Actively Recruiting
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
Eligibility Criteria
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
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
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
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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