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New sleepiness drug could change lives for narcolepsy and hypersomnia patients

NCT ID NCT06752668

Symptom relief Sponsor: Centessa Pharmaceuticals (UK) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called ORX750 (cleminorexton) in 248 adults with narcolepsy type 1, type 2, or idiopathic hypersomnia—conditions that cause severe daytime sleepiness. The drug mimics a natural brain protein that helps keep people awake. The main goals are to check safety and see if it reduces sleepiness and improves daily function.

Why investors are watching

Centessa Pharmaceuticals plc is running a phase 2a trial of its drug ORX750, called CRYSTAL-1, in people with narcolepsy and idiopathic hypersomnia, conditions that cause severe daytime sleepiness. The trial tests whether the drug, which mimics a brain protein called orexin, is safe and helps ease symptoms. For a small company like Centessa, this readout matters because ORX750 could become its main product, and a clear result will show whether the drug works in a broad group of sleep disorders.

If it works: If the trial shows ORX750 is safe and reduces daytime sleepiness, Centessa could move the drug into later-stage testing and potentially bring a new treatment to patients who have few options. A positive result could also strengthen the company's position with partners or investors.

If it fails: Trials often fail, and this one could show the drug is not effective or has safety problems, which would set the program back. A delay or unclear result could also hurt Centessa, since the company's value depends heavily on this drug's success.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 248 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18-65 years of age * BMI ≥17 and ≤37 kg/m2 * Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria * Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia * Is willing and able to adhere to additional protocol requirements Exclusion Criteria: * A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS). * Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

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Conditions

The condition(s) this trial relates to.

idiopathic hypersomnia narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic hypersomnia Narcolepsy type 1 Narcolepsy type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta, Georgia

    RECRUITING

    Atlanta, Georgia, 30281, United States

  • Atlanta, Georgia

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Auburn, Alabama

    RECRUITING

    Auburn, Alabama, 36832, United States

  • Austin, Texas

    RECRUITING

    Austin, Texas, 78731, United States

  • Bologna, Italy

    RECRUITING

    Bologna, 40139, Italy

  • Brandon, Florida

    RECRUITING

    Brandon, Florida, 33511, United States

  • Chandler, Arizona

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Cincinnati, Ohio

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Columbia, South Carolina

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • Denver, North Carolina

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Dublin, Ohio

    RECRUITING

    Dublin, Ohio, 43017, United States

  • El Paso, TX

    RECRUITING

    El Paso, Texas, 79912, United States

  • Henderson, Nevada

    RECRUITING

    Henderson, Nevada, 89052, United States

  • Huntersville, North Carolina

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Leon, France

    RECRUITING

    Léon, Bordeaux, 33000, France

  • Long Beach, California

    RECRUITING

    Long Beach, California, 90805, United States

  • Madrid, Spain

    RECRUITING

    Madrid, 28036, Spain

  • Madrid, Spain

    RECRUITING

    Madrid, 28043, Spain

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33155, United States

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33176, United States

  • New Orleans, Louisiana

    RECRUITING

    New Orleans, Louisiana, 70127, United States

  • Newton, Massachusetts

    RECRUITING

    Newton, Massachusetts, 02459, United States

  • North Charleston, South Carolina

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Orlando, FL

    RECRUITING

    Orlando, Florida, 32807, United States

  • Pozzilli, Italy

    RECRUITING

    Pozzilli, 86077, Italy

  • Riverdale, Georgia

    RECRUITING

    Riverdale, Georgia, 30274, United States

  • San Antonio, Texas

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Santa Ana, California

    RECRUITING

    Santa Ana, California, 92705, United States

  • Scottsdale, Arizona

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Southfield, Michigan

    RECRUITING

    Southfield, Michigan, 48075, United States

  • Sterling Heights, Michigan

    RECRUITING

    Sterling Heights, Michigan, 48314, United States

  • Toronto, Ontario

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

  • Verona, Italy

    RECRUITING

    Verona, 37134, Italy

  • Vitoria-Gasteiz, Spain

    RECRUITING

    Vitoria-Gasteiz, 01009, Spain

  • Willow Grove, Pennsylvania

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Winter Park, Florida

    RECRUITING

    Winter Park, Florida, 32789, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.