RECRUITING

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Description

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.

Study Overview

Study Details

Study overview

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.

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Condition
Narcolepsy Type 1
Intervention / Treatment

-

Contacts and Locations

Chandler

Chandler, Arizona, Chandler, Arizona, United States, 85224

Scottsdale

Scottsdale, AZ, Scottsdale, Arizona, United States, 85255

Miami

Miami, Florida, Miami, Florida, United States, 33176

Winter Park

Winter Park, Florida, Winter Park, Florida, United States, 32789

Atlanta

Atlanta, Georgia, Atlanta, Georgia, United States, 30328

Henderson

Henderson, Nevada, Henderson, Nevada, United States, 89052

Denver

Denver, North Carolina, Denver, North Carolina, United States, 28037

Huntersville

Huntersville, North Carolina, Huntersville, North Carolina, United States, 28078

Cincinnati

Cincinnati, Ohio, Cincinnati, Ohio, United States, 45235

Columbia

Columbia, South Carolina, Columbia, South Carolina, United States, 29201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria
  • * Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia
  • * Is willing and able to adhere to additional protocol requirements
  • * A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).
  • * Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Centessa Pharmaceuticals (UK) Limited,

Study Record Dates

2025-12