Cleminorexton compared with placebo for daytime sleepiness in narcolepsy type 1 and type 2
Tests cleminorexton against placebo in adults with narcolepsy type 1 or type 2.
Key facts
- Who runs it
- Centessa Pharmaceuticals (UK) Limited
- Where
- Atlanta, Austin, Birmingham, Brandon, Cincinnati, Colorado Springs, Columbia, Dallas, Denver, Dublin, Flowood, Frisco, Houston, Huntersville, Lansing, Miami, Miami Lakes, Orlando, Rincon, San Antonio, St. Petersburg, Stockbridge, and Sugar Land, United StatesSee the 23 sites
- Trial code
- Registry title
- A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 222 people, planned
- Started
- 29 May 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- cleminorexton
- Placebo
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with narcolepsy type 1 or type 2. It compares cleminorexton with placebo, a dummy drug.
- Age
- 18 to 70 years
- Sex
- All sexes
- Disease stage
- Narcolepsy Type 1 (NT1) or Type 2 (NT2), diagnosed by ICSD-3-TR criteria. Body Mass Index (BMI) must be ≥ 17.0 and ≤ 45 kg/m^2.
- Earlier treatment
- People must be willing and able to stop all medicines they take for narcolepsy.
Main reasons for not taking part
- Another medical disorder, besides NT1 or NT2, that causes strong daytime sleepiness
- Significant heart, lung, gut, liver, kidney or blood disease
- Cancer
- Significant hormone, nerve or mental health disease
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- Atlanta, GeorgiaAtlanta, United StatesContact: Centessa PharmaceuticalsTaking people
- Austin, TexasAustin, United StatesContact: Centessa PharmaceuticalsTaking people
- Birmingham, AlabamaBirmingham, United StatesContact: Centessa PharmaceuticalsTaking people
- Brandon, FloridaBrandon, United StatesContact: Centessa PharmaceuticalsTaking people
- Cincinnati, OhioCincinnati, United StatesContact: Centessa PharmaceuticalsTaking people
- Colorado Springs, ColoradoColorado Springs, United StatesContact: Centessa PharmaceuticalsTaking people
- Columbia, South CarolinaColumbia, United StatesContact: Centessa PharmaceuticalsTaking people
- Dallas, TexasDallas, United StatesContact: Centessa PharmaceuticalsTaking people
- Denver, North CarolinaDenver, United StatesContact: Centessa PharmaceuticalsTaking people
- Dublin, OhioDublin, United StatesContact: Centessa PharmaceuticalsTaking people
- Flowood, MississippiFlowood, United StatesContact: Centessa PharmaceuticalsTaking people
- Frisco, TexasFrisco, United StatesContact: Centessa PharmaceuticalsTaking people
- Houston, TexasHouston, United StatesContact: Centessa PharmaceuticalsTaking people
- Huntersville, North CarolinaHuntersville, United StatesContact: Centessa PharmaceuticalsTaking people
- Lansing, MichiganLansing, United StatesContact: Centessa PharmaceuticalsTaking people
- Miami, FloridaMiami, United StatesContact: Centessa PharmaceuticalsTaking people
- Miami Lakes, FloridaMiami Lakes, United StatesContact: Centessa PharmaceuticalsTaking people
- Orlando, FloridaOrlando, United StatesContact: Centessa PharmaceuticalsTaking people
- Rincon, GeorgiaRincon, United StatesContact: Centessa PharmaceuticalsTaking people
- San Antonio, TexasSan Antonio, United StatesContact: Centessa PharmaceuticalsTaking people
- St. Petersburg, FloridaSt. Petersburg, United StatesContact: Centessa PharmaceuticalsTaking people
- Stockbridge, GeorgiaStockbridge, United StatesContact: Centessa PharmaceuticalsTaking people
- Sugar Land, TexasSugar Land, United StatesContact: Centessa PharmaceuticalsTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 6 groups in the trial
- Group A - Narcolepsy Type 1 (Dose 1)Treatment being tested
Treatment: cleminorexton
- Group A - Narcolepsy Type 1 (Dose 2)Treatment being tested
Treatment: cleminorexton
- Group A - Narcolepsy Type 1 (placebo)Placebo, for comparison
Treatment: Placebo
- Group B - Narcolepsy Type 2 (Dose 1)Treatment being tested
Treatment: cleminorexton
- Group B - Narcolepsy Type 2 (Dose 2)Treatment being tested
Treatment: cleminorexton
- Group B - Narcolepsy Type 2 (placebo)Placebo, for comparison
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence
- Plain-language title
- Cleminorexton compared with placebo for daytime sleepiness in narcolepsy type 1 and type 2Generated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07598708, who can take part
- Record updated
- 3 November 2026