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NCT06752668PHASE2Recruiting

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Centessa Pharmaceuticals (UK) Limited

Start Date

12/23/2024

Completion Date

12/1/2026

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. 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.

Eligibility Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

ORX750

DRUG

Placebo

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Conditions

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Locations

Auburn, Alabama

Auburn, Alabama 36832

United States

Chandler, Arizona

Chandler, Arizona 85224

United States

Scottsdale, Arizona

Scottsdale, Arizona 85253

United States

Long Beach, California

Long Beach, California 90805

United States

Santa Ana, California

Santa Ana, California 92705

United States

Brandon, Florida

Brandon, Florida 33511

United States

Miami, Florida

Miami, Florida 33155

United States

Miami, Florida

Miami, Florida 33176

United States

Orlando, FL

Orlando, Florida 32807

United States

Winter Park, Florida

Winter Park, Florida 32789

United States

Atlanta, Georgia

Atlanta, Georgia 30281

United States

Atlanta, Georgia

Atlanta, Georgia 30328

United States

Riverdale, Georgia

Riverdale, Georgia 30274

United States

New Orleans, Louisiana

New Orleans, Louisiana 70127

United States

Newton, Massachusetts

Newton, Massachusetts 02459

United States

Southfield, Michigan

Southfield, Michigan 48075

United States

Sterling Heights, Michigan

Sterling Heights, Michigan 48314

United States

Henderson, Nevada

Henderson, Nevada 89052

United States

Denver, North Carolina

Denver, North Carolina 28037

United States

Huntersville, North Carolina

Huntersville, North Carolina 28078

United States

Cincinnati, Ohio

Cincinnati, Ohio 45245

United States

Cleveland, OH

Cleveland, Ohio 44106

United States

Dublin, Ohio

Dublin, Ohio 43017

United States

Willow Grove, Pennsylvania

Willow Grove, Pennsylvania 19090

United States

Columbia, South Carolina

Columbia, South Carolina 29201

United States

North Charleston, South Carolina

North Charleston, South Carolina 29406

United States

Austin, Texas

Austin, Texas 78731

United States

El Paso, TX

El Paso, Texas 79912

United States

San Antonio, Texas

San Antonio, Texas 78229

United States

Toronto, Ontario

Toronto, Ontario M5S 3A3

Canada

Leon, France

Léon, Bordeaux 33000

France

Bologna, Italy

Bologna, 40139

Italy

Pozzilli, Italy

Pozzilli, 86077

Italy

Verona, Italy

Verona, 37134

Italy

Madrid, Spain

Madrid, 28036

Spain

Madrid, Spain

Madrid, 28043

Spain

Vitoria-Gasteiz, Spain

Vitoria-Gasteiz, 01009

Spain