NCT07598708 A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
| NCT ID | NCT07598708 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Centessa Pharmaceuticals (UK) Limited |
| Condition | Narcolepsy Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 222 participants in total. It began in 2026-05-29 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07598708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Narcolepsy Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07598708 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07598708 currently recruiting?
Yes, NCT07598708 is actively recruiting participants. Contact the research team at ORX750trials@centessa.com for enrollment information.
Where is the NCT07598708 trial being conducted?
This trial is being conducted at Birmingham, United States, Colorado Springs, United States, Brandon, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT07598708 clinical trial?
NCT07598708 is sponsored by Centessa Pharmaceuticals (UK) Limited. The trial plans to enroll 222 participants.