NCT07096674 A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
| NCT ID | NCT07096674 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centessa Pharmaceuticals (UK) Limited |
| Condition | Narcolepsy Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-08-12 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).
Eligibility Criteria
Inclusion Criteria: * Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1) * Is willing and able to adhere to additional protocol requirements Exclusion Criteria: * Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study * Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07096674 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Narcolepsy Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07096674 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07096674 currently recruiting?
Yes, NCT07096674 is actively recruiting participants. Contact the research team at ORX750-LTE@centessa.com for enrollment information.
Where is the NCT07096674 trial being conducted?
This trial is being conducted at Auburn, United States, Santa Ana, United States, Miami, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT07096674 clinical trial?
NCT07096674 is sponsored by Centessa Pharmaceuticals (UK) Limited. The trial plans to enroll 90 participants.