A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
NCT ID: NCT06752668
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2024-12-23
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Narcolepsy Type 1: ORX750 and Placebo
ORX750
ORX750 capsule.
Placebo
ORX750 matching placebo capsule.
Narcolepsy Type 2: ORX750 and Placebo
ORX750
ORX750 capsule.
Placebo
ORX750 matching placebo capsule.
Idiopathic Hypersomnia: ORX750 and Placebo
ORX750
ORX750 capsule.
Placebo
ORX750 matching placebo capsule.
Interventions
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ORX750
ORX750 capsule.
Placebo
ORX750 matching placebo capsule.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
18 Years
65 Years
ALL
No
Sponsors
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Centessa Pharmaceuticals (UK) Limited
INDUSTRY
Responsible Party
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Locations
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Auburn, Alabama
Auburn, Alabama, United States
Chandler, Arizona
Chandler, Arizona, United States
Scottsdale, Arizona
Scottsdale, Arizona, United States
Long Beach, California
Long Beach, California, United States
Santa Ana, California
Santa Ana, California, United States
Brandon, Florida
Brandon, Florida, United States
Miami, Florida
Miami, Florida, United States
Miami, Florida
Miami, Florida, United States
Orlando, FL
Orlando, Florida, United States
Winter Park, Florida
Winter Park, Florida, United States
Atlanta, Georgia
Atlanta, Georgia, United States
Atlanta, Georgia
Atlanta, Georgia, United States
Riverdale, Georgia
Riverdale, Georgia, United States
New Orleans, Louisiana
New Orleans, Louisiana, United States
Newton, Massachusetts
Newton, Massachusetts, United States
Southfield, Michigan
Southfield, Michigan, United States
Sterling Heights, Michigan
Sterling Heights, Michigan, United States
Henderson, Nevada
Henderson, Nevada, United States
Denver, North Carolina
Denver, North Carolina, United States
Huntersville, North Carolina
Huntersville, North Carolina, United States
Cincinnati, Ohio
Cincinnati, Ohio, United States
Cleveland, OH
Cleveland, Ohio, United States
Dublin, Ohio
Dublin, Ohio, United States
Willow Grove, Pennsylvania
Willow Grove, Pennsylvania, United States
Columbia, South Carolina
Columbia, South Carolina, United States
North Charleston, South Carolina
North Charleston, South Carolina, United States
Austin, Texas
Austin, Texas, United States
San Antonio, Texas
San Antonio, Texas, United States
Toronto, Ontario
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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2024-518929-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
ORX750-0201
Identifier Type: -
Identifier Source: org_study_id
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