A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Centessa Pharmaceuticals (UK) Limited · NCT07598708
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–70 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 222
- US sites recruiting
- 23
- Study start
- May 29, 2026
- Record last updated
- October 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) 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.
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 is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.
Being studied: cleminorexton; Placebo
Conditions: Narcolepsy Type 1; Narcolepsy Type 2
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key Inclusion Criteria
- 18-70 years of age
- Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg/m\^2 (inclusive)
- Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria
- Is willing and able to discontinue all medications used for the treatment of narcolepsy
- Is willing and able to adhere to additional protocol requirements
Key Exclusion Criteria
- Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)
- Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
Recruiting US locations
Birmingham, Alabama
Birmingham, AL 35213
Colorado Springs, Colorado
Colorado Springs, CO 80918
Brandon, Florida
Brandon, FL 33511
Miami, Florida
Miami, FL 33155
Miami, Florida
Miami, FL 33166
Miami, Florida
Miami, FL 33176
Miami, Florida
Miami, FL 33186
Miami Lakes, Florida
Miami Lakes, FL 33014
Orlando, Florida
Orlando, FL 32807
St. Petersburg, Florida
St. Petersburg, FL 33707
Atlanta, Georgia
Atlanta, GA 30328
Rincon, Georgia
Rincon, GA 31326
Flowood Mississippi
Flowood, MS 39232
Denver, North Carolina
Denver, NC 28037
Huntersville, North Carolina
Huntersville, NC 28078
Cincinnati, Ohio
Cincinnati, OH 45245
Dublin, Ohio
Dublin, OH 43017
Columbia, South Carolina
Columbia, SC 29201
Austin, Texas
Austin, TX 78731
Dallas, Texas
Dallas, TX 75251
Houston, Texas
Houston, TX 77070
San Antonio, Texas
San Antonio, TX 78229
Sugar Land, Texas
Sugar Land, TX 77478
Study contacts (from the official record)
- Centessa Pharmaceuticals · 617-468-5770 · ORX750trials@centessa.com
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