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

NCT07096674 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ORX750-202
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 24

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

  Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

  Up to day 70

• Abnormal Laboratory Tests

  Number of Participants With Abnormal Changes From Baseline in Laboratory Tests

  Up to day 70

• Abnormal Vital Signs

  Number of Participants With Abnormal Change From Baseline in Vital Signs

  Up to day 70

• Abnormal ECG

  Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)

  Up to day 70

• Suicidal Ideation or Behavior

  Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)

  Up to day 70

Secondary Outcomes (7)

• Cmax

  Up to day 63

• Tmax

  Up to day 63

• AUClast

  Up to day 63

• Cmax,ss

  Up to day 63

• AUCτ

  Up to day 63

Study Arms (3)

Narcolepsy Type 1

EXPERIMENTAL

Narcolepsy Type 1 (Open Label)

Drug: ORX750

Narcolepsy Type 2

EXPERIMENTAL

Narcolepsy Type 2 (Open Label)

Drug: ORX750

Idiopathic Hypersomnia

EXPERIMENTAL

Idiopathic Hypersomnia (Open Label)

Drug: ORX750

Interventions

ORX750 DRUG

Oral ORX750

Narcolepsy Type 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centessa Pharmaceuticals (UK) Limited: lead

Study Sites (24)

Auburn, alabama

Auburn, Alabama, 36832, United States

RECRUITING

Santa Ana, California

Santa Ana, California, 92705, United States

RECRUITING

Miami, Florida

Miami, Florida, 33176, United States

RECRUITING

Orlando, Florida

Orlando, Florida, 32807, United States

RECRUITING

Winter Park, FL

Winter Park, Florida, 32789, United States

RECRUITING

Stockbridge, GA

Atlanta, Georgia, 30281, United States

RECRUITING

Atlanta, Georgia

Atlanta, Georgia, 30328, United States

RECRUITING

Sterling Heights, Michigan

Sterling Heights, Michigan, 48314, United States

RECRUITING

Hendersen, Navada

Henderson, Nevada, 89052, United States

RECRUITING

Henderson, Nevada

Henderson, Nevada, 89052, United States

RECRUITING

Denver, North Carolina

Denver, North Carolina, 28037, United States

RECRUITING

Huntersville, North Carolina

Huntersville, North Carolina, 28070, United States

RECRUITING

Cincinnati, Ohio

Cincinnati, Ohio, 45245, United States

RECRUITING

Dublin

Dublin, Ohio, 43017, United States

RECRUITING

Abington, Pennsylvania

Abington, Pennsylvania, 19046, United States

RECRUITING

Willow Grove, Pennsylvania

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

North Charleston, South Carolina

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

RECRUITING

Austin, Texas

Austin, Texas, 30328, United States

RECRUITING

El Paso, Texas

El Paso, Texas, 79912, United States

RECRUITING

Toronto

Toronto, Ontario, M5S 3A3, Canada

RECRUITING

Bologna

Bologna, BO, 40139, Italy

RECRUITING

Verona

Verona, VR, 37134, Italy

RECRUITING

Móstoles, Madrid

Móstoles, Madrid, 28938, Spain

RECRUITING

Álava, Spain

Álava, 01004, Spain

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypersomnia; Narcolepsy; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Orexin Centessa Program Lead

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Long Term Extension Study

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 31, 2025
• Study Start: August 12, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (19); ES (2); CA (1); IT (2)