A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Last updated: April 11, 2025
Sponsor: Centessa Pharmaceuticals (UK) Limited
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Idiopathic Hypersomnia

Narcolepsy

Treatment

ORX750

Placebo

Clinical Study ID

NCT06752668
ORX750-0201
2024-518929-15-00
  • Ages 18-65
  • All Genders

Study Summary

Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.

While all conditions result in feeling sleepy, there are some differences in other common symptoms:

  • NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.

  • NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.

  • IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up.

Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. ORX750 is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.

Eligibility Criteria

Inclusion

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 IdiopathicHypersomnia (IH) according to ICSD-3-TR criteria

  • Is willing and able to discontinue all medications used for the treatment ofnarcolepsy or idiopathic hypersomnia

  • Is willing and able to adhere to additional protocol requirements

Exclusion

Exclusion Criteria:

  • A medical disorder other than NT1, NT2, or IH that is associated with excessivedaytime sleepiness (EDS).

  • Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal,hematological, malignancy, endocrine, neurological or psychiatric disease

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: ORX750
Phase: 2
Study Start date:
December 23, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Toronto, Ontario

    Toronto, Ontario M5S 3A3
    Canada

    Active - Recruiting

  • Chandler, Arizona

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Scottsdale, AZ

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Miami, Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Winter Park, Florida

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Atlanta, Georgia

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Henderson, Nevada

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Denver, North Carolina

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Huntersville, North Carolina

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Cincinnati, Ohio

    Cincinnati, Ohio 45235
    United States

    Active - Recruiting

  • Centessa Investigational Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Columbia, South Carolina

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • San Antonio, Texas

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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