

A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).
Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

What this trial measures

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEsUp to Day 35
  • Number of Participants With Abnormal Changes From Baseline in Laboratory TestsUp to Day 35
  • Number of Participants With Abnormal Change From Baseline in Vital SignsUp to Day 35
  • Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)Up to Day 35
  • Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)Up to Day 35