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NCT07096674 · ClinicalTrials.gov registry record · Phase 2

A Long-term Extension 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
90
Enrollment target
14
Study locations

NCT07096674: Recruiting Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1, sponsored by Centessa Pharmaceuticals (UK) Limited.

NCT07096674 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 90 participants, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (17% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07096674, 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
90 participants
Enrollment target
14
Study locations

Study Summary

This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

Primary Outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Interventions

  • DRUG ORX750

Study Locations (14)

Georgia

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

North Carolina

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

Texas

  • Austin, Texas - Austin
  • El Paso, Texas - El Paso

Alabama

  • Auburn, alabama - Auburn

California

  • Santa Ana, California - Santa Ana

Florida

  • Miami, Florida - Miami

Michigan

  • Sterling Heights, Michigan - Sterling Heights

Nevada

  • Hendersen, Navada - Henderson

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2025-08-12
Est. Completion 2026-04-30
Phase Phase 2

What NCT07096674 shows while recruiting

NCT07096674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (17% lower).

The record links to 3 conditions, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 1 intervention - of which ORX750 is the first listed.

NCT07096674 lists 14 locations in 11 states (Georgia, North Carolina, Texas).

Frequently Asked Questions

What is clinical trial NCT07096674 about?

NCT07096674 is a clinical study titled "A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia". This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

What is the current status of trial NCT07096674?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2025-08-12. Estimated completion is 2026-04-30.

What conditions does trial NCT07096674 study?

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

What interventions are being tested in trial NCT07096674?

The interventions under investigation include: ORX750 (DRUG).

Who is sponsoring clinical trial NCT07096674?

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

Where is trial NCT07096674 being conducted?

This trial has 14 study locations across Alabama, California, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT07096674, the US trial registry maintained by the National Library of Medicine. NCT07096674 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.