A Study of ORX750 in Subjects with Narcolepsy and Idiopathic Hypersomnia

Phase 2

Not yet recruiting

• Conditions: Narcolepsy and Idiopathic Hypersomnia
• Interventions: Drug: ORX750; Drug: Placebo

• 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 First Posted: 2025-05-12
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 26

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

Arm && Interventions

Group	Intervention	Description
Narcolepsy Type 1: ORX750 and Placebo	ORX750	-
Narcolepsy Type 1: ORX750 and Placebo	Placebo	-
Narcolepsy Type 2: ORX750 and Placebo	Placebo	-
Idiopathic Hypersomnia: ORX750 and Placebo	Placebo	-
Idiopathic Hypersomnia: ORX750 and Placebo	ORX750	-
Narcolepsy Type 2: ORX750 and Placebo	ORX750	-

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 (9)

Centro Ricerche Cliniche Di Verona S.r.l.; 🇮🇹 Verona, Italy

Azienda Ospedaliera Policlinico Universitario Tor Vergata; 🇮🇹 Rome, Italy

Istituto Neurologico Mediterraneo Neuromed S.p.A.; 🇮🇹 Pozzilli, Italy

Azienda Unita Sanitaria Locale Di Bologna; 🇮🇹 Bologna, Italy

Instituto De Investigaciones Del Sueno S.L.; 🇪🇸 Madrid, Spain

Hospital Universitario Araba; 🇪🇸 Vitoria, Spain

Hospital Nuestra Senora De America; 🇪🇸 Madrid, Spain

Centre Hospitalier Universitaire De Montpellier; 🇫🇷 Montpellier Cedex 5, France

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Centro Ricerche Cliniche Di Verona S.r.l.

🇮🇹Verona, Italy

Giuseppe Plazzi

Site contact

+390458126509

giuseppe.plazzi@unibo.it