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Recruiting Phase 2 Interventional

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

ClinicalTrials.gov ID: NCT06752668

Public ClinicalTrials.gov record NCT06752668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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 (CRYSTAL-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) 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. * 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. Cleminorexton (also known as 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.

Study identification

NCT ID
NCT06752668
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
248 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 22, 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026
Last update posted
Apr 26, 2026

2024 – 2026

United States locations

U.S. sites
29
U.S. states
14
U.S. cities
27
Facility City State ZIP Site status
Auburn, Alabama Auburn Alabama 36832 Recruiting
Chandler, Arizona Chandler Arizona 85224 Recruiting
Scottsdale, Arizona Scottsdale Arizona 85253 Recruiting
Long Beach, California Long Beach California 90805 Recruiting
Santa Ana, California Santa Ana California 92705 Recruiting
Brandon, Florida Brandon Florida 33511 Recruiting
Miami, Florida Miami Florida 33155 Recruiting
Miami, Florida Miami Florida 33176 Recruiting
Orlando, FL Orlando Florida 32807 Recruiting
Winter Park, Florida Winter Park Florida 32789 Recruiting
Atlanta, Georgia Atlanta Georgia 30281 Recruiting
Atlanta, Georgia Atlanta Georgia 30328 Recruiting
Riverdale, Georgia Riverdale Georgia 30274 Recruiting
New Orleans, Louisiana New Orleans Louisiana 70127 Recruiting
Newton, Massachusetts Newton Massachusetts 02459 Recruiting
Southfield, Michigan Southfield Michigan 48075 Recruiting
Sterling Heights, Michigan Sterling Heights Michigan 48314 Recruiting
Henderson, Nevada Henderson Nevada 89052 Recruiting
Denver, North Carolina Denver North Carolina 28037 Recruiting
Huntersville, North Carolina Huntersville North Carolina 28078 Recruiting
Cincinnati, Ohio Cincinnati Ohio 45245 Recruiting
Cleveland, OH Cleveland Ohio 44106 Recruiting
Dublin, Ohio Dublin Ohio 43017 Recruiting
Willow Grove, Pennsylvania Willow Grove Pennsylvania 19090 Recruiting
Columbia, South Carolina Columbia South Carolina 29201 Recruiting
North Charleston, South Carolina North Charleston South Carolina 29406 Recruiting
Austin, Texas Austin Texas 78731 Recruiting
El Paso, TX El Paso Texas 79912 Recruiting
San Antonio, Texas San Antonio Texas 78229 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06752668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 26, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06752668 live on ClinicalTrials.gov.

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