A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Last updated: October 28, 2025
Sponsor: Centessa Pharmaceuticals (UK) Limited
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Narcolepsy

Idiopathic Hypersomnia

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: 96
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

    Site Not Available

  • Toronto, Ontario

    Toronto 6167865, Ontario 6093943 M5S 3A3
    Canada

    Active - Recruiting

  • Auburn, Alabama

    Auburn, Alabama 36832
    United States

    Site Not Available

  • Auburn, Alabama

    Auburn 4830796, Alabama 4829764 36832
    United States

    Active - Recruiting

  • Chandler, Arizona

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Scottsdale, AZ

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Scottsdale, Arizona

    Scottsdale, Arizona 85253
    United States

    Site Not Available

  • Chandler, Arizona

    Chandler 5289282, Arizona 5551752 85224
    United States

    Active - Recruiting

  • Scottsdale, Arizona

    Scottsdale 5313457, Arizona 5551752 85253
    United States

    Active - Recruiting

  • Long Beach, California

    Long Beach, California 90805
    United States

    Site Not Available

  • Santa Ana, California

    Santa Ana, California 92705
    United States

    Site Not Available

  • Long Beach, California

    Long Beach 5367929, California 5332921 90805
    United States

    Active - Recruiting

  • Santa Ana, California

    Santa Ana 5392900, California 5332921 92705
    United States

    Active - Recruiting

  • Brandon, Florida

    Brandon, Florida 33511
    United States

    Site Not Available

  • Miami, Florida

    Miami, Florida 33155
    United States

    Site Not Available

  • Winter Park, Florida

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Brandon, Florida

    Brandon 4148757, Florida 4155751 33511
    United States

    Active - Recruiting

  • Miami, Florida

    Miami 4164138, Florida 4155751 33176
    United States

    Active - Recruiting

  • Orlando, FL

    Orlando 4167147, Florida 4155751 32807
    United States

    Active - Recruiting

  • Winter Park, Florida

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • Atlanta, Georgia

    Atlanta, Georgia 30281
    United States

    Site Not Available

  • Atlanta, Georgia

    Atlanta 4180439, Georgia 4197000 30281
    United States

    Active - Recruiting

  • Riverdale, Georgia

    Riverdale 4219001, Georgia 4197000 30274
    United States

    Active - Recruiting

  • New Orleans, Louisiana

    New Orleans, Louisiana 70127
    United States

    Site Not Available

  • New Orleans, Louisiana

    New Orleans 4335045, Louisiana 4331987 70127
    United States

    Active - Recruiting

  • Newton, Massachusetts

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Newton, Massachusetts

    Newton 4945283, Massachusetts 6254926 02459
    United States

    Active - Recruiting

  • Sterling Heights, Michigan

    Sterling Heights, Michigan 48314
    United States

    Site Not Available

  • Southfield, Michigan

    Southfield 5010636, Michigan 5001836 48075
    United States

    Active - Recruiting

  • Sterling Heights, Michigan

    Sterling Heights 5011148, Michigan 5001836 48314
    United States

    Active - Recruiting

  • Henderson, Nevada

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Henderson, Nevada

    Henderson 5505411, Nevada 5509151 89052
    United States

    Active - Recruiting

  • Denver, North Carolina

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Huntersville, North Carolina

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Denver, North Carolina

    Denver 4463523, North Carolina 4482348 28037
    United States

    Active - Recruiting

  • Huntersville, North Carolina

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • Cincinnati, Ohio

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Dublin, Ohio

    Dublin, Ohio 43017
    United States

    Site Not Available

  • Cincinnati, Ohio

    Cincinnati 4508722, Ohio 5165418 45245
    United States

    Active - Recruiting

  • Cleveland, OH

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Dublin, Ohio

    Dublin 5152333, Ohio 5165418 43017
    United States

    Active - Recruiting

  • Willow Grove, Pennsylvania

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Willow Grove, Pennsylvania

    Willow Grove 5219619, Pennsylvania 6254927 19090
    United States

    Active - Recruiting

  • Centessa Investigational Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Columbia, South Carolina

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • North Charleston, South Carolina

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Columbia, South Carolina

    Columbia 4575352, South Carolina 4597040 29201
    United States

    Active - Recruiting

  • North Charleston, South Carolina

    North Charleston 4589387, South Carolina 4597040 29406
    United States

    Active - Recruiting

  • Austin, Texas

    Austin, Texas 78731
    United States

    Site Not Available

  • San Antonio, Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Austin, Texas

    Austin 4671654, Texas 4736286 78731
    United States

    Active - Recruiting

  • San Antonio, Texas

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.