Actively Recruiting
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
Led by Centessa Pharmaceuticals (UK) Limited · Updated on 2026-04-27
248
Participants Needed
37
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH). These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups: those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.
CONDITIONS
Brief 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 by 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 other than NT1, NT2, or IH that causes excessive daytime sleepiness
- Having significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, cancer, endocrine, neurological, or psychiatric disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days
Participants receive ORX750 or placebo capsules to assess safety, tolerability, and effects on narcolepsy and idiopathic hypersomnia.
Visits on Day 1, 15, and 28
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
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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