A Study of ORX750 in Subjects with Narcolepsy and Idiopathic Hypersomnia

Phase 2

Recruiting

• Conditions: Narcolepsy and Idiopathic Hypersomnia

• Registration Number: 2024-518929-15-00
• Lead Sponsor: Centessa Pharmaceuticals UK Limited

Brief Summary

To evaluate the safety and tolerability of ORX750

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-23
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Study First Posted: 2024-12-31
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-10
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.		Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.

Secondary Outcome Measures

Name	Time	Method
PK-Day 1: Cmax, tmax, and AUC0-last; Days 14 and 28: Cmax,ss, tmax, and AUCτ, and other PK parameters as appropriate.		PK-Day 1: Cmax, tmax, and AUC0-last; Days 14 and 28: Cmax,ss, tmax, and AUCτ, and other PK parameters as appropriate.
PD-mean sleep latency (average of the first 4 trials) in the MWT for ORX750 versus placebo and subjective daytime sleepiness using the ESS, including change from baseline to specified postdose time points.		PD-mean sleep latency (average of the first 4 trials) in the MWT for ORX750 versus placebo and subjective daytime sleepiness using the ESS, including change from baseline to specified postdose time points.

Trial Locations

Locations (24)

Auburn, Alabama; 🇺🇸 Auburn, Alabama, United States

Chandler, Arizona; 🇺🇸 Chandler, Arizona, United States

Scottsdale, Arizona; 🇺🇸 Scottsdale, Arizona, United States

Long Beach, California; 🇺🇸 Long Beach, California, United States

Santa Ana, California; 🇺🇸 Santa Ana, California, United States

Brandon, Florida; 🇺🇸 Brandon, Florida, United States

Miami, Florida; 🇺🇸 Miami, Florida, United States

Orlando, FL; 🇺🇸 Orlando, Florida, United States

Winter Park, Florida; 🇺🇸 Winter Park, Florida, United States

Atlanta, Georgia; 🇺🇸 Atlanta, Georgia, United States

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