Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
148
Countries
3
Sites
9
Narcolepsy and Idiopathic Hypersomnia
To evaluate the safety and tolerability of ORX750
Key facts
- Sponsor
- Centessa Pharmaceuticals UK Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 9 Jun 2025 → ongoing
- Decision date (initial)
- 2025-05-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Centessa Pharmaceuticals (UK) Limited
External identifiers
- EU CT number
- 2024-518929-15-00
- ClinicalTrials.gov
- NCT06752668
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Pharmacodynamic, Efficacy, Others
To evaluate the safety and tolerability of ORX750
Secondary objectives 1
- To evaluate the PK of ORX750 and to evaluate the PD of ORX750 as assessed by the MWT and the ESS.
Conditions and MedDRA coding
Narcolepsy and Idiopathic Hypersomnia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028713 | Narcolepsy | 100000004852 |
| 20.0 | LLT | 10028715 | Narcolepsy with cataplexy | 10029205 |
| 21.1 | LLT | 10075058 | Idiopathic hypersomnia | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 2
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 2
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD11875794 · Product
- Active substance
- ORX750
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTESSA PHARMACEUTICALS UK LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11875897 · Product
- Active substance
- ORX750
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTESSA PHARMACEUTICALS UK LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11875901 · Product
- Active substance
- ORX750
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTESSA PHARMACEUTICALS UK LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11875781 · Product
- Active substance
- ORX750
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTESSA PHARMACEUTICALS UK LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centessa Pharmaceuticals UK Limited
- Sponsor organisation
- Centessa Pharmaceuticals UK Limited
- Address
- 3rd Floor, 1 Ashley Road 1 Ashley Road
- City
- Altrincham
- Postcode
- WA14 2DT
- Country
- United Kingdom
Scientific contact point
- Organisation
- Centessa Pharmaceuticals UK Limited
- Contact name
- Senior Vice President, Clinical Development
Public contact point
- Organisation
- Centessa Pharmaceuticals UK Limited
- Contact name
- Senior Vice President, Clinical Development
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Cambridge Cognition Limited ORG-100045478
|
Cambridge, United Kingdom | Other |
| Millmount Healthcare Limited ORG-100011724
|
Stamullen, Ireland | Code 14, Other |
| CliniChain B.V. ORG-100053495
|
Almere, Netherlands | Other |
| Syneos Health UK Limited ORG-100008519
|
Farnborough, United Kingdom | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture |
| Neonstone Limited ORG-100049164
|
Slough, United Kingdom | Other |
| PCI Pharma Services Germany GmbH ORG-100031981
|
Großbeeren, Germany | Code 14, Other |
| Celerion Inc. ORG-100029202
|
Lincoln, United States | Other, Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 8 |
| Clinilabs Inc. ORG-100048107
|
Eatontown, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 6 | 2 |
| Italy | Ongoing, recruiting | 18 | 4 |
| Spain | Authorised, recruitment pending | 10 | 3 |
| Rest of world
Canada, United States
|
— | 114 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Unité des Troubles du Sommeil, Département de Neurologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Bordeaux
Plateforme de recherche Neuropsychopharmocologique, Place Amelie Raba Leon, 33000, Bordeaux
Azienda Unita Sanitaria Locale Di Bologna
UOC Clinica Neurologica, Via Altura 3, 40139, Bologna
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Neurology, Via Atinense N. 18, 86077, Pozzilli
Centro Ricerche Cliniche Di Verona S.r.l.
Neurology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliera Policlinico Universitario Tor Vergata
UOC Neurologia/Neurofisiopatologia, Viale Oxford 81, 00133, Rome
Hospital Nuestra Senora De America
Neurophysiology and Sleep Disorders, Calle De Arturo Soria 103 105 107, 28043, Madrid
Instituto De Investigaciones Del Sueno S.L.
Unidad del Sueño, Calle Del Padre Damian 44, 28036, Madrid
Hospital Universitario Araba
Unidad del Sueño, Jose Achotegui Kalea S/N, 01009, Vitoria
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2025-06-09 | 2025-06-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 97 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518929-15-00 _Redacted | 7.0 (EU) |
| Protocol (for publication) | D4_Patient facing document_Scale 1_EN _Redacted | 1 |
| Protocol (for publication) | D4_Patient facing document_Scale 1_ES _Redacted | 1 |
| Protocol (for publication) | D4_Patient facing document_Scale 1_FR _Redacted | 1 |
| Protocol (for publication) | D4_Patient facing document_Scale 1_IT _Redacted | 1 |
| Protocol (for publication) | D4_Patient facing document_Scale 10_EN _Redacted | 2 |
| Protocol (for publication) | D4_Patient facing document_Scale 10_ES _Redacted | 2 |
| Protocol (for publication) | D4_Patient facing document_Scale 10_FR _Redacted | 2 |
| Protocol (for publication) | D4_Patient facing document_Scale 10_IT _Redacted | 2 |
| Protocol (for publication) | D4_Patient facing document_Scale 11_EN _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 11_ES _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 11_FR _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 11_IT _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 12_EN _Redacted | 3 |
| Protocol (for publication) | D4_Patient facing document_Scale 12_ES _Redacted | 3 |
| Protocol (for publication) | D4_Patient facing document_Scale 12_FR _Redacted | 3 |
| Protocol (for publication) | D4_Patient facing document_Scale 12_IT _Redacted | 3 |
| Protocol (for publication) | D4_Patient facing document_Scale 2_EN | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 2_ES | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 2_FR | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 2_IT | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 3_EN _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 3_ES _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 3_FR _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 3_IT _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 4_EN _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 4_ES _Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Scale 4_FR _Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Scale 4_IT _Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Scale 5_EN _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 5_ES _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 5_FR _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 5_IT _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 6_EN _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 6_ES _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 6_FR _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 6_IT _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 7_EN _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 7_ES _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 7_FR _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 7_IT _Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Scale 8 and 9_EN _Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Scale 8 and 9_ES _Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Scale 8 and 9_FR _Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Scale 8 and 9_IT _Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_Dr_to_Dr_Letter_ES | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_dr_to_dr_letter_FR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr_to_Dr_Letter_IT | 3.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_graphics concept_ES _Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphics concept_FR _Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Graphics concept_IT _Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_patient_brochure_ES | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient_brochure_FR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient_Brochure_IT | 3.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_poster_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_poster_FR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_poster_IT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_IT_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Home_Nursing_IT | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ NT1_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ NT2_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_IH_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES _Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT _Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Newborn Data collection ICF_FR _Redacted | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_IT_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening _ES_Redacted | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_FR | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_ES | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_IT | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_FR _Redacted | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ES | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_IT | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Genetic_IT _Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Testing_FR _Redacted | 3.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy notice_IT _Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_IT _Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientGo App copy_IT | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientGo EULA_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientGo Patient info sheet_IT | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientGo Privacy Policy_IT | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientGO Supplementary ICF_FR _Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Payment Card Letter_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PillConnect App ScreenReport_IT_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PillConnect User Manual_IT | 1.1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Reimb_Form_IT | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Material_Reimb_Proc_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Supplemental ICF for Optional Off-Site Nursing Visits | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Supplementary ICF_IT | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Travel and Reimbursement Policy_IT_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-518929-15-00 _Redacted | 7.0 (EU) |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-518929-15-00 _Redacted | 7.0 (EU) |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-518929-15-00 _Redacted | 7.0 (EU) |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-518929-15-00 _Redacted | 7.0 (EU) |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-07 | Italy | Acceptable 2025-05-05
|
2025-05-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-21 | Acceptable 2025-05-05
|
2025-05-21 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-05 | Italy | Acceptable with conditions 2025-12-16
|
2025-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-23 | Acceptable with conditions | 2026-01-07 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-23 | Italy | Acceptable with conditions | 2026-01-23 |