Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06752668

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Led by Centessa Pharmaceuticals (UK) Limited · Updated on 2026-04-27

248

Participants Needed

37

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. Cleminorexton (also known as 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.

CONDITIONS

Official Title

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Body Mass Index (BMI) between 17 and 37 kg/m2
  • Diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia according to ICSD-3-TR criteria
  • Willing and able to stop all medications for narcolepsy or idiopathic hypersomnia
  • Willing and able to follow all study requirements
Not Eligible

You will not qualify if you...

  • Having any medical disorder besides NT1, NT2, or IH that causes excessive daytime sleepiness
  • Having significant cardiovascular, lung, digestive, liver, kidney, blood, cancer, hormone, neurological, or psychiatric diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 37 locations

1

Auburn, Alabama

Auburn, Alabama, United States, 36832

Actively Recruiting

2

Chandler, Arizona

Chandler, Arizona, United States, 85224

Actively Recruiting

3

Scottsdale, Arizona

Scottsdale, Arizona, United States, 85253

Actively Recruiting

4

Long Beach, California

Long Beach, California, United States, 90805

Actively Recruiting

5

Santa Ana, California

Santa Ana, California, United States, 92705

Actively Recruiting

6

Brandon, Florida

Brandon, Florida, United States, 33511

Actively Recruiting

7

Miami, Florida

Miami, Florida, United States, 33155

Actively Recruiting

8

Miami, Florida

Miami, Florida, United States, 33176

Actively Recruiting

9

Orlando, FL

Orlando, Florida, United States, 32807

Actively Recruiting

10

Winter Park, Florida

Winter Park, Florida, United States, 32789

Actively Recruiting

11

Atlanta, Georgia

Atlanta, Georgia, United States, 30281

Actively Recruiting

12

Atlanta, Georgia

Atlanta, Georgia, United States, 30328

Actively Recruiting

13

Riverdale, Georgia

Riverdale, Georgia, United States, 30274

Actively Recruiting

14

New Orleans, Louisiana

New Orleans, Louisiana, United States, 70127

Actively Recruiting

15

Newton, Massachusetts

Newton, Massachusetts, United States, 02459

Actively Recruiting

16

Southfield, Michigan

Southfield, Michigan, United States, 48075

Actively Recruiting

17

Sterling Heights, Michigan

Sterling Heights, Michigan, United States, 48314

Actively Recruiting

18

Henderson, Nevada

Henderson, Nevada, United States, 89052

Actively Recruiting

19

Denver, North Carolina

Denver, North Carolina, United States, 28037

Actively Recruiting

20

Huntersville, North Carolina

Huntersville, North Carolina, United States, 28078

Actively Recruiting

21

Cincinnati, Ohio

Cincinnati, Ohio, United States, 45245

Actively Recruiting

22

Cleveland, OH

Cleveland, Ohio, United States, 44106

Actively Recruiting

23

Dublin, Ohio

Dublin, Ohio, United States, 43017

Actively Recruiting

24

Willow Grove, Pennsylvania

Willow Grove, Pennsylvania, United States, 19090

Actively Recruiting

25

Columbia, South Carolina

Columbia, South Carolina, United States, 29201

Actively Recruiting

26

North Charleston, South Carolina

North Charleston, South Carolina, United States, 29406

Actively Recruiting

27

Austin, Texas

Austin, Texas, United States, 78731

Actively Recruiting

28

El Paso, TX

El Paso, Texas, United States, 79912

Actively Recruiting

29

San Antonio, Texas

San Antonio, Texas, United States, 78229

Actively Recruiting

30

Toronto, Ontario

Toronto, Ontario, Canada, M5S 3A3

Actively Recruiting

31

Leon, France

Léon, Bordeaux, France, 33000

Actively Recruiting

32

Bologna, Italy

Bologna, Italy, 40139

Actively Recruiting

33

Pozzilli, Italy

Pozzilli, Italy, 86077

Actively Recruiting

34

Verona, Italy

Verona, Italy, 37134

Actively Recruiting

35

Madrid, Spain

Madrid, Spain, 28036

Actively Recruiting

36

Madrid, Spain

Madrid, Spain, 28043

Actively Recruiting

37

Vitoria-Gasteiz, Spain

Vitoria-Gasteiz, Spain, 01009

Actively Recruiting

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Research Team

C

Centessa Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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