Recruiting

Phase 2

ORX750A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Sponsor:

Centessa Pharmaceuticals (UK) Limited

Code:

NCT07096674

Conditions

Narcolepsy Type 1

Narcolepsy Type 2

Idiopathic Hypersomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ORX750

Study Details

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).

Conditions

Narcolepsy Type 1

Narcolepsy Type 2

Idiopathic Hypersomnia

Study ID

NCT07096674

Start date

Aug 12, 2025

Status verified date

Apr, 2026

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Narcolepsy Type 1

Narcolepsy Type 1 (Open Label)

experimental: Narcolepsy Type 2

Narcolepsy Type 2 (Open Label)

experimental: Idiopathic Hypersomnia

Idiopathic Hypersomnia (Open Label)

Interventions

ORX750

Oral ORX750

ORX750

Oral ORX750

ORX750

Oral ORX750

Primary outcome measure

Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: Up to day 70 ]
Abnormal Laboratory Tests [ Time Frame: Up to day 70 ]
Abnormal Vital Signs [ Time Frame: Up to day 70 ]
Abnormal ECG [ Time Frame: Up to day 70 ]
Suicidal Ideation or Behavior [ Time Frame: Up to day 70 ]

Central Contacts and Locations

Central contacts

Orexin Centessa Program Lead

617-468-5770 ORX750-LTE@centessa.com

Locations

Auburn, alabama

Recruiting

Auburn, Alabama, United States, 36832

Santa Ana, California

Recruiting

Santa Ana, California, United States, 92705

Miami, Florida

Recruiting

Miami, Florida, United States, 33176

Orlando, Florida

Recruiting

Orlando, Florida, United States, 32807

Winter Park, FL

Recruiting

Winter Park, Florida, United States, 32789

Stockbridge, GA

Recruiting

Atlanta, Georgia, United States, 30281

Atlanta, Georgia

Recruiting

Atlanta, Georgia, United States, 30328

Sterling Heights, Michigan

Recruiting

Sterling Heights, Michigan, United States, 48314

Hendersen, Navada

Recruiting

Henderson, Nevada, United States, 89052

Henderson, Nevada

Recruiting

Henderson, Nevada, United States, 89052

Denver, North Carolina

Recruiting

Denver, North Carolina, United States, 28037

Huntersville, North Carolina

Recruiting

Huntersville, North Carolina, United States, 28070

Cincinnati, Ohio

Recruiting

Cincinnati, Ohio, United States, 45245

Dublin

Recruiting

Dublin, Ohio, United States, 43017

Abington, Pennsylvania

Recruiting

Abington, Pennsylvania, United States, 19046

Willow Grove, Pennsylvania

Recruiting

Willow Grove, Pennsylvania, United States, 19090

North Charleston, South Carolina

Recruiting

North Charleston, South Carolina, United States, 29406-9196

Austin, Texas

Recruiting

Austin, Texas, United States, 30328

El Paso, Texas

Recruiting

El Paso, Texas, United States, 79912

Toronto

Recruiting

Toronto, Ontario, Canada, M5S 3A3

More Information

Sponsor

Centessa Pharmaceuticals (UK) Limited

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

NT1
NT2
IH
Narcolepsy
Narcolepsy Type 1
Narcolepsy Type 2
Idiopathic Hypersomnia
Excessive Daytime Sleepiness
Orexin Receptor 2 agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centessa Pharmaceuticals (UK) Limited on 2026-04-16.