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NCT06752668 · ClinicalTrials.gov registry record · Phase 2

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

A Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1, sponsored by Centessa Pharmaceuticals (UK) Limited.

Recruiting
Registry status
Phase 2
Development phase
96
Enrollment target
20
Study locations

NCT06752668 is a Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1 that is actively recruiting participants, run by Centessa Pharmaceuticals (UK) Limited. The registered enrollment target is 96 participants, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT06752668, a Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1, is actively recruiting participants, sponsored by Centessa Pharmaceuticals (UK) Limited.

RECRUITING
Registry status
Phase 2
Development phase
96 participants
Enrollment target
20
Study locations

Study Summary

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. 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.

Interventions

  • DRUG Placebo
  • DRUG ORX750

Study Locations (20)

Florida

  • Brandon, Florida - Brandon
  • Miami, Florida - Miami
  • Miami, Florida - Miami
  • Orlando, FL - Orlando
  • Winter Park, Florida - Winter Park

Georgia

  • Atlanta, Georgia - Atlanta
  • Atlanta, Georgia - Atlanta
  • Riverdale, Georgia - Riverdale

Arizona

  • Chandler, Arizona - Chandler
  • Scottsdale, Arizona - Scottsdale

California

  • Long Beach, California - Long Beach
  • Santa Ana, California - Santa Ana

Michigan

  • Southfield, Michigan - Southfield
  • Sterling Heights, Michigan - Sterling Heights

North Carolina

  • Denver, North Carolina - Denver
  • Huntersville, North Carolina - Huntersville

Alabama

  • Auburn, Alabama - Auburn

Louisiana

  • New Orleans, Louisiana - New Orleans

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2024-12-23
Est. Completion 2025-12
Phase Phase 2

What the Registry Record Tells You About NCT06752668

The ClinicalTrials.gov registry entry for NCT06752668 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (11% lower). The listed sponsor is Centessa Pharmaceuticals (UK) Limited, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06752668 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Georgia, Arizona.

Frequently Asked Questions

What is clinical trial NCT06752668 about?

NCT06752668 is a clinical study titled "A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia". 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 w...

What is the current status of trial NCT06752668?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2024-12-23. Estimated completion is 2025-12.

What conditions does trial NCT06752668 study?

This clinical trial studies the following conditions: Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2.

What interventions are being tested in trial NCT06752668?

The interventions under investigation include: Placebo (DRUG), ORX750 (DRUG).

Who is sponsoring clinical trial NCT06752668?

This trial is sponsored by Centessa Pharmaceuticals (UK) Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06752668 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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