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Testing ORX750 for Narcolepsy and Idiopathic Hypersomnia

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)

Phase 2 Interventional Centessa Pharmaceuticals plc · NCT06752668

This study is testing a new medication called ORX750 to see if it can help people with narcolepsy or idiopathic hypersomnia feel more awake and improve their daily lives.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment248 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorCentessa Pharmaceuticals plc Industry-sponsored
Locations37 sites (Auburn, Alabama and 36 other locations)
Trial IDNCT06752668 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of ORX750 in treating participants diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia, conditions characterized by excessive daytime sleepiness. Participants aged 18-65 will be recruited and must be willing to discontinue any current medications for their conditions. The study will compare the effects of ORX750 against a placebo to determine its potential benefits in improving alertness and daily functioning. The trial aims to gather data on how well ORX750 can alleviate symptoms associated with these sleep disorders.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with a confirmed diagnosis of Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia.

Not a fit: Patients with excessive daytime sleepiness due to other medical disorders or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from excessive daytime sleepiness due to narcolepsy or idiopathic hypersomnia.

How similar studies have performed: While there is ongoing research in this area, the specific use of ORX750 for these conditions is novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Auburn, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.